Spinal Cord InjuryNCT01765153
Precision Versus Endurance Training to Improve Walking After Chronic Incomplete SCI
A study testing Endurance and Precision in people with Spinal Cord Injury, run by University of Alberta at 1 site in Canada.
Trial summary
The objective of the study was to determine the efficacy of two forms of physical therapy training, one emphasizing precise, visually guided walking over obstacles and on targets (Precision Training), the other emphasizing mass practice of walking on a treadmill (Endurance Training). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Endurance and Precision
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2008to Sep 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- spinal cord injury equal or more than 7 months prior
- able to walk at least 5 meters independently (can use walking aids and braces)
- injury level between C1 and L1
- able to give informed consent
- able to attend training sessions 5x/week
Who cannot join
- head injury
- cognitive of musculoskeletal impairments that preclude participation in walking training
- seizures or implants in the head that would preclude participation in experiments with transcranial magnetic stimulation
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study was to determine the efficacy of two forms of physical therapy training, one emphasizing precise, visually guided walking over obstacles and on targets (Precision Training), the other emphasizing mass practice of walking on a treadmill (Endurance Training). The hypothesis was that visually guided training (Precision) may be especially efficacious because it engages the motor cortex, whose input may facilitate improvements in functional walking. Participants are individuals with a chronic (≥7 months post-injury), motor incomplete spinal cord injury (SCI), with no other problems that would preclude participation in an intensive training program. A randomized, single-blinded, cross-over design was used to randomly allocate participants to start with Precision or Endurance Training, identified as Training Phase I. Training was 5x/wk for 2 months, followed by a 2-month rest period, identified as Rest Period I. Participants then returned for 2-months of training in the other method, identified as Training Phase II, followed by another 2-month rest, Rest Period II. Measures of walking speed, distance, skill, confidence, as well as depression were obtained at least 3 times before any training, then monthly thereafter. Electrophysiological measures were taken before and after each phase of training and period of rest. Change scores were used to determine how each phase of training and rest influenced the scores (see below).
Read the detailed description
PARTICIPANTS: Inclusion criteria: 1) SCI from trauma or other stable lesions, 2) injury occurred ≥ 7 mo prior, 3) able to walk independently at least 5 m with a walking aid and/or braces, 4) injury level between C1-L1, 5) able to give informed consent, 6) able to attend training sessions 5x/week. Exclusion criteria: 1) head injury, 2) cognitive or musculoskeletal impairments that preclude participation in walking training, 3) seizures or implants in the head that would preclude participation in experiments using transcranial magnetic stimulation (TMS).
INTERVENTIONS:
Precision Training. Training was performed on a 15 m long track. The track contained obstacles and targets. Obstacles were made of Styrofoam blocks of 3 cm height each, varying in width from 4 cm to 20 cm in divisions of 4 cm increments (which must be cleared without touching), and targets were made of fabric circles, ranging in diameter from 7-10.5 cm (which must be totally obscured by their foot). The difficulty of the track was designed to have the participant achieve ~80% success. The emphasis was on accuracy, not speed.
Endurance Training. The aim of this training was mass practice. Participants walked on the treadmill, with body-weight support (BWS) and manual assistance if needed. The treadmill speed was initially set to be faster than their over ground walking speed as measured by the 10 MWT(ss). Participants were encouraged to walk for as far and as fast as possible with minimal rest periods. Progression involved reducing manual assistance and BWS, increasing walking speed and distance, while reducing rest breaks.
In both phases of training, a research assistant or volunteer recorded training parameters each session. The number of steps executed was measured with a step counter (StepWatch, Orthocare Innovations, USA), which was confirmed to be accurate with simultaneous manual counting prior to its use, and periodically during training sessions. The heart rate before and immediately after each bout of walking was measured with a heart rate monitor (Polar FT7, Polar, Canada). The total time, distance and walking speed for each walking bout was recorded.
MEASURES:
Measures were taken prior to all training at baseline (called Baseline I) and the end of each of the following intervals - one month of Training Phase I, two months of Training Phase I, one month of Rest Period I, two months of Rest Period I, one month of Training Phase II, two months of Training Phase II, one month of Rest Period II, two months of Rest Period II. To measure changes during the second phase of training, the baseline was the average of the one and two month measures of Rest Period I, henceforth called Baseline II.
STATISTICAL ANALYSIS: To determined if one type of training was superior to the other, we compared the change scores (i.e., post-training score minus pre-training score) from each type of training using a standard t-test or a Mann-Whitney U test, as appropriate. Since individuals with high compared to low walking function may respond to the training differently, we divided individuals based on their pretraining walking speed as measured by the 10 MWT(ss) (i.e., > or < 0.5 m/s). The change scores from each of these groups of individuals were then compared for each type of training using a standard t-test or a Mann-Whitney U test, as appropriate. To determine the time course for obtaining a treatment effect, we compared the change scores for the first month (i.e., outcome measure at end of 1 mo minus baseline) versus the second month (outcome measure at end of 2 mo minus at end of 1 mo) of training for each type of training, using a standard t-test or a Mann-Whitney U test, as appropriate. Retention of gains was followed for 2 months after each type of training. The outcome measures at the end of the 2 month rest period were compared to the measures immediately after the training, for individuals that made improvements greater than the standard error of measurement for each measure, using a paired t-test or Wilcoxon signed-rank test, as appropriate.
- Conditions
- Spinal Cord Injury
- Being tested
- Endurance, Precision
- Keywords
- physical therapy, rehabilitation, neuroplasticity
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnduranceBehavioural
Also called Treadmill walking training, Body-weight supported treadmill training
Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight can be used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training.
PrecisionBehavioural
Also called Skill walking training
Participants train daily to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto.
| Study group | Role | What they receive |
|---|---|---|
| Endurance first | Experimental | Participants to start with Endurance Training. Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight can be used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training was 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for training in the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest. Measures of walking speed, distance, skill, confidence, as well as mood were obtained at least 3 times before any training, then monthly thereafter. Receives: Behavioral: Endurance; Behavioral: Precision |
| Precision first | Experimental | Participants to start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training was 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight can be used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest. Measures of walking speed, distance, skill, confidence, as well as mood were obtained at least 3 times before any training, then monthly thereafter. Receives: Behavioral: Endurance; Behavioral: Precision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at Completion of Study
This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.
Measured: Change from Baseline I to the end of the study (i.e., end of Rest Period II, which was ~8 months after the beginning of the study)
Secondary outcomes (48)
Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 Months of Training Phase I
This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.
Measured: Change from Baseline I to 2 months of Training Phase I
Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the End of 2 Months of Rest Period I
This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.
Measured: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 Months of Training Phase II
This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.
Measured: Change from Baseline II to 2 months of Training Phase II
Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the End of 2 Months of Rest Period II
This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.
Measured: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
Change in 6 Minute Walk Test (6MWT) at 2 Months of Training Phase I
Participants walk for as far as possible in 6 min along a 25m hallway.
Measured: Change from Baseline I to 2 months of Training Phase I
Change in 6 Minute Walk Test (6MWT) at the End of 2 Months of Rest Period I
Participants walk for as far as possible in 6 min along a 25m hallway. Total distance walked in the time is measured. Results are calculated as : Distance walked at end of period - Distance walked at beginning of period.
Measured: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
Change in 6 Minute Walk Test (6MWT) at 2 Months of Training Phase II
Participants walk for as far as possible in 6 min along a 25m hallway. Total distance walked in the time is measured. Results are calculated as : Distance walked at end of period - Distance walked at beginning of period.
Measured: Change from Baseline II to 2 months of Training Phase II
Change in 6 Minute Walk Test (6MWT) at the End of 2 Months of Rest Period II
Participants walk for as far as possible in 6 min along a 25m hallway. Total distance walked in the time is measured. Results are calculated as : Distance walked at end of period - Distance walked at beginning of period.
Measured: Change from the end of Phase II training to 2 months of Rest Period II
Change in 10 Metre Walk Test at a Self-selected Speed [10MWT(ss)] at 2 Months of Training Phase I
Participants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.
Measured: Change from Baseline I to 2 months of Training Phase I
Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at the End of 2 Months of Rest Period I
Participants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.
Measured: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at 2 Months of Training Phase II
Participants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.
Measured: Change from Baseline II to 2 months of Training Phase II
Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at the End of 2 Months of Rest Period II
Participants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.
Measured: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at 2 Months of Training Phase I
Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.
Measured: Change from Baseline I to 2 months of Training Phase I
Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at the End of 2 Months of Rest Period I
Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.
Measured: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at 2 Months of Training Phase II
Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.
Measured: Change from Baseline II to 2 months of Training Phase II
Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at the End of 2 Months of Rest Period II
Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.
Measured: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at 2 Months of Training Phase I
Participants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.
Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.
Measured: Change from Baseline I to 2 months of Training Phase I
Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at the End of 2 Months of Rest Period I
Participants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.
Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.
Measured: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at 2 Months of Training Phase II
Participants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.
Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.
Measured: Change from Baseline II to 2 months of Training Phase II
Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at the End of 2 Months of Rest Period II
Participants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.
Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.
Measured: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at 2 Months of Training Phase I
Participants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.
Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.
Measured: Change from Baseline I to 2 months of Training Phase I
Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at the End of 2 Months of Rest Period I
Participants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.
Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.
Measured: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at 2 Months of Training Phase II
Participants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.
Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.
Measured: Change from Baseline II to 2 months of Training Phase II
Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at the End of 2 Months of Rest Period II
Participants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.
Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.
Measured: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
Change in Activities-specific Balance Confidence Scale (ABC) at 2 Months of Training Phase I
A survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage.
Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability.
Measured: Change from Baseline I to 2 months of Training Phase I
Change in Activities-specific Balance Confidence Scale (ABC) at the End of 2 Months of Rest Period I
A survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage.
Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability.
Measured: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
Change in Activities-specific Balance Confidence Scale (ABC) at 2 Months of Training Phase II
A survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage.
Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability.
Measured: Change from Baseline II to 2 months of Training Phase II
Change in Activities-specific Balance Confidence Scale (ABC) at the End of 2 Months of Rest Period II
A survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage.
Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability.
Measured: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 2 Months of Training Phase I
A 20 question survey to measure current level of depressive symptoms. The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60.
Results are reported as Final score - Initial score. A negative result indicates a lower level of depression.
Measured: Change from Baseline I to 2 months of Training Phase I
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at the End of 2 Months of Rest Period I
A 20 question survey to measure current level of depressive symptoms.The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60.
Results are reported as Final score - Initial score. A negative result indicates a lower level of depression.
Measured: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 2 Months of Training Phase II
A 20 question survey to measure current level of depressive symptoms.The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60.
Results are reported as Final score - Initial score. A negative result indicates a lower level of depression.
Measured: Change from Baseline II to 2 months of Training Phase II
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at the End of 2 Months of Rest Period II
A 20 question survey to measure current level of depressive symptoms.The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60.
Results are reported as Final score - Initial score. A negative result indicates a lower level of depression.
Measured: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
Change in Manual Muscle Test (MMT) at 2 Months of Training Phase I
The strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally).
Results are reported as Final score - Initial score. A positive result indicates an increase in strength.
Measured: Change from Baseline I to 2 months of Training Phase I
Change in Manual Muscle Test (MMT) at the End of 2 Months of Rest Period I
The strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally).
Results are reported as Final score - Initial score. A positive result indicates an increase in strength.
Measured: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
Change in Manual Muscle Test (MMT) at 2 Months of Training Phase II
The strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally). Results are reported as Final score - Initial score. A positive result indicates an increase in strength.
Measured: Change from Baseline II to 2 months of Training Phase II
Change in Manual Muscle Test (MMT) at the End of 2 Months of Rest Period II
The strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally).
Results are reported as Final score - Initial score. A positive result indicates an increase in strength.
Measured: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
Change in Cutaneomuscular Reflexes at 2 Months of Training Phase I
Reflexes are elicited in standing by electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG) in µV.
Measured: Change from Baseline I to 2 months of Training Phase I
Change in Cutaneomuscular Reflexes at the End of 2 Months of Rest Period I
Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing.
Measured: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
Change in Cutaneomuscular Reflexes at 2 Months of Training Phase II
Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing.
Measured: Change from Baseline II to 2 months of Training Phase II
Change in Cutaneomuscular Reflexes at the End of 2 Months of Rest Period II
Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing.
Measured: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
Change in Transcranial Magnetic Stimulation (TMS) at 2 Months of Training Phase I
Single-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs.
Measured: Change from Baseline I to 2 months of Training Phase I
Change in Transcranial Magnetic Stimulation (TMS) at the End of 2 Months of Rest Period I
Single-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs.
Measured: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
Change in Transcranial Magnetic Stimulation (TMS) at 2 Months of Training Phase II
Single-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs.
Measured: Change from Baseline II to 2 months of Training Phase II
Change in Transcranial Magnetic Stimulation (TMS) at the End of 2 Months of Rest Period II
Maximum evoked potentials were measured and compared to baseline measures for major muscle groups.
Measured: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
Change in Electromyography During Treadmill Walking at 2 Months of Training Phase I
Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.
Measured: Change from Baseline I to 2 months of Training Phase I
Change in Electromyography During Treadmill Walking at the End of 2 Months of Rest Period I
Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.
Measured: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
Change in Electromyography During Treadmill Walking at 2 Months of Training Phase II
Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.
Measured: Change from Baseline II to 2 months of Training Phase II
Change in Electromyography During Treadmill Walking at the End of 2 Months of Rest Period II
Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.
Measured: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startMar 2008
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Jaynie Yang, PhD, Principal investigator, University of AlbertaMonica Gorassini, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765153
- Sponsor's protocol ID
- Pro00003873
- Status last verified
- Jan 2017
- First submitted
- 30 Nov 2012
- Last updated
- 2 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Khan AS, Patrick SK, Roy FD, Gorassini MA, Yang JF. Training-Specific Neural Plasticity in Spinal Reflexes after Incomplete Spinal Cord Injury. Neural Plast. 2016;2016:6718763. doi: 10.1155/2016/6718763. Epub 2016 Sep 20.
PubMed 27725887Musselman KE, Yang JF. Spinal Cord Injury Functional Ambulation Profile: a preliminary look at responsiveness. Phys Ther. 2014 Feb;94(2):240-50. doi: 10.2522/ptj.20130071. Epub 2013 Oct 10.
PubMed 24114437
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Versus Endurance Training to Improve Walking After Chronic Incomplete SCI
- ClinicalTrials.gov ID
- NCT01765153
- Acronym / sponsor ID
- Pro00003873
- Conditions
- Spinal Cord Injury
- Keywords
- physical therapy, rehabilitation, neuroplasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Mar 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 10 Jan 2013 (estimated)
- Results
- Posted 2 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study was to determine the efficacy of two forms of physical therapy training, one emphasizing precise, visually guided walking over obstacles and on targets (Precision Training), the other emphasizing mass practice of walking on a treadmill (Endurance Training). The hypothesis was that visually guided training (Precision) may be especially efficacious because it engages the motor cortex, whose input may facilitate improvements in functional walking. Participants are individuals with a chronic (≥7 months post-injury), motor incomplete spinal cord injury (SCI), with no other problems that would preclude participation in an intensive training program. A randomized, single-blinded, cross-over design was used to randomly allocate participants to start with Precision or Endurance Training, identified as Training Phase I. Training was 5x/wk for 2 months, followed by a 2-month rest period, identified as Rest Period I. Participants then returned for 2-months of training in the other method, identified as Training Phase II, followed by another 2-month rest, Rest Period II. Measures of walking speed, distance, skill, confidence, as well as depression were obtained at least 3 times before any training, then monthly thereafter. Electrophysiological measures were taken before and after each phase of training and period of rest. Change scores were used to determine how each phase of training and rest influenced the scores (see below).
Detailed description
PARTICIPANTS: Inclusion criteria: 1) SCI from trauma or other stable lesions, 2) injury occurred ≥ 7 mo prior, 3) able to walk independently at least 5 m with a walking aid and/or braces, 4) injury level between C1-L1, 5) able to give informed consent, 6) able to attend training sessions 5x/week. Exclusion criteria: 1) head injury, 2) cognitive or musculoskeletal impairments that preclude participation in walking training, 3) seizures or implants in the head that would preclude participation in experiments using transcranial magnetic stimulation (TMS).
INTERVENTIONS:
Precision Training. Training was performed on a 15 m long track. The track contained obstacles and targets. Obstacles were made of Styrofoam blocks of 3 cm height each, varying in width from 4 cm to 20 cm in divisions of 4 cm increments (which must be cleared without touching), and targets were made of fabric circles, ranging in diameter from 7-10.5 cm (which must be totally obscured by their foot). The difficulty of the track was designed to have the participant achieve ~80% success. The emphasis was on accuracy, not speed.
Endurance Training. The aim of this training was mass practice. Participants walked on the treadmill, with body-weight support (BWS) and manual assistance if needed. The treadmill speed was initially set to be faster than their over ground walking speed as measured by the 10 MWT(ss). Participants were encouraged to walk for as far and as fast as possible with minimal rest periods. Progression involved reducing manual assistance and BWS, increasing walking speed and distance, while reducing rest breaks.
In both phases of training, a research assistant or volunteer recorded training parameters each session. The number of steps executed was measured with a step counter (StepWatch, Orthocare Innovations, USA), which was confirmed to be accurate with simultaneous manual counting prior to its use, and periodically during training sessions. The heart rate before and immediately after each bout of walking was measured with a heart rate monitor (Polar FT7, Polar, Canada). The total time, distance and walking speed for each walking bout was recorded.
MEASURES:
Measures were taken prior to all training at baseline (called Baseline I) and the end of each of the following intervals - one month of Training Phase I, two months of Training Phase I, one month of Rest Period I, two months of Rest Period I, one month of Training Phase II, two months of Training Phase II, one month of Rest Period II, two months of Rest Period II. To measure changes during the second phase of training, the baseline was the average of the one and two month measures of Rest Period I, henceforth called Baseline II.
STATISTICAL ANALYSIS: To determined if one type of training was superior to the other, we compared the change scores (i.e., post-training score minus pre-training score) from each type of training using a standard t-test or a Mann-Whitney U test, as appropriate. Since individuals with high compared to low walking function may respond to the training differently, we divided individuals based on their pretraining walking speed as measured by the 10 MWT(ss) (i.e., > or < 0.5 m/s). The change scores from each of these groups of individuals were then compared for each type of training using a standard t-test or a Mann-Whitney U test, as appropriate. To determine the time course for obtaining a treatment effect, we compared the change scores for the first month (i.e., outcome measure at end of 1 mo minus baseline) versus the second month (outcome measure at end of 2 mo minus at end of 1 mo) of training for each type of training, using a standard t-test or a Mann-Whitney U test, as appropriate. Retention of gains was followed for 2 months after each type of training. The outcome measures at the end of the 2 month rest period were compared to the measures immediately after the training, for individuals that made improvements greater than the standard error of measurement for each measure, using a paired t-test or Wilcoxon signed-rank test, as appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endurance first | Experimental | Behavioral: Endurance, Behavioral: PrecisionParticipants to start with Endurance Training. Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight can be used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training was 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for training in the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest. Measures of walking speed, distance, skill, confidence, as well as mood were obtained at least 3 times before any training, then monthly thereafter. |
| Precision first | Experimental | Behavioral: Endurance, Behavioral: PrecisionParticipants to start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training was 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight can be used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest. Measures of walking speed, distance, skill, confidence, as well as mood were obtained at least 3 times before any training, then monthly thereafter. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- spinal cord injury equal or more than 7 months prior
- able to walk at least 5 meters independently (can use walking aids and braces)
- injury level between C1 and L1
- able to give informed consent
- able to attend training sessions 5x/week
Key exclusion criteria (3 listed)
- head injury
- cognitive of musculoskeletal impairments that preclude participation in walking training
- seizures or implants in the head that would preclude participation in experiments with transcranial magnetic stimulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnduranceAlso: Treadmill walking training, Body-weight supported treadmill trainingParticipants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight can be used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. | Behavioural | Endurance first, Precision first |
| PrecisionAlso: Skill walking trainingParticipants train daily to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. | Behavioural | Endurance first, Precision first |
Primary outcome
Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at Completion of Study
Time frame: Change from Baseline I to the end of the study (i.e., end of Rest Period II, which was ~8 months after the beginning of the study)
This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.
48 secondary outcomes
Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 Months of Training Phase I
Time frame: Change from Baseline I to 2 months of Training Phase I
Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the End of 2 Months of Rest Period I
Time frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 Months of Training Phase II
Time frame: Change from Baseline II to 2 months of Training Phase II
Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the End of 2 Months of Rest Period II
Time frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
Change in 6 Minute Walk Test (6MWT) at 2 Months of Training Phase I
Time frame: Change from Baseline I to 2 months of Training Phase I
Change in 6 Minute Walk Test (6MWT) at the End of 2 Months of Rest Period I
Time frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
Change in 6 Minute Walk Test (6MWT) at 2 Months of Training Phase II
Time frame: Change from Baseline II to 2 months of Training Phase II
Change in 6 Minute Walk Test (6MWT) at the End of 2 Months of Rest Period II
Time frame: Change from the end of Phase II training to 2 months of Rest Period II
Change in 10 Metre Walk Test at a Self-selected Speed [10MWT(ss)] at 2 Months of Training Phase I
Time frame: Change from Baseline I to 2 months of Training Phase I
Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at the End of 2 Months of Rest Period I
Time frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at 2 Months of Training Phase II
Time frame: Change from Baseline II to 2 months of Training Phase II
Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at the End of 2 Months of Rest Period II
Time frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at 2 Months of Training Phase I
Time frame: Change from Baseline I to 2 months of Training Phase I
Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at the End of 2 Months of Rest Period I
Time frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at 2 Months of Training Phase II
Time frame: Change from Baseline II to 2 months of Training Phase II
Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at the End of 2 Months of Rest Period II
Time frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at 2 Months of Training Phase I
Time frame: Change from Baseline I to 2 months of Training Phase I
Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at the End of 2 Months of Rest Period I
Time frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at 2 Months of Training Phase II
Time frame: Change from Baseline II to 2 months of Training Phase II
Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at the End of 2 Months of Rest Period II
Time frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at 2 Months of Training Phase I
Time frame: Change from Baseline I to 2 months of Training Phase I
Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at the End of 2 Months of Rest Period I
Time frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at 2 Months of Training Phase II
Time frame: Change from Baseline II to 2 months of Training Phase II
Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at the End of 2 Months of Rest Period II
Time frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
Change in Activities-specific Balance Confidence Scale (ABC) at 2 Months of Training Phase I
Time frame: Change from Baseline I to 2 months of Training Phase I
Change in Activities-specific Balance Confidence Scale (ABC) at the End of 2 Months of Rest Period I
Time frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
Change in Activities-specific Balance Confidence Scale (ABC) at 2 Months of Training Phase II
Time frame: Change from Baseline II to 2 months of Training Phase II
Change in Activities-specific Balance Confidence Scale (ABC) at the End of 2 Months of Rest Period II
Time frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 2 Months of Training Phase I
Time frame: Change from Baseline I to 2 months of Training Phase I
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at the End of 2 Months of Rest Period I
Time frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 2 Months of Training Phase II
Time frame: Change from Baseline II to 2 months of Training Phase II
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at the End of 2 Months of Rest Period II
Time frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
Change in Manual Muscle Test (MMT) at 2 Months of Training Phase I
Time frame: Change from Baseline I to 2 months of Training Phase I
Change in Manual Muscle Test (MMT) at the End of 2 Months of Rest Period I
Time frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
Change in Manual Muscle Test (MMT) at 2 Months of Training Phase II
Time frame: Change from Baseline II to 2 months of Training Phase II
Change in Manual Muscle Test (MMT) at the End of 2 Months of Rest Period II
Time frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
Change in Cutaneomuscular Reflexes at 2 Months of Training Phase I
Time frame: Change from Baseline I to 2 months of Training Phase I
Change in Cutaneomuscular Reflexes at the End of 2 Months of Rest Period I
Time frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I
Change in Cutaneomuscular Reflexes at 2 Months of Training Phase II
Time frame: Change from Baseline II to 2 months of Training Phase II
Change in Cutaneomuscular Reflexes at the End of 2 Months of Rest Period II
Time frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27725887Khan AS, Patrick SK, Roy FD, Gorassini MA, Yang JF. Training-Specific Neural Plasticity in Spinal Reflexes after Incomplete Spinal Cord Injury. Neural Plast. 2016;2016:6718763. doi: 10.1155/2016/6718763. Epub 2016 Sep 20.
- Derived from this study: PubMed 24114437Musselman KE, Yang JF. Spinal Cord Injury Functional Ambulation Profile: a preliminary look at responsiveness. Phys Ther. 2014 Feb;94(2):240-50. doi: 10.2522/ptj.20130071. Epub 2013 Oct 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaynie Yang, PhD principal investigator
University of Alberta
Monica Gorassini, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurance and Precision in people with Spinal Cord Injury, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at Completion of Study (time frame: Change from Baseline I to the end of the study (i.e., end of Rest Period II, which was ~8 months after the beginning of the study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01765153, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.