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NCT02314221 · ClinicalTrials.gov registry record · NA
Exoskeletal-assisted Walking to Improve Mobility, Bowel Function and Cardio-Metabolic Profiles in Persons With SCI
A NA study, sponsored by James J. Peters Veterans Affairs Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 73
- Enrollment target
NCT02314221 is a NA study that has completed, run by James J. Peters Veterans Affairs Medical Center. The registered enrollment target is 73 participants.
The verdict
NCT02314221, a NA study, has completed, sponsored by James J. Peters Veterans Affairs Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 73 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Exoskeletal-assisted walking (ReWalk, Ekso)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2015-02 |
| Est. Completion | 2020-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02314221
The ClinicalTrials.gov registry entry for NCT02314221 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is James J. Peters Veterans Affairs Medical Center, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Exoskeletal-assisted walking (ReWalk, Ekso) is the first listed.
NCT02314221 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02314221 about?
NCT02314221 is a clinical study titled "Exoskeletal-assisted Walking to Improve Mobility, Bowel Function and Cardio-Metabolic Profiles in Persons With SCI". 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 t...
What is the current status of trial NCT02314221?
This trial is currently completed. It is a NA study. The enrollment target is 73 participants. The study started on 2015-02. Estimated completion is 2020-06.
What interventions are being tested in trial NCT02314221?
The interventions under investigation include: Exoskeletal-assisted walking (ReWalk, Ekso) (DEVICE).
Who is sponsoring clinical trial NCT02314221?
This trial is sponsored by James J. Peters Veterans Affairs Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
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