Exoskeletal-assisted Walking to Improve Mobility, Bowel Function and Cardio-Metabolic Profiles in Persons With SCI

NCT02314221 | Completed Results

• 1 other identifier: SPU-14-031
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 3

Brief Summary

The primary objective of this study is to achieve successful walking skills using exoskeletal walking devices over the course of 36 sessions in 3 months at specific velocities and distances in people with chronic SCI who are wheelchair dependent for community mobility. The secondary objectives are to determine if this amount of exoskeletal walking is effective in improving bowel function and body composition in the same patient population. The exploratory objectives are to address additional questions concerning the retention or non-retention of the positive changes, the effects of the increased physical activity from this intervention on vagal tone, orthostatic tolerance, lipid profile, total testosterone, estradiol levels, and quality of life (QOL). A Phase III randomized clinical trial (RCT) will be performed using a crossover design and employing an exoskeletal-assisted walking intervention. The experimental arm will be compared to a usual activities (UA) arm, as the control, in 64 persons with chronic SCI (\>6 month post injury) who are wheelchair-dependent for outdoor mobility in the community. The WALK arm will consist of supervised exoskeletal-assisted walking training, three sessions per week (4-6 h/week) for 36 sessions for their second 12-week period. The UA arm will consist of identification of usual activities for each participant, encouragement to continue with these activities and attention by study team members throughout the 12-week UA arm. These activities will be recorded in a weekly log. The investigators hypotheses are that 1) this exoskeletal intervention will be successful in training ambulatory skills in this patient population, 2) the exoskeletal intervention will be better than a control group in improving body composition, bowel function, metabolic parameters and quality of life in the same population.

Conditions

Spinal Cord Injury; Paraplegia; Tetraplegia

Keywords

Exoskeletal-assisted walking

Outcome Measures

Primary Outcomes (4)

• 10meter Walk Test

  Number of participants completing the 10m Walk Test in less than 60 seconds

  Sessions 12 (1 month)

• 6min Walk Test

  Percentage of participants achieving distance of greater than 50m in 6min

  Session 12 (1 month)

• Timed-Up-and-Go Test (TUG)

  Percentage of participants completing the TUG in less than 120 seconds

  Session 12 (1 month)

• Number of Participants With Advanced Walking Skills

  By session 36, participants will have improved their ability to walk with or without minimal assistance, 1. 10m WT in ≤40 seconds (≥0.25 m/s) 2. 6min WT at a distance ≥80 m (≥0.22 m/s) 3. TUG in ≤90 seconds.

  Session 36 (Three months)

Secondary Outcomes (2)

• Bowel Function

  36 sessions (Three months)

• Body Fat Mass

  36 sessions (Three months)

Study Arms (2)

Exoskeletal-Assisted Walking (WALK)

EXPERIMENTAL

WALK first for 12 weeks (36 sessions)

Device: Exoskeletal-assisted walking (ReWalk, Ekso)

Usual Activities (UA)

NO INTERVENTION

Usual activities first for 12 weeks

Interventions

Exoskeletal-assisted walking (ReWalk, Ekso) DEVICE

The WALK arm will consist of supervised exoskeletal-assisted walking training, three sessions per week (4-6 h/week) for 36 sessions (12 weeks) and usual activities for their second 12-week period.

Also known as: ReWalk, Ekso

Exoskeletal-Assisted Walking (WALK)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, between 18-70 years old
• Traumatic or non-traumatic paraplegia \>6 months in duration
• SCI motor deficit at any level
• Unable to ambulate faster than 0.17 m/s on level ground with or without an assistive device and are wheelchair-dependent for community mobility
• Height 160 to 190 cm (63-75 in or 5'3" to 6'3" ft)
• Weight \<100 kg (\<220 lb)
• Able to hold the crutches
• Able to sign informed consent.

You may not qualify if:

• Diagnosis of neurological injury other than SCI including:
• Multiple sclerosis, Stroke, Cerebral Palsy, Amyotrophic lateral sclerosis, Traumatic Brain injury, Spina bifida, Parkinson's disease, or
• Severe concurrent medical disease, illness or condition
• Recent lower extremity fracture within the past 2 years
• DXA results indicating a t-score below -3.5 at the femoral neck or the total proximal femur bone and knee BMD \<0.60 gm/cm2
• Diagnosis of heterotropic ossification of the lower extremities which affect range of motion or proper measurement of BMD measurements
• Significant contractures defined as flexion contracture limited to 35º at the hip and 20º at the knee
• Untreated hypertension (SBP\>140, DBP\>90 mmHg)
• Symptomatic orthostatic hypotension with standing that does not resolve after attempts at upright posture that were made over several days, and standing by the participant is deemed to pose a health risk, as determined by a physician, because of symptomatic orthostatic hypotension
• Systemic or peripheral infection
• Atherosclerosis, congestive heart failure, or history of myocardial infarction;
• Trunk and/or lower extremity pressure ulcers
• Severe spasticity (defined by an Ashworth score of \>4.0 or clinical impression of the study physician or physical therapist)
• Significant contractures defined as flexion contracture limited to 25º at the hip and knee
• Diagnosis of heterotropic ossification of the lower extremities which affect range of motion or proper measurement of BMD measurements

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center: lead

Study Sites (3)

Univerity of Maryland rehabilitation and Orthopaedic Institute (UMROI)

Baltimore, Maryland, 21201, United States

Location

Kessler Foundation Research Center (KFRC)

West Orange, New Jersey, 07052, United States

Location

James J Peteres VA Medical Center

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia; Quadriplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ann M. Spungen, EdD
• Organization: VA RR&D National Center for the Medical Consequences of Spinal Cord Injury

ann.spungen@va.gov

718-584-9000

Study Officials

• Ann M Spungen, EdD

  James J Peters VAMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: VA Research Scientist

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 11, 2014
• Study Start: February 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: June 1, 2020
• Last Updated: May 16, 2025
• Results First Posted: May 16, 2025

Record last verified: 2025-05

Locations

US (3)