Spinal Cord InjuriesNCT03254797
Stepping Training Using External Feedback in Spinal Cord Injury Patients
A study testing Stepping training with feedback and Stepping training without feedback in people with Spinal Cord Injuries, run by Khon Kaen University at 1 site in Thailand.
Trial summary
Does a 4-week stepping training program with or without external feedback clinically change functional ability and reduce risk of fall of ambulatory patients with iSCI? Are there significant differences between 4-weeks stepping training with or without external feedback in ambulatory patients with iSCI? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Stepping training with feedback and Stepping training without feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteThailand
- Study dates
- 20 Aug 2017to 20 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Independent ambulatory patients with iSCI
- Non-traumatic or traumatic causes
- Independent walking with or without assistive devices at least 17 meters (Functional Independence Measure Locomotor (FIM-L) scores 5-7)
- Age at least 18 years
- Body mass index (BMI) between 18.5 - 29.9 kg/m2.
Who cannot join
- Any conditions or disorders that might affect ability to participate in the study and/or ambulatory ability of the subjects such as
- Brain function disorders
- Visual deficits that cannot be corrected using glasses or contact lens
- Musculoskeletal pain (with an intensity of pain more than 5 out of 10 on a numerical rating pain scale)
- Deformity of the musculoskeletal system
- Unable to follow a command of the tests
- Unstable medical conditions
- Color blindness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Stepping Training With External Feedback on Walking and Functional Ability in Ambulatory Patients With Spinal Cord Injury
Does a 4-week stepping training program with or without external feedback clinically change functional ability and reduce risk of fall of ambulatory patients with iSCI?
Are there significant differences between 4-weeks stepping training with or without external feedback in ambulatory patients with iSCI?
Read the detailed description
To compare effects of 4-week stepping training with or without external feedback on functional ability and incidence of falls in ambulatory patients with iSCI (between-group comparison).
To compare the change of functional ability in a group of 4-week stepping training with or without the utility of external feedback (within-group comparison).
- Conditions
- Spinal Cord Injuries
- Being tested
- Stepping training with feedback, Stepping training without feedback
- Keywords
- Rehabilitation, Neurological condition, Walking ability, Feedback, External information
- 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.
Stepping training with feedbackOther
Subjects stand in a step standing position with placing one leg on the load cells of the device and the other leg at the posterolateral direction to the trained leg outside the load cells, look at the displayed section which will be positioned at their eye level. Then subjects will be instructed to shift/take their body-weight onto the trained leg until the green zone of the displayed section is lightened. When the subjects can take a proper level of their body-weight onto the trained leg, the beep sound will be alarmed to trigger the subjects and therapist that the subjects can step the other leg forward to the marker. Then they have to do the same when steps the leg backward.
Stepping training without feedbackOther
Subjects stand in a step standing position with placing one leg on the load cells of the device and the other leg at the posterolateral direction to the trained leg outside the load cells. Then subjects will be instructed to shift/take their body-weight onto the trained leg as most as they can. If the subjects can take a proper level of their body-weight onto the trained leg, the subjects can step the other leg forward to the marker. Then they have to do the same when steps the leg backward.
| Study group | Role | What they receive |
|---|---|---|
| Stepping training with feedback | Experimental | Subjects will be instructed to perform the stepping task with external feedback continuously until 20 minutes (excluding resting periods) but without fatigue. Then they continue a training program of overground walking for 10 minutes.
They have to be involved in a training program of their groups 5 times/week, for 4 weeks in total. Receives: Other: Stepping training with feedback |
| Stepping training without feedback | Active comparator | Subjects will be instructed to perform the stepping task without external feedback continuously until 20 minutes (excluding resting periods) but without fatigue. Then they continue a training program of overground walking for 10 minutes.
They have to be involved in a training program of their groups 5 times/week, for 4 weeks in total. Receives: Other: Stepping training without feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of walking stability using Timed up and go test [TUGT]
The test was designed to measure mobility and dynamic balance control related to walking. Subjects will be instructed to stand up from a standard chair, walk at a fastest and safe speed for 3 meters, turn around a traffic cone, walk back and sit down on the chair with or without a walking device. Then the average time required for the 3 trials will be recorded.
Measured: prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program
Secondary outcomes (3)
Change of walking speed using 10 meter walk test (10MWT)
The test measures walking speed. Subjects will be instructed to walk at a prefer speed and fastest speed along a 10 meters walkway with or without walking device. The video recording will be captured over the 4 meters in the middle walkway in order to minimize acceleration and deceleration effects. Then the data will be converted to a walking speed using a formula; (v = s/t)
Measured: prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program
Change of lower limb muscle strength using Five times sit-to-stand [FTSST]
The test has used to quantify lower extremity motor strength. The time taken to complete 5 chair-rise cycles at a fastest and safe speed will be recorded for each subject. Then the average time required for the 3 trials will be used for data analysis.
Measured: prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program
Change of walking endurance using 6 minute walk test (6MWT)
The test measures the longest walking distance in 6 minute to reflect the responses of the cardiopulmonary and muscular systems. Subjects will be instructed to walk along a rectangular walkway as long as they can with a safety speed. They can walk with or without walking device in 6 minutes and are able to take a resting period as needed and continuing to walk. The distance covered after 6 minutes will be recorded.
Measured: prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start20 Aug 2017
- Primary completion20 Sep 2019
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sugalya Amatachaya, Khon Kaen University
- Investigators
- Sugalya Amatachaya, Principal investigator, School of Physical Therapy, Khon Kaen University, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254797
- Sponsor's protocol ID
- PHD/0194/2557
- Status last verified
- Jun 2020
- First submitted
- 15 Aug 2017
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ada L, Dean CM, Lindley R, Lloyd G. Improving community ambulation after stroke: the AMBULATE Trial. BMC Neurol. 2009 Feb 11;9:8. doi: 10.1186/1471-2377-9-8.
PubMed 19208261Amatachaya S, Amatachaya P, Keawsutthi M, Siritaratiwat W. External cues benefit walking ability of ambulatory patients with spinal cord injury. J Spinal Cord Med. 2013 Nov;36(6):638-44. doi: 10.1179/2045772312Y.0000000086. Epub 2013 Apr 12.
PubMed 24090447Amatachaya S, Keawsutthi M, Amatachaya P, Manimmanakorn N. Effects of external cues on gait performance in independent ambulatory incomplete spinal cord injury patients. Spinal Cord. 2009 Sep;47(9):668-73. doi: 10.1038/sc.2008.168. Epub 2009 Jan 13.
PubMed 19139759Amatachaya S, Naewla S, Srisim K, Arrayawichanon P, Siritaratiwat W. Concurrent validity of the 10-meter walk test as compared with the 6-minute walk test in patients with spinal cord injury at various levels of ability. Spinal Cord. 2014 Apr;52(4):333-6. doi: 10.1038/sc.2013.171. Epub 2014 Jan 21.
PubMed 24445972Amatachaya S, Wannapakhe J, Arrayawichanon P, Siritarathiwat W, Wattanapun P. Functional abilities, incidences of complications and falls of patients with spinal cord injury 6 months after discharge. Spinal Cord. 2011 Apr;49(4):520-4. doi: 10.1038/sc.2010.163. Epub 2010 Dec 14.
PubMed 21151192Baer G, Smith M. The recovery of walking ability and subclassification of stroke. Physiother Res Int. 2001;6(3):135-44. doi: 10.1002/pri.222.
PubMed 11725595Balasubramanian CK, Bowden MG, Neptune RR, Kautz SA. Relationship between step length asymmetry and walking performance in subjects with chronic hemiparesis. Arch Phys Med Rehabil. 2007 Jan;88(1):43-9. doi: 10.1016/j.apmr.2006.10.004.
PubMed 17207674Behrman AL, Bowden MG, Nair PM. Neuroplasticity after spinal cord injury and training: an emerging paradigm shift in rehabilitation and walking recovery. Phys Ther. 2006 Oct;86(10):1406-25. doi: 10.2522/ptj.20050212.
PubMed 17012645Behrman AL, Harkema SJ. Locomotor training after human spinal cord injury: a series of case studies. Phys Ther. 2000 Jul;80(7):688-700.
PubMed 10869131Bohannon RW. Manual muscle testing: does it meet the standards of an adequate screening test? Clin Rehabil. 2005 Sep;19(6):662-7. doi: 10.1191/0269215505cr873oa.
PubMed 16180603Bohannon RW, Smith J, Hull D, Palmeri D, Barnhard R. Deficits in lower extremity muscle and gait performance among renal transplant candidates. Arch Phys Med Rehabil. 1995 Jun;76(6):547-51. doi: 10.1016/s0003-9993(95)80509-5.
PubMed 7763154Brotherton SS, Krause JS, Nietert PJ. A pilot study of factors associated with falls in individuals with incomplete spinal cord injury. J Spinal Cord Med. 2007;30(3):243-50. doi: 10.1080/10790268.2007.11753932.
PubMed 17684890Brotherton SS, Krause JS, Nietert PJ. Falls in individuals with incomplete spinal cord injury. Spinal Cord. 2007 Jan;45(1):37-40. doi: 10.1038/sj.sc.3101909. Epub 2006 Feb 21.
PubMed 16491105Calancie B, Needham-Shropshire B, Jacobs P, Willer K, Zych G, Green BA. Involuntary stepping after chronic spinal cord injury. Evidence for a central rhythm generator for locomotion in man. Brain. 1994 Oct;117 ( Pt 5):1143-59. doi: 10.1093/brain/117.5.1143.
PubMed 7953595Capato TT, Tornai J, Avila P, Barbosa ER, Piemonte ME. Randomized controlled trial protocol: balance training with rhythmical cues to improve and maintain balance control in Parkinson's disease. BMC Neurol. 2015 Sep 7;15:162. doi: 10.1186/s12883-015-0418-x.
PubMed 26347052
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stepping Training With External Feedback on Walking and Functional Ability in Ambulatory Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03254797
- Acronym / sponsor ID
- PHD/0194/2557
- Conditions
- Spinal Cord Injuries
- Keywords
- Rehabilitation, Neurological condition, Walking ability, Feedback, External information
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 20 Aug 2017 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 21 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Does a 4-week stepping training program with or without external feedback clinically change functional ability and reduce risk of fall of ambulatory patients with iSCI?
Are there significant differences between 4-weeks stepping training with or without external feedback in ambulatory patients with iSCI?
Detailed description
To compare effects of 4-week stepping training with or without external feedback on functional ability and incidence of falls in ambulatory patients with iSCI (between-group comparison).
To compare the change of functional ability in a group of 4-week stepping training with or without the utility of external feedback (within-group comparison).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepping training with feedback | Experimental | Other: Stepping training with feedbackSubjects will be instructed to perform the stepping task with external feedback continuously until 20 minutes (excluding resting periods) but without fatigue. Then they continue a training program of overground walking for 10 minutes. They have to be involved in a training program of their groups 5 times/week, for 4 weeks in total. |
| Stepping training without feedback | Active comparator | Other: Stepping training without feedbackSubjects will be instructed to perform the stepping task without external feedback continuously until 20 minutes (excluding resting periods) but without fatigue. Then they continue a training program of overground walking for 10 minutes. They have to be involved in a training program of their groups 5 times/week, for 4 weeks in total. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Independent ambulatory patients with iSCI
- Non-traumatic or traumatic causes
- Independent walking with or without assistive devices at least 17 meters (Functional Independence Measure Locomotor (FIM-L) scores 5-7)
- Age at least 18 years
- Body mass index (BMI) between 18.5 - 29.9 kg/m2.
Key exclusion criteria (8 listed)
- Any conditions or disorders that might affect ability to participate in the study and/or ambulatory ability of the subjects such as
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 |
|---|---|---|
| Stepping training with feedbackSubjects stand in a step standing position with placing one leg on the load cells of the device and the other leg at the posterolateral direction to the trained leg outside the load cells, look at the displayed section which will be positioned at their eye level. Then subjects will be instructed to shift/take their body-weight onto the trained leg until the green zone of the displayed section is lightened. When the subjects can take a proper level of their body-weight onto the trained leg, the beep sound will be alarmed to trigger the subjects and therapist that the subjects can step the other leg forward to the marker. Then they have to do the same when steps the leg backward. | Other | Stepping training with feedback |
| Stepping training without feedbackSubjects stand in a step standing position with placing one leg on the load cells of the device and the other leg at the posterolateral direction to the trained leg outside the load cells. Then subjects will be instructed to shift/take their body-weight onto the trained leg as most as they can. If the subjects can take a proper level of their body-weight onto the trained leg, the subjects can step the other leg forward to the marker. Then they have to do the same when steps the leg backward. | Other | Stepping training without feedback |
Primary outcome
Change of walking stability using Timed up and go test [TUGT]
Time frame: prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program
The test was designed to measure mobility and dynamic balance control related to walking. Subjects will be instructed to stand up from a standard chair, walk at a fastest and safe speed for 3 meters, turn around a traffic cone, walk back and sit down on the chair with or without a walking device. Then the average time required for the 3 trials will be recorded.
3 secondary outcomes
Change of walking speed using 10 meter walk test (10MWT)
Time frame: prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program
Change of lower limb muscle strength using Five times sit-to-stand [FTSST]
Time frame: prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program
Change of walking endurance using 6 minute walk test (6MWT)
Time frame: prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Background: PubMed 19208261Ada L, Dean CM, Lindley R, Lloyd G. Improving community ambulation after stroke: the AMBULATE Trial. BMC Neurol. 2009 Feb 11;9:8. doi: 10.1186/1471-2377-9-8.
- Background: PubMed 24090447Amatachaya S, Amatachaya P, Keawsutthi M, Siritaratiwat W. External cues benefit walking ability of ambulatory patients with spinal cord injury. J Spinal Cord Med. 2013 Nov;36(6):638-44. doi: 10.1179/2045772312Y.0000000086. Epub 2013 Apr 12.
- Background: PubMed 19139759Amatachaya S, Keawsutthi M, Amatachaya P, Manimmanakorn N. Effects of external cues on gait performance in independent ambulatory incomplete spinal cord injury patients. Spinal Cord. 2009 Sep;47(9):668-73. doi: 10.1038/sc.2008.168. Epub 2009 Jan 13.
- Background: PubMed 24445972Amatachaya S, Naewla S, Srisim K, Arrayawichanon P, Siritaratiwat W. Concurrent validity of the 10-meter walk test as compared with the 6-minute walk test in patients with spinal cord injury at various levels of ability. Spinal Cord. 2014 Apr;52(4):333-6. doi: 10.1038/sc.2013.171. Epub 2014 Jan 21.
- Background: PubMed 21151192Amatachaya S, Wannapakhe J, Arrayawichanon P, Siritarathiwat W, Wattanapun P. Functional abilities, incidences of complications and falls of patients with spinal cord injury 6 months after discharge. Spinal Cord. 2011 Apr;49(4):520-4. doi: 10.1038/sc.2010.163. Epub 2010 Dec 14.
- Background: PubMed 11725595Baer G, Smith M. The recovery of walking ability and subclassification of stroke. Physiother Res Int. 2001;6(3):135-44. doi: 10.1002/pri.222.
- Background: PubMed 17207674Balasubramanian CK, Bowden MG, Neptune RR, Kautz SA. Relationship between step length asymmetry and walking performance in subjects with chronic hemiparesis. Arch Phys Med Rehabil. 2007 Jan;88(1):43-9. doi: 10.1016/j.apmr.2006.10.004.
- Background: PubMed 17012645Behrman AL, Bowden MG, Nair PM. Neuroplasticity after spinal cord injury and training: an emerging paradigm shift in rehabilitation and walking recovery. Phys Ther. 2006 Oct;86(10):1406-25. doi: 10.2522/ptj.20050212.
- Background: PubMed 10869131Behrman AL, Harkema SJ. Locomotor training after human spinal cord injury: a series of case studies. Phys Ther. 2000 Jul;80(7):688-700.
- Background: PubMed 16180603Bohannon RW. Manual muscle testing: does it meet the standards of an adequate screening test? Clin Rehabil. 2005 Sep;19(6):662-7. doi: 10.1191/0269215505cr873oa.
- Background: PubMed 7763154Bohannon RW, Smith J, Hull D, Palmeri D, Barnhard R. Deficits in lower extremity muscle and gait performance among renal transplant candidates. Arch Phys Med Rehabil. 1995 Jun;76(6):547-51. doi: 10.1016/s0003-9993(95)80509-5.
- Background: PubMed 17684890Brotherton SS, Krause JS, Nietert PJ. A pilot study of factors associated with falls in individuals with incomplete spinal cord injury. J Spinal Cord Med. 2007;30(3):243-50. doi: 10.1080/10790268.2007.11753932.
- Individual participant dataSharing planned: No
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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.
Sugalya Amatachaya principal investigator
School of Physical Therapy, Khon Kaen University, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepping training with feedback and Stepping training without feedback in people with Spinal Cord Injuries, run by Khon Kaen University at 1 site in Thailand.
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 8 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 16 Jun 2020. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of walking stability using Timed up and go test [TUGT] (time frame: prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program). 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 NCT03254797, which also lists 24 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 16 Jun 2020.