Exoskeletal-assisted Walking to Improve Mobility, Bowel Function and Cardio-Metabolic Profiles in Persons With SCI (EAWSCI)
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Purpose
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.
| Condition | Intervention |
|---|---|
| Spinal Cord Injury Paraplegia Tetraplegia | Device: Exoskeletal-assisted walking (ReWalk, Ekso) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Crossover Clinical Trial of Exoskeletal-assisted Walking to Improve Mobility, Bowel Function and Cardio-Metabolic Profiles in Persons With SCI |
- 10meter Walk Test [ Time Frame: Sessions 12 (1 month) ]Number of participants completing the 10m Walk Test in less than 60 seconds
- 6min Walk Test [ Time Frame: Session 12 (1 month) ]Percentage of participants achieving distance of greater than 50m in 6min
- Timed-Up-and-Go Test (TUG) [ Time Frame: Session 12 (1 month) ]Percentage of participants completing the TUG in less than 120 seconds
- Advanced Walking Skills [ Time Frame: Session 36 (Three months) ]By session 36, participants will have improved their ability to walk with or without minimal assistance
- Bowel Function [ Time Frame: 36 sessions (Three months) ]To improve bowel function as measured by established survey instruments
- Total body fat mass [ Time Frame: 36 sessions (Three months) ]To reduce total body fat mass and percent as measured by DXA.
| Estimated Enrollment: | 64 |
| Study Start Date: | February 2015 |
| Estimated Study Completion Date: | January 2019 |
| Estimated Primary Completion Date: | July 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Exoskeletal-Assisted Walking (WALK)
WALK first for 12 weeks (36 sessions)
|
Device: Exoskeletal-assisted walking (ReWalk, Ekso)
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.
Other Names:
|
|
No Intervention: Usual Activities (UA)
Usual activities first for 12 weeks
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT02314221
| Contact: Manuel Avedissian, MD | 718-584-9000 ext 5426 | manuel.avedissian@va.gov | |
| Contact: Pierre K Asselin, MS | 718-584-9000 ext 3124 | pierre.asselin@va.gov |
| United States, Maryland | |
| Univerity of Maryland rehabilitation and Orthopaedic Institute (UMROI) | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Leigh Casey 410-448-6773 lcasey@umm.edu | |
| Principal Investigator: Peter Gorman, MD | |
| United States, New Jersey | |
| Kessler Foundation Research Center (KFRC) | Recruiting |
| West Orange, New Jersey, United States, 07052 | |
| Contact: Leighann Martinez 973-324-3557 LMartinez@kesslerfoundation.org | |
| Principal Investigator: Gail F. Forrest, PhD | |
| United States, New York | |
| James J Peteres VA Medical Center | Recruiting |
| Bronx, New York, United States, 10468 | |
| Contact: Manuel Avedissian, MD 718-584-9000 ext 5426 manuel.avedissian@va.gov | |
| Principal Investigator: Ann M Spungen, EdD | |
| Principal Investigator: | Ann M Spungen, EdD | James J Peters VAMC |
More Information
| Responsible Party: | Ann M. Spungen, EdD, VA Research Scientist, James J. Peters Veterans Affairs Medical Center |
| ClinicalTrials.gov Identifier: | NCT02314221 History of Changes |
| Other Study ID Numbers: |
SPU-14-031 |
| Study First Received: | December 2, 2014 |
| Last Updated: | September 1, 2015 |
Keywords provided by Ann M. Spungen, EdD, James J. Peters Veterans Affairs Medical Center:
|
Exoskeletal-assisted walking |
Additional relevant MeSH terms:
|
Spinal Cord Injuries Quadriplegia Paraplegia Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases |
Trauma, Nervous System Wounds and Injuries Paralysis Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on July 17, 2017


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