Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training

The University of Texas Health Science Center, Houston75 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Complete Spinal Cord Injury Incomplete Spinal Cord Injury Acquired Brain Injury Multiple Sclerosis

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

TIRR Memorial Hermann

Houston, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

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.

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

The 6 Minute Walk Test (6MWT) assesses the distance walked in 6 minutes.

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

Surface EMG sensors will be placed on the skin of subjects' lower extremities during 10MWT.

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

Surface EMG sensors will be placed on the skin of subjects' lower extremities during 6MWT.

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

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.

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

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.

Central Contacts

Shuo-Hsiu Chang, PT, PhD

CONTACT

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

Ruta Paranjape, MS, CCRP

CONTACT

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

Data from ClinicalTrials.gov

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