Trial Outcomes & Findings for The WISE Trial - Walking Improvement for SCI With Exoskeleton (NCT NCT02943915)
NCT ID: NCT02943915
Last Updated: 2023-10-31
Results Overview
The mean change in gait speed demonstrated during the 10MWT after 12 weeks of training and compared between groups. Positive values indicate improvement in gait speed (faster) from baseline to 12 weeks. Negative values indicate a reduction in gait speed (slower) from baseline to 12 weeks.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Baseline and 12 Weeks
Results posted on
2023-10-31
Participant Flow
Run-in category arm contains participants that began the intervention protocol to ensure that assessment and training procedures were practiced and followed as required in the clinical trial protocol. Following the satisfactory completion of at least one set of midpoint assessments during the run-in phase, subsequent main study participants (a separate cohort) were enrolled and randomly assigned. Run-in participant data was not collected or included in these results.
Participant milestones
| Measure |
Group 1: Ekso GT Rehabilitation Therapy
Participants in this group receive Ekso GT (gait training) PT therapy intervention 3 times per week for 12 weeks (36 sessions). Intervention: Ekso GT Rehabilitation therapy
Ekso GT Rehabilitation Therapy: Walking Improvement for Spinal Cord Injuries with Exoskeleton
|
Group 2: Active Controls - BWSTT Therapy
Participants in this group receive a matched number of sessions of standard gait training using body-weight supported treadmill training and overground training. Intervention: Body Weight Supported Treadmill Training
Body Weight Supported (BWS) Treadmill Training: Standard gait training using BWS PT and overground training
|
Group 3: Passive Controls
Participants in this group continue with normal daily activities over 12 weeks.
|
Run-in
Panients in this group began the intervention protocol for the EksoGT group to ensure that assessment and training procedures were practiced and followed as required in the clinical trial protocol.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
6
|
12
|
|
Overall Study
COMPLETED
|
9
|
10
|
6
|
12
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group 1: Ekso GT Rehabilitation Therapy
Participants in this group receive Ekso GT (gait training) PT therapy intervention 3 times per week for 12 weeks (36 sessions). Intervention: Ekso GT Rehabilitation therapy
Ekso GT Rehabilitation Therapy: Walking Improvement for Spinal Cord Injuries with Exoskeleton
|
Group 2: Active Controls - BWSTT Therapy
Participants in this group receive a matched number of sessions of standard gait training using body-weight supported treadmill training and overground training. Intervention: Body Weight Supported Treadmill Training
Body Weight Supported (BWS) Treadmill Training: Standard gait training using BWS PT and overground training
|
Group 3: Passive Controls
Participants in this group continue with normal daily activities over 12 weeks.
|
Run-in
Panients in this group began the intervention protocol for the EksoGT group to ensure that assessment and training procedures were practiced and followed as required in the clinical trial protocol.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
0
|
0
|
|
Overall Study
excluded
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1: Ekso GT Rehabilitation Therapy
n=12 Participants
Participants in this group receive Ekso GT (gait training) PT therapy intervention 3 times per week for 12 weeks (36 sessions). Intervention: Ekso GT Rehabilitation therapy
Ekso GT Rehabilitation Therapy: Walking Improvement for Spinal Cord Injuries with Exoskeleton
|
Group 2: Active Controls - BWSTT Therapy
n=12 Participants
Participants in this group receive a matched number of sessions of standard gait training using body-weight supported treadmill training and overground training. Intervention: Body Weight Supported Treadmill Training
Body Weight Supported (BWS) Treadmill Training: Standard gait training using BWS PT and overground training
|
Group 3: Passive Controls
n=6 Participants
Participants in this group continue with normal daily activities over 12 weeks.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=12 Participants
|
10 Participants
n=12 Participants
|
5 Participants
n=6 Participants
|
27 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=30 Participants
|
|
Age, Continuous
|
41.67 years
n=12 Participants
|
51.91 years
n=12 Participants
|
49 years
n=6 Participants
|
47.2 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=12 Participants
|
6 Participants
n=12 Participants
|
1 Participants
n=6 Participants
|
12 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=12 Participants
|
6 Participants
n=12 Participants
|
5 Participants
n=6 Participants
|
18 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
6 Participants
n=6 Participants
|
30 Participants
n=30 Participants
|
|
Time since injury
|
8.40 years
STANDARD_DEVIATION 8.59 • n=12 Participants
|
7.04 years
STANDARD_DEVIATION 4.37 • n=12 Participants
|
4.37 years
STANDARD_DEVIATION 4.77 • n=6 Participants
|
7.05 years
STANDARD_DEVIATION 6.49 • n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Population does not include participants who withdrew, who did not have completed outcome data, who were excluded, or who were included in the Ekso protocol run-in. Run in participants did not have data collected on them and were only utilized to to ensure that assessment and training procedures were practiced and followed as required in the clinical trial protocol.
The mean change in gait speed demonstrated during the 10MWT after 12 weeks of training and compared between groups. Positive values indicate improvement in gait speed (faster) from baseline to 12 weeks. Negative values indicate a reduction in gait speed (slower) from baseline to 12 weeks.
Outcome measures
| Measure |
Group 2: Active Controls - BWSTT Therapy
n=10 Participants
Participants in this group receive a matched number of sessions of standard gait training using body-weight supported treadmill training and overground training. Intervention: Body Weight Supported Treadmill Training
Body Weight Supported (BWS) Treadmill Training: Standard gait training using BWS PT and overground training
|
Group 3: Passive Controls
n=6 Participants
Participants in this group continue with normal daily activities over 12 weeks.
|
Group 1: Ekso GT Rehabilitation Therapy
n=9 Participants
Participants in this group receive Ekso GT (gait training) PT therapy intervention 3 times per week for 12 weeks (36 sessions). Intervention: Ekso GT Rehabilitation therapy
Ekso GT Rehabilitation Therapy: Walking Improvement for Spinal Cord Injuries with Exoskeleton
|
|---|---|---|---|
|
Change in Gait Speed From Baseline to 12 Weeks Using 10 Meter Walk Test (10MWT)
|
0.07 meters/second
Standard Deviation 0.11
|
0.03 meters/second
Standard Deviation 0.03
|
0.18 meters/second
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Between baseline and 24 weeksPopulation: Population does not include participants who withdrew, who did not have completed outcome data, who were excluded, or who were included in the Ekso protocol run-in. Run in participants did not have data collected on them and were only utilized to to ensure that assessment and training procedures were practiced and followed as required in the clinical trial protocol.
Number of participants who achieve the Minimal Clinically Important Difference (MCID) of 0.15 m/s during the 10MWT when comparing between baseline gait speed and gait speed at 24 weeks.
Outcome measures
| Measure |
Group 2: Active Controls - BWSTT Therapy
n=10 Participants
Participants in this group receive a matched number of sessions of standard gait training using body-weight supported treadmill training and overground training. Intervention: Body Weight Supported Treadmill Training
Body Weight Supported (BWS) Treadmill Training: Standard gait training using BWS PT and overground training
|
Group 3: Passive Controls
n=6 Participants
Participants in this group continue with normal daily activities over 12 weeks.
|
Group 1: Ekso GT Rehabilitation Therapy
n=9 Participants
Participants in this group receive Ekso GT (gait training) PT therapy intervention 3 times per week for 12 weeks (36 sessions). Intervention: Ekso GT Rehabilitation therapy
Ekso GT Rehabilitation Therapy: Walking Improvement for Spinal Cord Injuries with Exoskeleton
|
|---|---|---|---|
|
Number of Participants Who Met the Minimal Clinically Important Difference of 0.15m/s in Gait Speed Per 10 Meter Walk Test (10MWT) From Baseline to 24 Weeks
|
2 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline-24 weeksPopulation: Population does not include participants who withdrew, who did not have completed outcome data, who were excluded, or who were included in the Ekso protocol run-in. Run in participants did not have data collected on them and were only utilized to to ensure that assessment and training procedures were practiced and followed as required in the clinical trial protocol.
6 minute walk test (6MWT) completed at baseline and 24 weeks. Change assessed. Positive values indicate an increase in distance was able to be walked at 24 weeks versus at baseline. Negative values indicate a decrease in distance was walked at 24 weeks versus at baseline.
Outcome measures
| Measure |
Group 2: Active Controls - BWSTT Therapy
n=10 Participants
Participants in this group receive a matched number of sessions of standard gait training using body-weight supported treadmill training and overground training. Intervention: Body Weight Supported Treadmill Training
Body Weight Supported (BWS) Treadmill Training: Standard gait training using BWS PT and overground training
|
Group 3: Passive Controls
n=6 Participants
Participants in this group continue with normal daily activities over 12 weeks.
|
Group 1: Ekso GT Rehabilitation Therapy
n=9 Participants
Participants in this group receive Ekso GT (gait training) PT therapy intervention 3 times per week for 12 weeks (36 sessions). Intervention: Ekso GT Rehabilitation therapy
Ekso GT Rehabilitation Therapy: Walking Improvement for Spinal Cord Injuries with Exoskeleton
|
|---|---|---|---|
|
Change in Distance Covered Over 6 Minutes From Baseline to 24 Weeks
|
346.6 feet
Interval 219.5 to 711.5
|
320 feet
Interval 148.8 to 466.6
|
538 feet
Interval 268.0 to 687.3
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: Population does not include participants who withdrew, who did not have completed outcome data, who were excluded, or who were included in the Ekso protocol run-in. Run in participants did not have data collected on them and were only utilized to to ensure that assessment and training procedures were practiced and followed as required in the clinical trial protocol.
Examined balance and walking in participants at baseline and follow up at 24 weeks. Positive values indicate an improvement of time (less time) required to complete task at 24 week follow up versus at baseline. Negative values indicate a decline, more time required to complete task at follow up versus baseline.
Outcome measures
| Measure |
Group 2: Active Controls - BWSTT Therapy
n=10 Participants
Participants in this group receive a matched number of sessions of standard gait training using body-weight supported treadmill training and overground training. Intervention: Body Weight Supported Treadmill Training
Body Weight Supported (BWS) Treadmill Training: Standard gait training using BWS PT and overground training
|
Group 3: Passive Controls
n=6 Participants
Participants in this group continue with normal daily activities over 12 weeks.
|
Group 1: Ekso GT Rehabilitation Therapy
n=9 Participants
Participants in this group receive Ekso GT (gait training) PT therapy intervention 3 times per week for 12 weeks (36 sessions). Intervention: Ekso GT Rehabilitation therapy
Ekso GT Rehabilitation Therapy: Walking Improvement for Spinal Cord Injuries with Exoskeleton
|
|---|---|---|---|
|
Change in Time Required to Complete Timed Up and Go (TUG) Test From Baseline to 24 Week Follow up
|
30 seconds
Interval 26.0 to 70.7
|
46 seconds
Interval 29.0 to 64.9
|
26.4 seconds
Interval 17.3 to 53.0
|
SECONDARY outcome
Timeframe: Throughout 24 weeksPopulation: Population does not include participants who withdrew, who did not have completed outcome data, who were excluded, or who were included in the Ekso protocol run-in. Run in participants did not have data collected on them and were only utilized to to ensure that assessment and training procedures were practiced and followed as required in the clinical trial protocol.
At each training session, assessed if participant had experienced any falls. Count is number of participants who reported that yes, they did experience a fall.
Outcome measures
| Measure |
Group 2: Active Controls - BWSTT Therapy
n=10 Participants
Participants in this group receive a matched number of sessions of standard gait training using body-weight supported treadmill training and overground training. Intervention: Body Weight Supported Treadmill Training
Body Weight Supported (BWS) Treadmill Training: Standard gait training using BWS PT and overground training
|
Group 3: Passive Controls
n=6 Participants
Participants in this group continue with normal daily activities over 12 weeks.
|
Group 1: Ekso GT Rehabilitation Therapy
n=9 Participants
Participants in this group receive Ekso GT (gait training) PT therapy intervention 3 times per week for 12 weeks (36 sessions). Intervention: Ekso GT Rehabilitation therapy
Ekso GT Rehabilitation Therapy: Walking Improvement for Spinal Cord Injuries with Exoskeleton
|
|---|---|---|---|
|
Number of Participants Who Experienced a Fall During Protocol
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline-24 weeksPopulation: Population does not include participants who withdrew, who did not have completed outcome data, who were excluded, or who were included in the Ekso protocol run-in. Run in participants did not have data collected on them and were only utilized to to ensure that assessment and training procedures were practiced and followed as required in the clinical trial protocol.
Measurement of static and dynamic sitting and standing balance completed at baseline and at 24 weeks. Berg balance scale is a 14 item test with each item scored from 0-4. Possible scores range from 0-56. Higher scores indicate a lower risk of falls and better balance. Positive numbers indicate an improvement in Berg balance scale (scored out of 56), meaning that the participant scored higher at 24 weeks than at baseline. Negative values indicate a decline in performance of the Berg balance scale (scored out of 56), meaning that the participant scored lower at 24 weeks than at baseline.
Outcome measures
| Measure |
Group 2: Active Controls - BWSTT Therapy
n=11 Participants
Participants in this group receive a matched number of sessions of standard gait training using body-weight supported treadmill training and overground training. Intervention: Body Weight Supported Treadmill Training
Body Weight Supported (BWS) Treadmill Training: Standard gait training using BWS PT and overground training
|
Group 3: Passive Controls
n=6 Participants
Participants in this group continue with normal daily activities over 12 weeks.
|
Group 1: Ekso GT Rehabilitation Therapy
n=12 Participants
Participants in this group receive Ekso GT (gait training) PT therapy intervention 3 times per week for 12 weeks (36 sessions). Intervention: Ekso GT Rehabilitation therapy
Ekso GT Rehabilitation Therapy: Walking Improvement for Spinal Cord Injuries with Exoskeleton
|
|---|---|---|---|
|
Change in Berg Balance Scale Score From Baseline to 24 Weeks
|
19.22 score on a scale
Standard Deviation 8.4
|
17.3 score on a scale
Standard Deviation 6.5
|
18.7 score on a scale
Standard Deviation 10.4
|
Adverse Events
Group 1: Ekso GT Rehabilitation Therapy
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Group 2: Active Controls - BWSTT Therapy
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 3: Passive Controls
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Ekso Run in Participants
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Ekso GT Rehabilitation Therapy
n=14 participants at risk
Participants in this group receive Ekso GT (gait training) PT therapy intervention 3 times per week for 12 weeks (36 sessions). Intervention: Ekso GT Rehabilitation therapy
Ekso GT Rehabilitation Therapy: Walking Improvement for Spinal Cord Injuries with Exoskeleton
|
Group 2: Active Controls - BWSTT Therapy
n=13 participants at risk
Participants in this group receive a matched number of sessions of standard gait training using body-weight supported treadmill training and overground training. Intervention: Body Weight Supported Treadmill Training
Body Weight Supported (BWS) Treadmill Training: Standard gait training using BWS PT and overground training
|
Group 3: Passive Controls
n=6 participants at risk
Participants in this group continue with normal daily activities over 12 weeks.
|
Ekso Run in Participants
n=12 participants at risk
Participants in this group receive Ekso GT (gait training) PT therapy intervention but were not included in full data collection. This was completed to help the therapists get used to the protocol and use of the device.
|
|---|---|---|---|---|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/14 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
7.7%
1/13 • Number of events 1 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
0.00%
0/6 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
0.00%
0/12 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
|
Musculoskeletal and connective tissue disorders
lower extremity numbness
|
0.00%
0/14 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
7.7%
1/13 • Number of events 1 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
0.00%
0/6 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
0.00%
0/12 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
|
Immune system disorders
allergic reaction to medication
|
7.1%
1/14 • Number of events 1 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
0.00%
0/13 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
0.00%
0/6 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
0.00%
0/12 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
Other adverse events
| Measure |
Group 1: Ekso GT Rehabilitation Therapy
n=14 participants at risk
Participants in this group receive Ekso GT (gait training) PT therapy intervention 3 times per week for 12 weeks (36 sessions). Intervention: Ekso GT Rehabilitation therapy
Ekso GT Rehabilitation Therapy: Walking Improvement for Spinal Cord Injuries with Exoskeleton
|
Group 2: Active Controls - BWSTT Therapy
n=13 participants at risk
Participants in this group receive a matched number of sessions of standard gait training using body-weight supported treadmill training and overground training. Intervention: Body Weight Supported Treadmill Training
Body Weight Supported (BWS) Treadmill Training: Standard gait training using BWS PT and overground training
|
Group 3: Passive Controls
n=6 participants at risk
Participants in this group continue with normal daily activities over 12 weeks.
|
Ekso Run in Participants
n=12 participants at risk
Participants in this group receive Ekso GT (gait training) PT therapy intervention but were not included in full data collection. This was completed to help the therapists get used to the protocol and use of the device.
|
|---|---|---|---|---|
|
Cardiac disorders
Blood pressure issues
|
7.1%
1/14 • Number of events 1 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
7.7%
1/13 • Number of events 1 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
0.00%
0/6 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
0.00%
0/12 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
|
Musculoskeletal and connective tissue disorders
Fall
|
28.6%
4/14 • Number of events 12 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
38.5%
5/13 • Number of events 14 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
16.7%
1/6 • Number of events 4 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
33.3%
4/12 • Number of events 9 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
|
Infections and infestations
Illness
|
35.7%
5/14 • Number of events 6 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
15.4%
2/13 • Number of events 4 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
0.00%
0/6 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
25.0%
3/12 • Number of events 3 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
|
Nervous system disorders
Nerve pain or numbness
|
14.3%
2/14 • Number of events 4 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
7.7%
1/13 • Number of events 1 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
0.00%
0/6 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
8.3%
1/12 • Number of events 1 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
|
Musculoskeletal and connective tissue disorders
Pain
|
21.4%
3/14 • Number of events 5 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
46.2%
6/13 • Number of events 8 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
0.00%
0/6 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
33.3%
4/12 • Number of events 9 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
|
Surgical and medical procedures
Planned medical or surgical procedure
|
0.00%
0/14 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
23.1%
3/13 • Number of events 3 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
0.00%
0/6 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
8.3%
1/12 • Number of events 1 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
|
Skin and subcutaneous tissue disorders
Skin bruising, redness, or rash
|
42.9%
6/14 • Number of events 9 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
23.1%
3/13 • Number of events 4 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
0.00%
0/6 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
25.0%
3/12 • Number of events 5 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
|
Skin and subcutaneous tissue disorders
Swelling
|
7.1%
1/14 • Number of events 1 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
7.7%
1/13 • Number of events 1 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
0.00%
0/6 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
8.3%
1/12 • Number of events 1 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
|
Infections and infestations
Urinary Tract Infection
|
21.4%
3/14 • Number of events 4 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
30.8%
4/13 • Number of events 7 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
33.3%
2/6 • Number of events 2 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
0.00%
0/12 • AEs tracked through each participant's intervention period over 12 consecutive weeks.
Participants using devices, no risk for death
|
Additional Information
Dylan Edwards
Moss Rehabilitation Research Institute, Elkins Park, PA, USA
Phone: 215-663-6554
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place