Complete Spinal Cord InjuryNCT03057652
Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training
A study testing ReWalk, EKSO and REX in people with Complete Spinal Cord Injury and Incomplete Spinal Cord Injury, 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 develop an algorithmic-based evaluation and treatment approach for wearable robotic exoskeleton (WRE) gait training for patients with neurological conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Complete Spinal Cord Injury, Incomplete Spinal Cord Injury, Acquired Brain Injury
- What is being tested?
- ReWalk, EKSO and REX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Dec 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Spinal Cord Injury Inclusion Criteria:
- Male or non-pregnant female
- ≥18 years of age
- Chronic (> 6 mo post) injury
- Diagnosis of spinal cord injury
- Able to achieve adequate fit within exoskeleton
- Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit
- Weight <220 pounds
- Intact skin on all surfaces in contact with device and load bearing surfaces
- Ability to perform informed consent
- Cognitively intact and able to follow directions and demonstrate learning capability
Spinal Cord Injury Exclusion Criteria:
- Pregnancy
- Spinal instability
- Non-English speaking
- Unhealed limb or pelvic fractures or any condition restricting weight bearing in limbs
- Diagnosis of other neurological injury other than SCI such as CVA, MS, ABI, CP
- Uncontrolled spasticity (≥3 on Modified Ashworth Scale)[21]
- Colostomy
- Decreased range of motion or contractures in legs (>10° at hips, knees or ankles)
- Uncontrolled autonomic dysreflexia
- Unresolved deep vein thrombosis
- Inability to tolerate standing due to cardiovascular issues or orthostatic hypotension
- Severe comorbidities: active infections, heart, lung, or circulatory conditions
- Pressure sores, impaired skin integrity
Acquired Brain Injury(ABI) Inclusion Criteria:
- Male or non-pregnant female
- ≥18 years of age
- Chronic (> 6 mo post) injury
- Able to achieve adequate fit within exoskeleton
- Ability to perform informed consent
- Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit
- Weight <220 pounds
- Intact skin on all surfaces in contact with device and load bearing surfaces
- Cognitively intact and able to follow directions and demonstrate learning capability
Acquired Brain Injury(ABI) Exclusion Criteria:
- Pregnancy
- Spinal instability
- Non-English speaking
- Unhealed limb or pelvic fractures or any condition restricting weight bearing in limbs
- Diagnosis of other neurological injury other than ABI such as SCI, MS, TBI, CP
- Decreased range of motion or contractures in legs (>10° at hips, knees or ankles)
- Inability to tolerate standing due to cardiovascular issues or orthostatic hypotension
- Pressure sores, impaired skin integrity
- Uncontrolled spasticity (≥3 on Modified Ashworth Scale)
- Colostomy
- Severe comorbidities: active infections, heart, lung, or circulatory conditions
- Unresolved deep vein thrombosis
Multiple Sclerosis (MS) Inclusion Criteria:
- Male or non-pregnant female
- ≥18 years of age
- Chronic (> 6 mo post) injury
- Diagnosis of multiple sclerosis
- Ability to perform informed consent
- Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit
- Weight <220 pounds
- Able to achieve adequate fit within exoskeleton
- Intact skin on all surfaces in contact with device and load bearing surfaces
- Cognitively intact and able to follow directions and demonstrate learning capability
Multiple Sclerosis (MS) Exclusion Criteria:
- Pregnancy
- Spinal instability
- Non-English speaking
- Unhealed limb or pelvic fractures or any condition restricting weight bearing in limbs
- Decreased range of motion or contractures in legs (>10° at hips, knees or ankles)
- Inability to tolerate standing due to cardiovascular issues or orthostatic hypotension
- Uncontrolled autonomic dysreflexia
- Unresolved deep vein thrombosis
- Pressure sores, impaired skin integrity
- Uncontrolled spasticity (≥3 on Modified Ashworth Scale)
- Colostomy
- Severe comorbidities: active infections, heart, lung, or circulatory conditions[23,24]
- Diagnosis of other neurological injury other than MS such as CVA, SCI, ABI, CP
- MS Relapse in 3 months prior to recruitment
Able Bodied Inclusion Criteria:
- Male or non-pregnant female
- ≥18 years of age
- Weight <220 pounds
- Cognitively intact and able to follow directions and demonstrate learning capability[23]
- Healthy individuals with no history or diagnosis of neurological injury
- Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit
- Able to achieve adequate fit within exoskeleton
- Intact skin on all surfaces in contact with device and load bearing surfaces
- Ability to perform informed consent[24]
Able Bodied Exclusion Criteria:
- Pregnancy
- Spinal instability
- Non-English speaking
- Unhealed limb or pelvic fractures or any condition restricting weight bearing in limbs
- Diagnosis of neurological injury such as CVA, SCI, ABI, CP, MS
- Decreased range of motion or contractures in legs (>10° at hips, knees or ankles)
- Severe comorbidities: active infections, heart, lung, or circulatory conditions
- Colostomy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
TIRR Memorial Hermann
Houston, Texas, 77030
Shuo-Hsiu Chang, PT, PhD, 713-799-7016, Shuo-Hsiu.Chang@uth.tmc.edu
Marcie Kern, PT, MS, 713-799-6995, Marcie.Kern@memorialhermann.org
About this study
The purpose of this study is to develop an algorithmic-based evaluation and treatment approach for wearable robotic exoskeleton (WRE) gait training for patients with neurological conditions.
- Conditions
- Complete Spinal Cord Injury, Incomplete Spinal Cord Injury, Acquired Brain Injury, Multiple Sclerosis
- Being tested
- ReWalk, EKSO, REX
- Medical subject headings
- Brain Injuries, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReWalkDevice
ReWalk is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.
ReWalk training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. ReWalk phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.
EKSODevice
EKSO is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.
EKSO training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. EKSO phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.
REXDevice
REX is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.
REX training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. REX phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.
| Study group | Role | What they receive |
|---|---|---|
| ReWalk, then EKSO, then REX | Experimental | Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device. Receives: Device: ReWalk; Device: EKSO; Device: REX |
| ReWalk, then REX, then EKSO | Experimental | Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device. Receives: Device: ReWalk; Device: EKSO; Device: REX |
| EKSO, then ReWalk, then REX | Experimental | Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device. Receives: Device: ReWalk; Device: EKSO; Device: REX |
| EKSO, then REX, then ReWalk | Experimental | Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device. Receives: Device: ReWalk; Device: EKSO; Device: REX |
| REX, then EKSO, then ReWalk | Experimental | Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device. Receives: Device: ReWalk; Device: EKSO; Device: REX |
| REX, then ReWalk, then EKSO | Experimental | Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device. Receives: Device: ReWalk; Device: EKSO; Device: REX |
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 without WRE
The 10 Meter Walk Test (10MWT) will assess subject's self-selected gait speed.
Measured: within one week before start of WRE training, within 2 weeks after start of WRE training
Change in walking endurance as assessed by the 6 Minute Walk Test without WRE
The 6 Minute Walk Test (6MWT) assesses the distance walked in 6 minutes.
Measured: within one week before start of WRE training, within 2 weeks after start of WRE training
Change in muscle activity as assessed by electromyography (EMG) during 10MWT without WRE
Surface EMG sensors will be placed on the skin of subjects' lower extremities during 10MWT.
Measured: within one week before start of WRE training, within 2 weeks after start of WRE training
Change in muscle activity as assessed by electromyography (EMG) during 6MWT without WRE
Surface EMG sensors will be placed on the skin of subjects' lower extremities during 6MWT.
Measured: within one week before start of WRE training, within 2 weeks after start of WRE training
Change in energy expenditure as assessed by oxygen consumption during 10MWT without WRE
Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2). This task will be performed during the 10MWT.
Measured: within one week before start of WRE training, within 2 weeks after start of WRE training
Change in energy expenditure as assessed by oxygen consumption during 6MWT without WRE
Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2). This task will be performed during the 6MWT.
Measured: within one week before start of WRE training, within 2 weeks after start of WRE training
Change in gait kinematics as assessed by lower extremity joint excursion without WRE
Infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using motion capture system.
Measured: within one week before start of WRE training, within 2 weeks after start of WRE training
Change in gait kinematics as assessed by lower extremity joint angular velocities without WRE
Infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using motion capture system.
Measured: within one week before start of WRE training, within 2 weeks after start of WRE training
Secondary outcomes (20)
Bone mineral density as assessed by whole body scan
Subjects will undergo whole body bone scan according to standardized protocols.
Measured: within one month before start of WRE training
Cognitive impairment as assessed by Folstein Mini Mental State Examination
Folstein Mini Mental State Examination provides information about orientation, attention, learning, calculation, delayed recall, and construction.
Measured: within one month before start of WRE training
Lower Extremity Muscle Strength as assessed by using a force gauge such as a handheld dynamometer
We will measure lower extremity muscle strength using a force gauge such as a handheld dynamometer.
Measured: within one month before start of WRE training
Spasticity as assessed by the Modified Ashworth Scale (MAS)
The Modified Ashworth Scale will be used to measure spasticity in lower limb.
Measured: within one month before start of WRE training
Range of motion for lower extremity joints as assessed by manual examination
Range of joint motion of bilateral hip, knee and ankle joints. Subject will lie down on an examination table.
Measured: within one month before start of WRE training
Stability during the maximum distance an individual can reach forward from a seated position as assessed by Modified Functional Reach (MFR)
Assesses a patient's stability by measuring the maximum distance an individual can reach forward from a seated position.
Measured: within one month before start of WRE training
Walking ability in ambulatory individuals with SC as assessed by Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI):
Assesses functional walking ability in ambulatory individuals with SCI.
Measured: within one month before start of WRE training
Amount of physical assistance needed for walking following paralysis resulted from SCI as assessed by Walking Index of Spinal Cord Injury (WISCI-II)
This test is performed by SCI population.
Measured: within one month before start of WRE training
Motor recovery after stroke as assessed by Fugl-Meyer Assessment
Evaluates and measures recovery in post-stroke hemiplegic individuals.
Measured: within one month before start of WRE training
Confidence in performing various ambulatory activities as assessed by Activities-Specific Balance Confidence Scale
Measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness. This is performed in ABI and MS population.
Measured: within one month before start of WRE training
User feedback as assessed by a questionnaire
A questionnaire will be administered to allow participants to provide feedback regarding their experiences during intervention.
Measured: within one month before start of WRE training
Over ground gait speed as assessed by the 10 Meter Walk Test while wearing WRE
The 10 Meter Walk Test (10MWT) will assess subject's self-selected gait speed. After WRE training has been completed, subjects will perform 10MWT while ambulating in the WRE.
Measured: within one month before start of WRE training
Change in walking endurance as assessed by the 6 Minute Walk Test while wearing WRE
The 6 Minute Walk Test (6MWT) assesses the distance walked in 6 minutes. After WRE training has been completed, subjects will perform 6MWT while ambulating in the WRE.
Measured: within one month before start of WRE training
Change in muscle activity as assessed by electromyography (EMG) during 10MWT while wearing WRE
Surface EMG sensors will be placed on the skin of subjects' lower extremities during 10MWT. After WRE training has been completed, subjects will be assessed by EMG during the 10MWT while ambulating in the WRE.
Measured: within one month before start of WRE training
Change in muscle activity as assessed by electromyography (EMG) during 6MWT while wearing WRE
Surface EMG sensors will be placed on the skin of subjects' lower extremities during 6MWT. After WRE training has been completed, subjects will be assessed by EMG during the 6MWT while ambulating in the WRE.
Measured: within one month before start of WRE training
Change in energy expenditure as assessed by oxygen consumption during 10MWT while wearing WRE
Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2). This task will be performed during the 10MWT. After WRE training has been completed, oxygen consumption will be assessed in subjects during the 10MWT while ambulating in the WRE.
Measured: within one month before start of WRE training
Change in energy expenditure as assessed by oxygen consumption during 6MWT while wearing WRE
Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2). This task will be performed during the 6MWT. After WRE training has been completed, oxygen consumption will be assessed in subjects during the 10MWT while ambulating in the WRE.
Measured: within one month before start of WRE training
Change in gait kinematics as assessed by lower extremity joint excursion while wearing WRE
Infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using motion capture system. After WRE training has been completed, subjects will be assessed while ambulating in the WRE.
Measured: within one month before start of WRE training
Change in gait kinematics as assessed by lower extremity joint angular velocities while wearing WRE
Infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using motion capture system. After WRE training has been completed, subjects will be assessed while ambulating in the WRE.
Measured: within one month before start of WRE training
Change in H-reflex of soleus muscle as assessed by electromyography (EMG)
The tibialis nerve will be stimulated, and the size of each H-reflex will be measured as the peak-to-peak amplitude of the non-rectified EMG trace.
Measured: within one week before start of WRE training, within 2 weeks after start of WRE training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study startMar 2016
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complete 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
- Model description
- Each of the participants will receive training with each of the 3 wearable robotic exoskeletons (WRE) examined in this study, and the order of receipt will be randomized.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuo-Hsiu Chang, The University of Texas Health Science Center, Houston
- Investigators
- Shuo-Hsiu Chang, PT, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057652
- Sponsor's protocol ID
- HSC-MS-15-0923
- Status last verified
- May 2022
- First submitted
- 15 Feb 2017
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Zhu F, Kern M, Fowkes E, Afzal T, Contreras-Vidal JL, Francisco GE, Chang SH. Effects of an exoskeleton-assisted gait training on post-stroke lower-limb muscle coordination. J Neural Eng. 2021 Jun 4;18(4). doi: 10.1088/1741-2552/abf0d5.
PubMed 33752175
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training
- ClinicalTrials.gov ID
- NCT03057652
- Acronym / sponsor ID
- HSC-MS-15-0923
- Conditions
- Complete Spinal Cord Injury, Incomplete Spinal Cord Injury, Acquired Brain Injury, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 20 Feb 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.
The purpose of this study is to develop an algorithmic-based evaluation and treatment approach for wearable robotic exoskeleton (WRE) gait training for patients with neurological conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Each of the participants will receive training with each of the 3 wearable robotic exoskeletons (WRE) examined in this study, and the order of receipt will be randomized.
| Arm | Type | Receives |
|---|---|---|
| ReWalk, then EKSO, then REX | Experimental | Device: ReWalk, Device: EKSO, Device: REXSubjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device. |
| ReWalk, then REX, then EKSO | Experimental | Device: ReWalk, Device: EKSO, Device: REXSubjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device. |
| EKSO, then ReWalk, then REX | Experimental | Device: ReWalk, Device: EKSO, Device: REXSubjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device. |
| EKSO, then REX, then ReWalk | Experimental | Device: ReWalk, Device: EKSO, Device: REXSubjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device. |
| REX, then EKSO, then ReWalk | Experimental | Device: ReWalk, Device: EKSO, Device: REXSubjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device. |
| REX, then ReWalk, then EKSO | Experimental | Device: ReWalk, Device: EKSO, Device: REXSubjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| ReWalkReWalk is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices. ReWalk training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. ReWalk phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours. | Device | EKSO, then REX, then ReWalk, EKSO, then ReWalk, then REX, REX, then EKSO, then ReWalk, REX, then ReWalk, then EKSO, ReWalk, then EKSO, then REX, ReWalk, then REX, then EKSO |
| EKSOEKSO is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices. EKSO training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. EKSO phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours. | Device | EKSO, then REX, then ReWalk, EKSO, then ReWalk, then REX, REX, then EKSO, then ReWalk, REX, then ReWalk, then EKSO, ReWalk, then EKSO, then REX, ReWalk, then REX, then EKSO |
| REXREX is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices. REX training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. REX phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours. | Device | EKSO, then REX, then ReWalk, EKSO, then ReWalk, then REX, REX, then EKSO, then ReWalk, REX, then ReWalk, then EKSO, ReWalk, then EKSO, then REX, ReWalk, then REX, then EKSO |
Primary outcome
Change in over ground gait speed as assessed by the 10 Meter Walk Test without WRE
Time frame: within one week before start of WRE training, within 2 weeks after start of WRE training
The 10 Meter Walk Test (10MWT) will assess subject's self-selected gait speed.
Change in walking endurance as assessed by the 6 Minute Walk Test without WRE
Time frame: within one week before start of WRE training, within 2 weeks after start of WRE training
The 6 Minute Walk Test (6MWT) assesses the distance walked in 6 minutes.
Change in muscle activity as assessed by electromyography (EMG) during 10MWT without WRE
Time frame: within one week before start of WRE training, within 2 weeks after start of WRE training
Surface EMG sensors will be placed on the skin of subjects' lower extremities during 10MWT.
Change in muscle activity as assessed by electromyography (EMG) during 6MWT without WRE
Time frame: within one week before start of WRE training, within 2 weeks after start of WRE training
Surface EMG sensors will be placed on the skin of subjects' lower extremities during 6MWT.
Change in energy expenditure as assessed by oxygen consumption during 10MWT without WRE
Time frame: within one week before start of WRE training, within 2 weeks after start of WRE training
Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2). This task will be performed during the 10MWT.
Change in energy expenditure as assessed by oxygen consumption during 6MWT without WRE
Time frame: within one week before start of WRE training, within 2 weeks after start of WRE training
Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2). This task will be performed during the 6MWT.
Change in gait kinematics as assessed by lower extremity joint excursion without WRE
Time frame: within one week before start of WRE training, within 2 weeks after start of WRE training
Infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using motion capture system.
Change in gait kinematics as assessed by lower extremity joint angular velocities without WRE
Time frame: within one week before start of WRE training, within 2 weeks after start of WRE training
Infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using motion capture system.
20 secondary outcomes
Bone mineral density as assessed by whole body scan
Time frame: within one month before start of WRE training
Cognitive impairment as assessed by Folstein Mini Mental State Examination
Time frame: within one month before start of WRE training
Lower Extremity Muscle Strength as assessed by using a force gauge such as a handheld dynamometer
Time frame: within one month before start of WRE training
Spasticity as assessed by the Modified Ashworth Scale (MAS)
Time frame: within one month before start of WRE training
Range of motion for lower extremity joints as assessed by manual examination
Time frame: within one month before start of WRE training
Stability during the maximum distance an individual can reach forward from a seated position as assessed by Modified Functional Reach (MFR)
Time frame: within one month before start of WRE training
Walking ability in ambulatory individuals with SC as assessed by Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI):
Time frame: within one month before start of WRE training
Amount of physical assistance needed for walking following paralysis resulted from SCI as assessed by Walking Index of Spinal Cord Injury (WISCI-II)
Time frame: within one month before start of WRE training
Motor recovery after stroke as assessed by Fugl-Meyer Assessment
Time frame: within one month before start of WRE training
Confidence in performing various ambulatory activities as assessed by Activities-Specific Balance Confidence Scale
Time frame: within one month before start of WRE training
User feedback as assessed by a questionnaire
Time frame: within one month before start of WRE training
Over ground gait speed as assessed by the 10 Meter Walk Test while wearing WRE
Time frame: within one month before start of WRE training
Change in walking endurance as assessed by the 6 Minute Walk Test while wearing WRE
Time frame: within one month before start of WRE training
Change in muscle activity as assessed by electromyography (EMG) during 10MWT while wearing WRE
Time frame: within one month before start of WRE training
Change in muscle activity as assessed by electromyography (EMG) during 6MWT while wearing WRE
Time frame: within one month before start of WRE training
Change in energy expenditure as assessed by oxygen consumption during 10MWT while wearing WRE
Time frame: within one month before start of WRE training
Change in energy expenditure as assessed by oxygen consumption during 6MWT while wearing WRE
Time frame: within one month before start of WRE training
Change in gait kinematics as assessed by lower extremity joint excursion while wearing WRE
Time frame: within one month before start of WRE training
Change in gait kinematics as assessed by lower extremity joint angular velocities while wearing WRE
Time frame: within one month before start of WRE training
Change in H-reflex of soleus muscle as assessed by electromyography (EMG)
Time frame: within one week before start of WRE training, within 2 weeks after start of WRE training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Derived from this study: PubMed 33752175Zhu F, Kern M, Fowkes E, Afzal T, Contreras-Vidal JL, Francisco GE, Chang SH. Effects of an exoskeleton-assisted gait training on post-stroke lower-limb muscle coordination. J Neural Eng. 2021 Jun 4;18(4). doi: 10.1088/1741-2552/abf0d5.
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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.
Shuo-Hsiu Chang, PT, PhD 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 ReWalk, EKSO and REX in people with Complete Spinal Cord Injury and Incomplete Spinal Cord Injury, 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?
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: status not confirmed, as of the sponsor's last update on 23 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuo-Hsiu Chang, PT, PhD (713-799-7016, shuo-hsiu.chang@uth.tmc.edu), or a site near the patient. 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 without WRE (time frame: within one week before start of WRE training, within 2 weeks after start of WRE training). The study lists 8 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 NCT03057652, 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 23 May 2022.