Trial Outcomes & Findings for Exoskeletal-assisted Walking to Improve Mobility, Bowel Function and Cardio-Metabolic Profiles in Persons With SCI (NCT NCT02314221)

NCT ID: NCT02314221

Last Updated: 2025-05-16

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

73 participants

Primary outcome timeframe

Sessions 12 (1 month)

Results posted on

2025-05-16

Participant Flow

The study physicians at each site are the primary source of identifying potential human subjects for this study. In-services were provided to educate other staff physicians about this study so that they could refer eligible participants. Additionally, IRB-approved flyers and brochures were distributed. Referred subjects, as well as potential subjects responding to IRB approved advertisements and articles in lay publications, are informed about the details and eligibility for the study.

Participants withdrew with schedule conflicts.

Participant milestones

Participant milestones
Measure	Exoskeletal-Assisted Walking (EAW)-Usual Activities (UA) WALK first for 12 weeks (36 sessions) 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. Crossover to Usual Activities (UA) for 12 weeks.	Usual Activities (UA)-Exoskeletal-Assisted Walking (EAW) Usual activities first for 12 weeks. Crossover to EAW for 12 weeks (36 sessions)
Overall Study STARTED	38	35
Overall Study COMPLETED	26	24
Overall Study NOT COMPLETED	12	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One participant did not complete one of assessments.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exoskeletal-Assisted Walking (EAW) - UA n=24 Participants WALK first for 12 weeks (36 sessions) 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. Crossover to UA for 12 weeks.	Usual Activities (UA) - EAW n=25 Participants Usual activities first for 12 weeks Crossover to EAW for 12 weeks (36 sessions)	Total n=49 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants • One participant did not complete one of assessments.	0 Participants n=107 Participants • One participant did not complete one of assessments.	0 Participants n=206 Participants • One participant did not complete one of assessments.
Age, Categorical Between 18 and 65 years	23 Participants n=99 Participants • One participant did not complete one of assessments.	23 Participants n=107 Participants • One participant did not complete one of assessments.	46 Participants n=206 Participants • One participant did not complete one of assessments.
Age, Categorical >=65 years	1 Participants n=99 Participants • One participant did not complete one of assessments.	2 Participants n=107 Participants • One participant did not complete one of assessments.	3 Participants n=206 Participants • One participant did not complete one of assessments.
Age, Continuous	38.0 years STANDARD_DEVIATION 13.6 • n=99 Participants	38.9 years STANDARD_DEVIATION 15.0 • n=107 Participants	38.4 years STANDARD_DEVIATION 14.2 • n=206 Participants
Sex: Female, Male Female	7 Participants n=99 Participants • One participant did not complete one of assessments.	4 Participants n=107 Participants • One participant did not complete one of assessments.	11 Participants n=206 Participants • One participant did not complete one of assessments.
Sex: Female, Male Male	17 Participants n=99 Participants • One participant did not complete one of assessments.	21 Participants n=107 Participants • One participant did not complete one of assessments.	38 Participants n=206 Participants • One participant did not complete one of assessments.
Race/Ethnicity, Customized American Indian or Alaskan Native	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Race/Ethnicity, Customized Black, not of Hispanic origin	5 Participants n=99 Participants	10 Participants n=107 Participants	15 Participants n=206 Participants
Race/Ethnicity, Customized Hispanic	4 Participants n=99 Participants	5 Participants n=107 Participants	9 Participants n=206 Participants
Race/Ethnicity, Customized White, not of Hispanic origin	10 Participants n=99 Participants	10 Participants n=107 Participants	20 Participants n=206 Participants
Race/Ethnicity, Customized Other	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Region of Enrollment United States	24 participants n=99 Participants	25 participants n=107 Participants	50 participants n=206 Participants

PRIMARY outcome

Timeframe: Sessions 12 (1 month)

Population: This study employed a randomized crossover design with an EAW intervention arm and an UA arm. The order of intervention was different for Group 1 and 2. All participants received EAW the entire course of the study and the outcome was from EAW phase.

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

Outcome measures

Outcome measures
Measure	Exoskeletal-Assisted Walking (EAW)-Usual Activities (UA) n=52 Participants WALK first for 12 weeks (36 sessions) 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. Crossover to Usual Activities (UA) for 12 weeks.	Usual Activities (UA)-Exoskeletal-Assisted Walking (EAW) n=48 Participants Usual activities first for 12 weeks. Crossover to EAW for 12 weeks (36 sessions)
10meter Walk Test	46 Participants	48 Participants

PRIMARY outcome

Timeframe: Session 12 (1 month)

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

Outcome measures

Outcome measures
Measure	Exoskeletal-Assisted Walking (EAW)-Usual Activities (UA) n=52 Participants WALK first for 12 weeks (36 sessions) 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. Crossover to Usual Activities (UA) for 12 weeks.	Usual Activities (UA)-Exoskeletal-Assisted Walking (EAW) n=48 Participants Usual activities first for 12 weeks. Crossover to EAW for 12 weeks (36 sessions)
6min Walk Test	46 Participants	48 Participants

PRIMARY outcome

Timeframe: Session 12 (1 month)

Percentage of participants completing the TUG in less than 120 seconds

Outcome measures

Outcome measures
Measure	Exoskeletal-Assisted Walking (EAW)-Usual Activities (UA) n=52 Participants WALK first for 12 weeks (36 sessions) 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. Crossover to Usual Activities (UA) for 12 weeks.	Usual Activities (UA)-Exoskeletal-Assisted Walking (EAW) n=48 Participants Usual activities first for 12 weeks. Crossover to EAW for 12 weeks (36 sessions)
Timed-Up-and-Go Test (TUG)	50 Participants	48 Participants

PRIMARY outcome

Timeframe: Session 36 (Three months)

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.

Outcome measures

Outcome measures
Measure	Exoskeletal-Assisted Walking (EAW)-Usual Activities (UA) n=52 Participants WALK first for 12 weeks (36 sessions) 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. Crossover to Usual Activities (UA) for 12 weeks.	Usual Activities (UA)-Exoskeletal-Assisted Walking (EAW) n=48 Participants Usual activities first for 12 weeks. Crossover to EAW for 12 weeks (36 sessions)
Number of Participants With Advanced Walking Skills 10MWT	42 Participants	44 Participants
Number of Participants With Advanced Walking Skills 6MWT	40 Participants	44 Participants
Number of Participants With Advanced Walking Skills TUG	46 Participants	48 Participants

SECONDARY outcome

Timeframe: 36 sessions (Three months)

To improve bowel function as measured by one of established survey instruments. The effect of exoskeletal-assisted walking on bowel function was assessed using the short-form item bank for Bowel Management Difficulties from the SCI-Quality of Life instrument (SCI-QOL). It was performed three times: at baseline, at crossover, and after the second arm for both the UA and the EAW group. The Bowel Management Difficulties item bank from the SCI-QOL instrument consisted of 26 items scored on a five-point Likert scale (possible score range 26-130). The SCI-QOL scores were standardized on a T-metric, according to a previously published T-score conversion table for SCI-QOL Bowel Management Difficulties. Lower scores indicate greater satisfaction with management. Items included such statements as the following: Bowel accidents limited my independence; I worried about performing my bowel program; and I was frustrated by repeated bowel accidents. Validation of the SCI-QOL has been performed.

Outcome measures

Outcome measures
Measure	Exoskeletal-Assisted Walking (EAW)-Usual Activities (UA) n=49 Participants WALK first for 12 weeks (36 sessions) 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. Crossover to Usual Activities (UA) for 12 weeks.	Usual Activities (UA)-Exoskeletal-Assisted Walking (EAW) n=49 Participants Usual activities first for 12 weeks. Crossover to EAW for 12 weeks (36 sessions)
Bowel Function Post	48.4 score on a scale Standard Deviation 9.2	49.3 score on a scale Standard Deviation 9.2
Bowel Function Pre	49.7 score on a scale Standard Deviation 8.7	50.8 score on a scale Standard Deviation 8.6

SECONDARY outcome

Timeframe: 36 sessions (Three months)

Measurement of total body fat mass (kg) by DXA was performed three times: Pre, Mid, and Post. Group 1: Pre-testing - EAW - Mid-testing - UA - Post-testing Group 2: Pre-testing - UA - Mid-testing - EAW - Post-testing Total body fat mass is measured to observe decreasing total body fat mass by three months of exoskeletal-assisted walking. Outcome measure data table shows pre-post of different phases.

Outcome measures

Outcome measures
Measure	Exoskeletal-Assisted Walking (EAW)-Usual Activities (UA) n=50 Participants WALK first for 12 weeks (36 sessions) 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. Crossover to Usual Activities (UA) for 12 weeks.	Usual Activities (UA)-Exoskeletal-Assisted Walking (EAW) n=49 Participants Usual activities first for 12 weeks. Crossover to EAW for 12 weeks (36 sessions)
Body Fat Mass Total Body Fat Mass - Pre	23.6 kg Standard Deviation 9.6	22.4 kg Standard Deviation 9.5
Body Fat Mass Total Body Fat Mass - Post	22.1 kg Standard Deviation 9.6	22.8 kg Standard Deviation 9.8

Adverse Events

Exoskeletal-Assisted Walking (EAW)

Serious events: 7 serious events

Other events: 24 other events

Deaths: 0 deaths

Usual Activities (UA)

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Exoskeletal-Assisted Walking (EAW) n=52 participants at risk 36 total sessions of Exoskeletal-assisted walking (ReWalk, Ekso). Each session consisted of supervised exoskeletal-assisted walking training, three sessions per week (4-6 h/week, 12 total weeks).	Usual Activities (UA) n=48 participants at risk Usual activities, control, standard of living, no Exoskeletal-assisted walking.
Respiratory, thoracic and mediastinal disorders Shortness of breath	1.9% 1/52 • Number of events 1 • The adverse events were collected through study completion, an average of 3 months of EAW. An adverse event (AE) is any untoward physical or psychological occurrence in a human subject participating in research. An AE can be favorable and unintended event, including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE is considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent such an outcome.	0.00% 0/48 • The adverse events were collected through study completion, an average of 3 months of EAW. An adverse event (AE) is any untoward physical or psychological occurrence in a human subject participating in research. An AE can be favorable and unintended event, including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE is considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent such an outcome.
Musculoskeletal and connective tissue disorders Fall During Transportation	1.9% 1/52 • Number of events 1 • The adverse events were collected through study completion, an average of 3 months of EAW. An adverse event (AE) is any untoward physical or psychological occurrence in a human subject participating in research. An AE can be favorable and unintended event, including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE is considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent such an outcome.	0.00% 0/48 • The adverse events were collected through study completion, an average of 3 months of EAW. An adverse event (AE) is any untoward physical or psychological occurrence in a human subject participating in research. An AE can be favorable and unintended event, including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE is considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent such an outcome.
Psychiatric disorders Emotional Distress	1.9% 1/52 • Number of events 1 • The adverse events were collected through study completion, an average of 3 months of EAW. An adverse event (AE) is any untoward physical or psychological occurrence in a human subject participating in research. An AE can be favorable and unintended event, including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE is considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent such an outcome.	0.00% 0/48 • The adverse events were collected through study completion, an average of 3 months of EAW. An adverse event (AE) is any untoward physical or psychological occurrence in a human subject participating in research. An AE can be favorable and unintended event, including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE is considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent such an outcome.
Blood and lymphatic system disorders Low Blood Pressure	1.9% 1/52 • Number of events 1 • The adverse events were collected through study completion, an average of 3 months of EAW. An adverse event (AE) is any untoward physical or psychological occurrence in a human subject participating in research. An AE can be favorable and unintended event, including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE is considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent such an outcome.	0.00% 0/48 • The adverse events were collected through study completion, an average of 3 months of EAW. An adverse event (AE) is any untoward physical or psychological occurrence in a human subject participating in research. An AE can be favorable and unintended event, including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE is considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent such an outcome.
Nervous system disorders Numbness in both arms	1.9% 1/52 • Number of events 1 • The adverse events were collected through study completion, an average of 3 months of EAW. An adverse event (AE) is any untoward physical or psychological occurrence in a human subject participating in research. An AE can be favorable and unintended event, including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE is considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent such an outcome.	0.00% 0/48 • The adverse events were collected through study completion, an average of 3 months of EAW. An adverse event (AE) is any untoward physical or psychological occurrence in a human subject participating in research. An AE can be favorable and unintended event, including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE is considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent such an outcome.
Renal and urinary disorders Urinary Tract Infection	7.7% 4/52 • Number of events 4 • The adverse events were collected through study completion, an average of 3 months of EAW. An adverse event (AE) is any untoward physical or psychological occurrence in a human subject participating in research. An AE can be favorable and unintended event, including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE is considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent such an outcome.	2.1% 1/48 • Number of events 1 • The adverse events were collected through study completion, an average of 3 months of EAW. An adverse event (AE) is any untoward physical or psychological occurrence in a human subject participating in research. An AE can be favorable and unintended event, including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE is considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent such an outcome.
Musculoskeletal and connective tissue disorders Ankle Fracture	1.9% 1/52 • Number of events 1 • The adverse events were collected through study completion, an average of 3 months of EAW. An adverse event (AE) is any untoward physical or psychological occurrence in a human subject participating in research. An AE can be favorable and unintended event, including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE is considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent such an outcome.	0.00% 0/48 • The adverse events were collected through study completion, an average of 3 months of EAW. An adverse event (AE) is any untoward physical or psychological occurrence in a human subject participating in research. An AE can be favorable and unintended event, including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE is considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent such an outcome.
Gastrointestinal disorders Bowel Complications	1.9% 1/52 • Number of events 1 • The adverse events were collected through study completion, an average of 3 months of EAW. An adverse event (AE) is any untoward physical or psychological occurrence in a human subject participating in research. An AE can be favorable and unintended event, including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE is considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent such an outcome.	0.00% 0/48 • The adverse events were collected through study completion, an average of 3 months of EAW. An adverse event (AE) is any untoward physical or psychological occurrence in a human subject participating in research. An AE can be favorable and unintended event, including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE is considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent such an outcome.

Other adverse events

Other adverse events
Measure	Exoskeletal-Assisted Walking (EAW) n=52 participants at risk 36 total sessions of Exoskeletal-assisted walking (ReWalk, Ekso). Each session consisted of supervised exoskeletal-assisted walking training, three sessions per week (4-6 h/week, 12 total weeks).	Usual Activities (UA) n=48 participants at risk Usual activities, control, standard of living, no Exoskeletal-assisted walking.
Musculoskeletal and connective tissue disorders Skin Abrasion/Bruising	28.8% 15/52 • Number of events 27 • The adverse events were collected through study completion, an average of 3 months of EAW. An adverse event (AE) is any untoward physical or psychological occurrence in a human subject participating in research. An AE can be favorable and unintended event, including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE is considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent such an outcome.	22.9% 11/48 • Number of events 12 • The adverse events were collected through study completion, an average of 3 months of EAW. An adverse event (AE) is any untoward physical or psychological occurrence in a human subject participating in research. An AE can be favorable and unintended event, including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE is considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent such an outcome.
Musculoskeletal and connective tissue disorders Fall	9.6% 5/52 • Number of events 6 • The adverse events were collected through study completion, an average of 3 months of EAW. An adverse event (AE) is any untoward physical or psychological occurrence in a human subject participating in research. An AE can be favorable and unintended event, including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE is considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent such an outcome.	6.2% 3/48 • Number of events 3 • The adverse events were collected through study completion, an average of 3 months of EAW. An adverse event (AE) is any untoward physical or psychological occurrence in a human subject participating in research. An AE can be favorable and unintended event, including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE is considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent such an outcome.
Renal and urinary disorders Urinary Tract Infection	7.7% 4/52 • Number of events 4 • The adverse events were collected through study completion, an average of 3 months of EAW. An adverse event (AE) is any untoward physical or psychological occurrence in a human subject participating in research. An AE can be favorable and unintended event, including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE is considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent such an outcome.	2.1% 1/48 • Number of events 1 • The adverse events were collected through study completion, an average of 3 months of EAW. An adverse event (AE) is any untoward physical or psychological occurrence in a human subject participating in research. An AE can be favorable and unintended event, including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE is considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent such an outcome.

Additional Information

Ann M. Spungen, EdD

VA RR&D National Center for the Medical Consequences of Spinal Cord Injury

Phone: 718-584-9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place