Trial Outcomes & Findings for Effects of Exoskeleton-Assisted Gait Training on Bone Health and Quality of Life (NCT NCT02533713)
NCT ID: NCT02533713
Last Updated: 2026-09-02
Results Overview
Assessed by finite element analysis of quantitative CT scan (QCT) of the knee, values indicate measured epiphysis compressive strength index
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
61 participants
Primary outcome timeframe
Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)
Results posted on
2026-09-02
Participant Flow
1 participant consented and enrolled into the study but did not progress to randomization or complete any study activities (e.g. secondary screening, study testing).
Participant milestones
| Measure |
Immediate Gait Training
Participants assigned to this arm will begin Exoskeleton assisted gait training right away and will continue training for the first 6 months of the study.
|
Delayed Gait Training
Participants assigned to this arm will not gait train for 6 months. They will engage in Exoskeleton assisted gait training for the last 6 months of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
27
|
|
Overall Study
COMPLETED
|
13
|
6
|
|
Overall Study
NOT COMPLETED
|
20
|
21
|
Reasons for withdrawal
| Measure |
Immediate Gait Training
Participants assigned to this arm will begin Exoskeleton assisted gait training right away and will continue training for the first 6 months of the study.
|
Delayed Gait Training
Participants assigned to this arm will not gait train for 6 months. They will engage in Exoskeleton assisted gait training for the last 6 months of the study.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
|
Overall Study
Protocol Violation
|
11
|
13
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
|
Overall Study
Did not progress at baseline
|
4
|
0
|
Baseline Characteristics
18 out of 33 immediate and 10 out of 27 delayed gait training participants passed secondary level screening for QCT scan of the knee and tibial stiffness analysis.
Baseline characteristics by cohort
| Measure |
Immediate Gait Training
n=33 Participants
Participants assigned to this arm will begin Exoskeleton assisted gait training right away and will continue training for the first 6 months of the study.
|
Delayed Gait Training
n=27 Participants
Participants assigned to this arm will not gait train for 6 months. They will engage in Exoskeleton assisted gait training for the last 6 months of the study.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.8 years
STANDARD_DEVIATION 13.7 • n=33 Participants
|
37.8 years
STANDARD_DEVIATION 13.6 • n=27 Participants
|
41.1 years
STANDARD_DEVIATION 13.8 • n=60 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=33 Participants
|
8 Participants
n=27 Participants
|
14 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=33 Participants
|
19 Participants
n=27 Participants
|
46 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=33 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=33 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=33 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=33 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=33 Participants
|
14 Participants
n=27 Participants
|
29 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=33 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=33 Participants
|
11 Participants
n=27 Participants
|
25 Participants
n=60 Participants
|
|
Tibial Stiffness
|
0.20 g(^2)/cm(^4)
STANDARD_DEVIATION 0.18 • n=18 Participants • 18 out of 33 immediate and 10 out of 27 delayed gait training participants passed secondary level screening for QCT scan of the knee and tibial stiffness analysis.
|
0.18 g(^2)/cm(^4)
STANDARD_DEVIATION 0.15 • n=10 Participants • 18 out of 33 immediate and 10 out of 27 delayed gait training participants passed secondary level screening for QCT scan of the knee and tibial stiffness analysis.
|
0.19 g(^2)/cm(^4)
STANDARD_DEVIATION 0.16 • n=28 Participants • 18 out of 33 immediate and 10 out of 27 delayed gait training participants passed secondary level screening for QCT scan of the knee and tibial stiffness analysis.
|
PRIMARY outcome
Timeframe: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)Assessed by finite element analysis of quantitative CT scan (QCT) of the knee, values indicate measured epiphysis compressive strength index
Outcome measures
| Measure |
Immediate Gait Training
n=13 Participants
Participants assigned to this arm will begin Exoskeleton assisted gait training right away and will continue training for the first 6 months of the study.
|
Delayed Gait Training
n=6 Participants
Participants assigned to this arm will not gait train for 6 months. They will engage in Exoskeleton assisted gait training for the last 6 months of the study.
|
|---|---|---|
|
Change in Tibial Stiffness
Pre Gait Training
|
0.20 g(^2)/cm(^4)
Standard Deviation 0.12
|
0.25 g(^2)/cm(^4)
Standard Deviation 0.15
|
|
Change in Tibial Stiffness
Post Gait Training
|
0.22 g(^2)/cm(^4)
Standard Deviation 0.15
|
0.27 g(^2)/cm(^4)
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)Assessed by quantitative CT scan (QCT) of the knee, values indicate measured epiphysis cortical bone volume
Outcome measures
| Measure |
Immediate Gait Training
n=13 Participants
Participants assigned to this arm will begin Exoskeleton assisted gait training right away and will continue training for the first 6 months of the study.
|
Delayed Gait Training
n=6 Participants
Participants assigned to this arm will not gait train for 6 months. They will engage in Exoskeleton assisted gait training for the last 6 months of the study.
|
|---|---|---|
|
Change in Bone Volume
Pre Gait Training
|
4.7 cm(^3)
Standard Deviation 2.49
|
4.53 cm(^3)
Standard Deviation 2.02
|
|
Change in Bone Volume
Post Gait Training
|
4.75 cm(^3)
Standard Deviation 2.55
|
4.86 cm(^3)
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)Assessed by Patient Health Questionnaire-9 (PHQ-9) contains 9 items, with total scores ranging from 0 (none to minimal depression) to 27 (severe depression).
Outcome measures
| Measure |
Immediate Gait Training
n=13 Participants
Participants assigned to this arm will begin Exoskeleton assisted gait training right away and will continue training for the first 6 months of the study.
|
Delayed Gait Training
n=6 Participants
Participants assigned to this arm will not gait train for 6 months. They will engage in Exoskeleton assisted gait training for the last 6 months of the study.
|
|---|---|---|
|
Change in Mood
Pre Gait Training
|
5.53 scores on a scale
Standard Deviation 4.23
|
3.16 scores on a scale
Standard Deviation 3.12
|
|
Change in Mood
Post Gait Training
|
4.23 scores on a scale
Standard Deviation 3.37
|
7.83 scores on a scale
Standard Deviation 5.84
|
SECONDARY outcome
Timeframe: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)Assessed by International Spinal Cord Injury Basic Pain Data Set, standardize the collection and reporting of pain and its interference in the SCI population. A composite score of 3 items on pain interference, with total score ranging from 0 (pain has no interference) to 10 (pain has extreme interference).
Outcome measures
| Measure |
Immediate Gait Training
n=13 Participants
Participants assigned to this arm will begin Exoskeleton assisted gait training right away and will continue training for the first 6 months of the study.
|
Delayed Gait Training
n=6 Participants
Participants assigned to this arm will not gait train for 6 months. They will engage in Exoskeleton assisted gait training for the last 6 months of the study.
|
|---|---|---|
|
Change in Pain
Pre Gait Training
|
7.61 scores on a scale
Standard Deviation 5.34
|
9.83 scores on a scale
Standard Deviation 7.6
|
|
Change in Pain
Post Gait Training
|
7.23 scores on a scale
Standard Deviation 7.07
|
8.50 scores on a scale
Standard Deviation 7.14
|
SECONDARY outcome
Timeframe: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)Population: 3 participants (2 immediate gait training, 1 delayed gait training) were not able to complete MRI imaging for safety reason, so no MRI imaging analysis could be performed.
Assessed by brain magnetic resonance imaging (MRI), values indicate measured cortical activity from right caudate to right central operculum and insular. The reported metric is the beta-estimate of the connectivity between the caudate (seed region) and the right central operculum. Higher beta-estimate equate to more connectivity between the two regions.
Outcome measures
| Measure |
Immediate Gait Training
n=11 Participants
Participants assigned to this arm will begin Exoskeleton assisted gait training right away and will continue training for the first 6 months of the study.
|
Delayed Gait Training
n=5 Participants
Participants assigned to this arm will not gait train for 6 months. They will engage in Exoskeleton assisted gait training for the last 6 months of the study.
|
|---|---|---|
|
Change in Cortical Activity
Pre Gait Training
|
-0.04 beta estimate of MRI connectity
Standard Deviation 0.11
|
-0.03 beta estimate of MRI connectity
Standard Deviation 0.13
|
|
Change in Cortical Activity
Post Gait Training
|
-0.04 beta estimate of MRI connectity
Standard Deviation 0.08
|
0.12 beta estimate of MRI connectity
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)Assessed by psychological domain of the World Health Organization Quality-of-Life Scale (WHOQOL-BREF), Domain 1 reports on the physical health, with raw score ranging from 7-35, and transformed scores to a 0-100 point interval. Higher scores (raw=35, transformed=100) correspond to greater perceived quality of life pertaining to physical health.
Outcome measures
| Measure |
Immediate Gait Training
n=13 Participants
Participants assigned to this arm will begin Exoskeleton assisted gait training right away and will continue training for the first 6 months of the study.
|
Delayed Gait Training
n=6 Participants
Participants assigned to this arm will not gait train for 6 months. They will engage in Exoskeleton assisted gait training for the last 6 months of the study.
|
|---|---|---|
|
Change in Health-related Quality of Life, Domain 1
Pre Gait Training
|
62.23 scores on a scale
Standard Deviation 14.1
|
67.83 scores on a scale
Standard Deviation 8.25
|
|
Change in Health-related Quality of Life, Domain 1
Post Gait Training
|
67.53 scores on a scale
Standard Deviation 12.95
|
58.33 scores on a scale
Standard Deviation 15.3
|
SECONDARY outcome
Timeframe: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)Assessed by psychological domain of the World Health Organization Quality-of-Life Scale (WHOQOL-BREF), Domain 2 reports on the psychological health, with raw score ranging from 6-30, and transformed scores to a 0-100 point interval. Higher scores (raw=30, transformed=100) correspond to greater perceived quality of life pertaining to psychological health.
Outcome measures
| Measure |
Immediate Gait Training
n=13 Participants
Participants assigned to this arm will begin Exoskeleton assisted gait training right away and will continue training for the first 6 months of the study.
|
Delayed Gait Training
n=6 Participants
Participants assigned to this arm will not gait train for 6 months. They will engage in Exoskeleton assisted gait training for the last 6 months of the study.
|
|---|---|---|
|
Change in Health-related Quality of Life, Domain 2
Pre Gait Training
|
62.53 scores on a scale
Standard Deviation 18.09
|
66.66 scores on a scale
Standard Deviation 18.43
|
|
Change in Health-related Quality of Life, Domain 2
Post Gait Training
|
60.53 scores on a scale
Standard Deviation 17.92
|
60.5 scores on a scale
Standard Deviation 21.81
|
SECONDARY outcome
Timeframe: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)Assessed by psychological domain of the World Health Organization Quality-of-Life Scale (WHOQOL-BREF), Domain 3 reports on the social relationship, with raw score ranging from 3-15, and transformed scores to a 0-100 point interval. Higher scores (raw=15, transformed=100) correspond to greater perceived quality of life pertaining to social relationship.
Outcome measures
| Measure |
Immediate Gait Training
n=13 Participants
Participants assigned to this arm will begin Exoskeleton assisted gait training right away and will continue training for the first 6 months of the study.
|
Delayed Gait Training
n=6 Participants
Participants assigned to this arm will not gait train for 6 months. They will engage in Exoskeleton assisted gait training for the last 6 months of the study.
|
|---|---|---|
|
Change in Health-related Quality of Life, Domain 3
Pre Gait Training
|
63.46 scores on a scale
Standard Deviation 21.42
|
62.50 scores on a scale
Standard Deviation 28.04
|
|
Change in Health-related Quality of Life, Domain 3
Post Gait Training
|
65.00 scores on a scale
Standard Deviation 16.13
|
57.33 scores on a scale
Standard Deviation 28.93
|
SECONDARY outcome
Timeframe: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)Assessed by psychological domain of the World Health Organization Quality-of-Life Scale (WHOQOL-BREF), Domain 4 reports on the participant's environment, with raw score ranging from 8-40, and transformed scores to a 0-100 point interval. Higher scores (raw=40, transformed=100) correspond to greater perceived quality of life pertaining to participant's environment.
Outcome measures
| Measure |
Immediate Gait Training
n=13 Participants
Participants assigned to this arm will begin Exoskeleton assisted gait training right away and will continue training for the first 6 months of the study.
|
Delayed Gait Training
n=6 Participants
Participants assigned to this arm will not gait train for 6 months. They will engage in Exoskeleton assisted gait training for the last 6 months of the study.
|
|---|---|---|
|
Change in Health-related Quality of Life, Domain 4
Pre Gait Training
|
68.38 scores on a scale
Standard Deviation 13.78
|
63.50 scores on a scale
Standard Deviation 11.50
|
|
Change in Health-related Quality of Life, Domain 4
Post Gait Training
|
71.69 scores on a scale
Standard Deviation 17.62
|
62.66 scores on a scale
Standard Deviation 5.81
|
Adverse Events
Immediate Gait Training
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Delayed Gait Training
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Immediate Gait Training
n=13 participants at risk
Participants assigned to this arm will begin Exoskeleton assisted gait training right away and will continue training for the first 6 months of the study.
|
Delayed Gait Training
n=6 participants at risk
Participants assigned to this arm will not gait train for 6 months. They will engage in Exoskeleton assisted gait training for the last 6 months of the study.
|
|---|---|---|
|
General disorders
Spasticity
|
0.00%
0/13 • Adverse event data was tracked and collected from each participant's time of enrollment through their end of study, an average of 13 months.
|
16.7%
1/6 • Adverse event data was tracked and collected from each participant's time of enrollment through their end of study, an average of 13 months.
|
|
General disorders
Bowel or bladder accident during gaiting
|
46.2%
6/13 • Adverse event data was tracked and collected from each participant's time of enrollment through their end of study, an average of 13 months.
|
66.7%
4/6 • Adverse event data was tracked and collected from each participant's time of enrollment through their end of study, an average of 13 months.
|
|
Skin and subcutaneous tissue disorders
Skin breakdown
|
92.3%
12/13 • Adverse event data was tracked and collected from each participant's time of enrollment through their end of study, an average of 13 months.
|
100.0%
6/6 • Adverse event data was tracked and collected from each participant's time of enrollment through their end of study, an average of 13 months.
|
|
General disorders
Pain
|
30.8%
4/13 • Adverse event data was tracked and collected from each participant's time of enrollment through their end of study, an average of 13 months.
|
0.00%
0/6 • Adverse event data was tracked and collected from each participant's time of enrollment through their end of study, an average of 13 months.
|
|
General disorders
Lower extremity swelling
|
46.2%
6/13 • Adverse event data was tracked and collected from each participant's time of enrollment through their end of study, an average of 13 months.
|
50.0%
3/6 • Adverse event data was tracked and collected from each participant's time of enrollment through their end of study, an average of 13 months.
|
|
General disorders
Heterotopic ossification
|
7.7%
1/13 • Adverse event data was tracked and collected from each participant's time of enrollment through their end of study, an average of 13 months.
|
0.00%
0/6 • Adverse event data was tracked and collected from each participant's time of enrollment through their end of study, an average of 13 months.
|
|
General disorders
Orthostasis
|
7.7%
1/13 • Adverse event data was tracked and collected from each participant's time of enrollment through their end of study, an average of 13 months.
|
0.00%
0/6 • Adverse event data was tracked and collected from each participant's time of enrollment through their end of study, an average of 13 months.
|
|
General disorders
Autonomic Dysreflexia
|
0.00%
0/13 • Adverse event data was tracked and collected from each participant's time of enrollment through their end of study, an average of 13 months.
|
16.7%
1/6 • Adverse event data was tracked and collected from each participant's time of enrollment through their end of study, an average of 13 months.
|
|
General disorders
Compressive neuropathy of the hands
|
7.7%
1/13 • Adverse event data was tracked and collected from each participant's time of enrollment through their end of study, an average of 13 months.
|
0.00%
0/6 • Adverse event data was tracked and collected from each participant's time of enrollment through their end of study, an average of 13 months.
|
|
General disorders
Fall (i.e. due to device failure, outside of gait-training)
|
15.4%
2/13 • Adverse event data was tracked and collected from each participant's time of enrollment through their end of study, an average of 13 months.
|
16.7%
1/6 • Adverse event data was tracked and collected from each participant's time of enrollment through their end of study, an average of 13 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place