Recruiting

Robotic Gait Training

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT03057652

Conditions

Complete Spinal Cord Injury

Incomplete Spinal Cord Injury

Acquired Brain Injury

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

ReWalk

EKSO

REX

Study Details

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.

Conditions

Complete Spinal Cord Injury

Incomplete Spinal Cord Injury

Acquired Brain Injury

Multiple Sclerosis

Study ID

NCT03057652

Start date

Mar, 2016

Status verified date

May, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ReWalk, then EKSO, then 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.

experimental: ReWalk, then REX, then 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.

experimental: EKSO, then ReWalk, then 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.

experimental: EKSO, then REX, then 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.

experimental: REX, then EKSO, then 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.

experimental: REX, then ReWalk, then 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.

Interventions

ReWalk

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.

EKSO

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.

REX

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.

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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Shuo-Hsiu Chang, PT, PhD

713-799-7016shuo-hsiu.chang@uth.tmc.edu

Ruta Paranjape, MS, CCRP

713-799-6976Ruta.Paranjape@uth.tmc.edu

Locations

TIRR Memorial Hermann

Recruiting

Houston, Texas, United States, 77030

Contacts

Shuo-Hsiu Chang, PT, PhD

713-799-7016Shuo-Hsiu.Chang@uth.tmc.edu

Marcie Kern, PT, MS

713-799-6995Marcie.Kern@memorialhermann.org

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

May 23, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2022-05-23.