Spinal Cord InjuriesNCT03011099
Improving Gait Performance in Individuals With Spinal Cord Injuries: an Intervention Using Robotic Exoskeletons
A study testing Robotic exoskeleton training and Conventional physical therapy in people with Spinal Cord Injuries, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether robotic exoskeleton training can improve walking performance after SCI as compared to conventional physical therapy. 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?
- Robotic exoskeleton training and Conventional physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Mar 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Motor Incomplete spinal cord injury, as classified by American Spinal Injury Association guidelines, above the lumbar level (T12 and above).
- Able to independently stand for two minutes with or without an assistive device and with or without orthoses distal to the knee.
- Male or non-pregnant woman
- ≥ 18-years of age
- At least 6 months after injury
- Height between 5'2" and 6'2" (150-188 cm)
- Weight ≤ 220 pounds (100 kg)
- Ability to perform informed consent
Who cannot join
- Presence of clinical signs of lower motor neuron injury
- History of severe neurologic injuries other than SCI (MS, CP, ALS, TBI, CVA, etc.)
- Severe comorbidities: active infections, heart, lung, or circulatory conditions, pressure ulcers.
- Documented severe osteoporosis affecting the hip and spine
- Severe spasticity in the lower extremities (Modified Ashworth ≥ 3) or uncontrolled clonus
- Unstable spine
Show all 16Show fewer
- Unhealed limb or pelvic fractures
- Skin issues that would prevent wearing the device
- Range of motion restrictions that would prevent subject from achieving a normal, reciprocal gait pattern, or would restrict a subject from completing normal sit to stand or stand to sit transitions.
- Upper extremity strength deficits that limit ability to balance with a front rolling walker or crutches.
- Heterotopic ossification that resists functional range of motion in lower extremities
- Contractures (>15 degrees at the hips or >20 degrees at the knees)
- Psychiatric or cognitive comorbidities resulting in motor planning or impulsivity concerns
- Colostomy
- Have received any physical therapy intervention within 3 months prior to enrolment in the study
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to investigate whether robotic exoskeleton training can improve walking performance after SCI as compared to conventional physical therapy.
- Conditions
- Spinal Cord Injuries
- Being tested
- Robotic exoskeleton training, Conventional physical therapy
- 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.
Robotic exoskeleton trainingDevice
During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
Conventional physical therapyOther
During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
| Study group | Role | What they receive |
|---|---|---|
| Robotic exoskeleton training | Experimental | During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise. Receives: Device: Robotic exoskeleton training |
| Conventional Physical Therapy | Active comparator | During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period. Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test
The 10 Meter Walk Test assesses the time taken to walk 10 meters.
Measured: baseline, week 4
Change in Walking Endurance as Assessed by the 6 Minute Walk Test
The 6 Minute Walk Test assesses the distance walked in 6 minutes.
Measured: baseline, week 4
Change in Dynamic Mobility Assessment as Determined by the Timed Up and Go Test
The Timed Up and Go test assessed the time it takes to stand from a sitting position, complete a 3 meter walk, and then return to sitting.
Measured: baseline, week 4
Change in Muscle Activity as Assessed by Surface Electromyography (EMG)
Surface EMG sensors will be placed on the skin of subjects' lower extremities and trunk to measure muscle activity. Only one participant data was analyzed. Emg was recorded from the soleus, gastrocnemius, tibialis anterior, rectus femoris, vastus medialis, bicep femoris and semitendinosus muscles. The outcome measure is the %age change between the baseline and 4 week assessments. Negative values denotes decrease in muscle activity at 4 week compared to baseline.
Measured: baseline, week 4
Change in Energy Expenditure During Walking as Assessed by Oxygen Cost
Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight.20 Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2).
Measured: baseline, week 4
Secondary outcomes (5)
Change in Gait Characteristics as Assessed by the GAITRite Walkway (Cadence)
Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. Cadence is measured as steps/min. Change in cadence is reported as difference between baseline and post assessment.
Measured: baseline, week 4
Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Length)
Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The change in step length between baseline and post assessment is reported. Negative value denotes decrease in step length.
Measured: baseline, week 4
Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Time)
Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The outcome measure is the difference in step time between pre and post assessment. Negative value denotes decrease in step time (implying faster step time at post).
Measured: baseline, week 4
Change in Lower Extremity Strength as Assessed by American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS)
The ASIA (American Spinal Injury Association) assessment protocol consists of two sensory examinations, a motor examination and a classification framework (the impairment scale) to quantify the severity of the spinal cord injury. The scale informs about the functionality of the patient. The range of scores is 0 to 5, and high values represent better outcome. Following is the description of the range:
0 = total paralysis
- = palpable or visible contraction
- = active movement, full range of motion (ROM) with gravity eliminated
- = active movement, full ROM against gravity
- = active movement, full ROM against gravity and moderate resistance in a muscle specific position
- = (normal) active movement, full ROM against gravity and full resistance in a functional muscle position expected from an otherwise unimpaired person
We report the difference between baseline and 4week assessments. Negative value denotes decrease at post assessment.
Measured: baseline, week 4
Exoskeleton User Feedback as Assessed by a Questionnaire
A questionnaire will be administered to allow participants to provide feedback regarding their experiences during training sessions with the exoskeleton. The units on a scale was used to measure the feedback. The range of the scale was 1-5. '1' refers to very satisfied and '5' refers to very dissatisfied. '1' refers to a better outcome.
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startJan 2014
- Primary completionMar 2016
- Study completionMar 2016
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 (1)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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Edward Davis, The University of Texas Health Science Center, Houston
- Investigators
- Matthew Davis, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011099
- Sponsor's protocol ID
- HSC-MS-13-0536
- Status last verified
- Mar 2018
- First submitted
- 3 Jan 2017
- Last updated
- 3 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Chang SH, Afzal T; TIRR SCI Clinical Exoskeleton Group; Berliner J, Francisco GE. Exoskeleton-assisted gait training to improve gait in individuals with spinal cord injury: a pilot randomized study. Pilot Feasibility Stud. 2018 Mar 5;4:62. doi: 10.1186/s40814-018-0247-y. eCollection 2018.
PubMed 29556414
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Gait Performance in Individuals With Spinal Cord Injuries: an Intervention Using Robotic Exoskeletons
- ClinicalTrials.gov ID
- NCT03011099
- Acronym / sponsor ID
- HSC-MS-13-0536
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Posted 3 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether robotic exoskeleton training can improve walking performance after SCI as compared to conventional physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic exoskeleton training | Experimental | Device: Robotic exoskeleton trainingDuring the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise. |
| Conventional Physical Therapy | Active comparator | Other: Conventional physical therapyDuring the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Motor Incomplete spinal cord injury, as classified by American Spinal Injury Association guidelines, above the lumbar level (T12 and above).
- Able to independently stand for two minutes with or without an assistive device and with or without orthoses distal to the knee.
- Male or non-pregnant woman
- ≥ 18-years of age
- At least 6 months after injury
Key exclusion criteria (16 listed)
- Presence of clinical signs of lower motor neuron injury
- History of severe neurologic injuries other than SCI (MS, CP, ALS, TBI, CVA, etc.)
- Severe comorbidities: active infections, heart, lung, or circulatory conditions, pressure ulcers.
- Documented severe osteoporosis affecting the hip and spine
- Severe spasticity in the lower extremities (Modified Ashworth ≥ 3) or uncontrolled clonus
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 |
|---|---|---|
| Robotic exoskeleton trainingDuring the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise. | Device | Robotic exoskeleton training |
| Conventional physical therapyDuring the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period. | Other | Conventional Physical Therapy |
Primary outcome
Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test
Time frame: baseline, week 4
The 10 Meter Walk Test assesses the time taken to walk 10 meters.
Change in Walking Endurance as Assessed by the 6 Minute Walk Test
Time frame: baseline, week 4
The 6 Minute Walk Test assesses the distance walked in 6 minutes.
Change in Dynamic Mobility Assessment as Determined by the Timed Up and Go Test
Time frame: baseline, week 4
The Timed Up and Go test assessed the time it takes to stand from a sitting position, complete a 3 meter walk, and then return to sitting.
Change in Muscle Activity as Assessed by Surface Electromyography (EMG)
Time frame: baseline, week 4
Surface EMG sensors will be placed on the skin of subjects' lower extremities and trunk to measure muscle activity. Only one participant data was analyzed. Emg was recorded from the soleus, gastrocnemius, tibialis anterior, rectus femoris, vastus medialis, bicep femoris and semitendinosus muscles. The outcome measure is the %age change between the baseline and 4 week assessments. Negative values denotes decrease in muscle activity at 4 week compared to baseline.
Change in Energy Expenditure During Walking as Assessed by Oxygen Cost
Time frame: baseline, week 4
Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight.20 Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2).
5 secondary outcomes
Change in Gait Characteristics as Assessed by the GAITRite Walkway (Cadence)
Time frame: baseline, week 4
Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Length)
Time frame: baseline, week 4
Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Time)
Time frame: baseline, week 4
Change in Lower Extremity Strength as Assessed by American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS)
Time frame: baseline, week 4
Exoskeleton User Feedback as Assessed by a Questionnaire
Time frame: week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29556414Chang SH, Afzal T; TIRR SCI Clinical Exoskeleton Group; Berliner J, Francisco GE. Exoskeleton-assisted gait training to improve gait in individuals with spinal cord injury: a pilot randomized study. Pilot Feasibility Stud. 2018 Mar 5;4:62. doi: 10.1186/s40814-018-0247-y. eCollection 2018.
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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.
Matthew Davis, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic exoskeleton training and Conventional physical therapy in people with Spinal Cord Injuries, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 8 inclusion and 16 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 3 Apr 2018. 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 United States. 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 3 Apr 2018). 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 Over Ground Gait Speed as Assessed by the 10 Meter Walk Test (time frame: baseline, week 4). The study lists 5 primary outcomes in all. 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 NCT03011099, which also lists 1 linked publication.
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 3 Apr 2018.