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

Completed · Not applicable

Conditions studied: Spinal Cord Injury, Paraplegia, Tetraplegia

In brief

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.

Key facts

Study ID: NCT02314221
Run by: James J. Peters Veterans Affairs Medical Center
People needed: 73
Starts: 2015-02-01
Expected to finish: 2020-06-01
Last updated by the study team: 2025-05-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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
Other neurological condition that the study physician considers in his/her clinical judgment to be exclusionary
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
Psychopathology documentation in the medical record or history of that may conflict with study objectives
Pregnancy and/or lactating females
Brain injury with score on mini-mental status examination less than 26
Diagnosis of coronary artery disease that precludes moderate to intense exercise
Deep vein thromboses in lower extremities of less than 6 months duration
Other illness, that the study physician considers in his/her clinical judgment to be exclusionary.

Where it is running

Univerity of Maryland rehabilitation and Orthopaedic Institute (UMROI) — Baltimore, Maryland, United States
Kessler Foundation Research Center (KFRC) — West Orange, New Jersey, United States
James J Peteres VA Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.