Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training

Not Applicable

• Conditions: Complete Spinal Cord Injury; Incomplete Spinal Cord Injury; Acquired Brain Injury; Multiple Sclerosis
• Interventions: Device: ReWalk; Device: EKSO; Device: REX

• Registration Number: NCT03057652
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-15
• Study First Posted: 2017-02-20
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-23
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ReWalk, then EKSO, then REX	EKSO	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.
EKSO, then ReWalk, then REX	EKSO	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.
ReWalk, then REX, then EKSO	EKSO	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.
ReWalk, then REX, then EKSO	REX	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.
EKSO, then ReWalk, then REX	ReWalk	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.
EKSO, then REX, then ReWalk	EKSO	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.
ReWalk, then EKSO, then REX	ReWalk	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.
REX, then EKSO, then ReWalk	ReWalk	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.
ReWalk, then EKSO, then REX	REX	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.
ReWalk, then REX, then EKSO	ReWalk	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.
EKSO, then ReWalk, then REX	REX	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.
REX, then ReWalk, then EKSO	EKSO	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.
EKSO, then REX, then ReWalk	ReWalk	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.
EKSO, then REX, then ReWalk	REX	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.
REX, then EKSO, then ReWalk	REX	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.
REX, then ReWalk, then EKSO	ReWalk	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.
REX, then EKSO, then ReWalk	EKSO	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.
REX, then ReWalk, then EKSO	REX	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.

Primary Outcome Measures

Name	Time	Method
Change in over ground gait speed as assessed by the 10 Meter Walk Test without WRE	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 muscle activity as assessed by electromyography (EMG) during 10MWT without WRE	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 energy expenditure as assessed by oxygen consumption during 10MWT without WRE	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 gait kinematics as assessed by lower extremity joint excursion without WRE	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 walking endurance as assessed by the 6 Minute Walk Test without WRE	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 gait kinematics as assessed by lower extremity joint angular velocities without WRE	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 muscle activity as assessed by electromyography (EMG) during 6MWT without WRE	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 6MWT without WRE	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.

Secondary Outcome Measures

Name	Time	Method
Spasticity as assessed by the Modified Ashworth Scale (MAS)	within one month before start of WRE training	The Modified Ashworth Scale will be used to measure spasticity in lower limb.
Bone mineral density as assessed by whole body scan	within one month before start of WRE training	Subjects will undergo whole body bone scan according to standardized protocols.
Walking ability in ambulatory individuals with SC as assessed by Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI):	within one month before start of WRE training	Assesses functional walking ability in ambulatory individuals with SCI.
Confidence in performing various ambulatory activities as assessed by Activities-Specific Balance Confidence Scale	within one month before start of WRE training	Measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness. This is performed in ABI and MS population.
Change in muscle activity as assessed by electromyography (EMG) during 10MWT while wearing WRE	within one month before start of WRE training	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.
Change in energy expenditure as assessed by oxygen consumption during 10MWT while wearing WRE	within one month before 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. After WRE training has been completed, oxygen consumption will be assessed in subjects during the 10MWT while ambulating in the WRE.
Cognitive impairment as assessed by Folstein Mini Mental State Examination	within one month before start of WRE training	Folstein Mini Mental State Examination provides information about orientation, attention, learning, calculation, delayed recall, and construction.
Lower Extremity Muscle Strength as assessed by using a force gauge such as a handheld dynamometer	within one month before start of WRE training	We will measure lower extremity muscle strength using a force gauge such as a handheld dynamometer.
Motor recovery after stroke as assessed by Fugl-Meyer Assessment	within one month before start of WRE training	Evaluates and measures recovery in post-stroke hemiplegic individuals.
Over ground gait speed as assessed by the 10 Meter Walk Test while wearing WRE	within one month before start of WRE training	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.
Change in walking endurance as assessed by the 6 Minute Walk Test while wearing WRE	within one month before start of WRE training	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.
Range of motion for lower extremity joints as assessed by manual examination	within one month before start of WRE training	Range of joint motion of bilateral hip, knee and ankle joints. Subject will lie down on an examination table.
Amount of physical assistance needed for walking following paralysis resulted from SCI as assessed by Walking Index of Spinal Cord Injury (WISCI-II)	within one month before start of WRE training	This test is performed by SCI population.
Change in energy expenditure as assessed by oxygen consumption during 6MWT while wearing WRE	within one month before 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. After WRE training has been completed, oxygen consumption will be assessed in subjects during the 10MWT while ambulating in the WRE.
Stability during the maximum distance an individual can reach forward from a seated position as assessed by Modified Functional Reach (MFR)	within one month before start of WRE training	Assesses a patient's stability by measuring the maximum distance an individual can reach forward from a seated position.
User feedback as assessed by a questionnaire	within one month before start of WRE training	A questionnaire will be administered to allow participants to provide feedback regarding their experiences during intervention.
Change in muscle activity as assessed by electromyography (EMG) during 6MWT while wearing WRE	within one month before start of WRE training	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.
Change in gait kinematics as assessed by lower extremity joint excursion while wearing WRE	within one month before 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. After WRE training has been completed, subjects will be assessed while ambulating in the WRE.
Change in gait kinematics as assessed by lower extremity joint angular velocities while wearing WRE	within one month before 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. After WRE training has been completed, subjects will be assessed while ambulating in the WRE.
Change in H-reflex of soleus muscle as assessed by electromyography (EMG)	within one week before start of WRE training, within 2 weeks after start of WRE training	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.

Trial Locations

Locations (1)

TIRR Memorial Hermann; 🇺🇸 Houston, Texas, United States