Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training

NCT03057652 | Unknown FDA Device

• 1 other identifier: HSC-MS-15-0923
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  within one month before start of WRE training

• Cognitive impairment as assessed by Folstein Mini Mental State Examination

  within one month before start of WRE training

• Lower Extremity Muscle Strength as assessed by using a force gauge such as a handheld dynamometer

  within one month before start of WRE training

• Spasticity as assessed by the Modified Ashworth Scale (MAS)

  within one month before start of WRE training

• Range of motion for lower extremity joints as assessed by manual examination

  within one month before start of WRE training

Study Arms (6)

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.

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.

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.

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.

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.

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.

Device: ReWalk; Device: EKSO; Device: REX

Interventions

ReWalk DEVICE

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, 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

EKSO DEVICE

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.

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

REX DEVICE

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Male or non-pregnant female
• ≥18 years of age

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

TIRR Memorial Hermann

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 33752175 DERIVED

MeSH Terms

Conditions

Brain Injuries; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Shuo-Hsiu Chang, PT, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 20, 2017
• Study Start: March 1, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 23, 2022

Record last verified: 2022-05

Locations

US (1)