Trial Outcomes & Findings for Pilot Study of Powered Exoskeleton Use for Gait Rehabilitation in Individuals With Multiple Sclerosis (NCT NCT04000373)
NCT ID: NCT04000373
Last Updated: 2022-06-27
Results Overview
Percentage of enrolled participants who drop out of the study before the end of the treatment period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
0-14 weeks
Results posted on
2022-06-27
Participant Flow
Patients were recruited and enrolled between July 2019 and October 2019 in the outpatient clinic.
Participant milestones
| Measure |
Gait Training With Exoskeleton Device
uncontrolled pre-post intervention study of gait training using the Ekso GT™exoskeleton
Ekso GT™ exoskeleton: The rehabilitation treatment will consist of 3 sessions per week for 8 weeks, for a total of 24 sessions. Missed sessions will be made up if possible. Each session will be scheduled for 60 minutes, and will consist of stretching, overground gait training, and gait training with the study device. Rest periods will be provided as necessary during the training visits.
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|---|---|
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Overall Study
STARTED
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5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of Powered Exoskeleton Use for Gait Rehabilitation in Individuals With Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Gait Training With Exoskeleton Device
n=5 Participants
uncontrolled pre-post intervention study of gait training using the Ekso GT™exoskeleton
Ekso GT™ exoskeleton: The rehabilitation treatment will consist of 3 sessions per week for 8 weeks, for a total of 24 sessions. Missed sessions will be made up if possible. Each session will be scheduled for 60 minutes, and will consist of stretching, overground gait training, and gait training with the study device. Rest periods will be provided as necessary during the training visits.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
|
The Expanded Disability Status Scale = 5.5 to 7.5.Range from 0 to 10, higher scores worse outcome
|
6.30 units on a scale
STANDARD_DEVIATION 0.27 • n=5 Participants
|
PRIMARY outcome
Timeframe: 0-14 weeksPercentage of enrolled participants who drop out of the study before the end of the treatment period.
Outcome measures
| Measure |
Gait Training With Exoskeleton Device
n=5 Participants
uncontrolled pre-post intervention study of gait training using the Ekso GT™exoskeleton
Ekso GT™ exoskeleton: The rehabilitation treatment will consist of 3 sessions per week for 8 weeks, for a total of 24 sessions. Missed sessions will be made up if possible. Each session will be scheduled for 60 minutes, and will consist of stretching, overground gait training, and gait training with the study device. Rest periods will be provided as necessary during the training visits.
|
|---|---|
|
Dropout Rate
|
0 Participants
|
PRIMARY outcome
Timeframe: 0-14 weeks.All adverse events were collected throughout the study for each participant, up to 14 weeks",
Outcome measures
| Measure |
Gait Training With Exoskeleton Device
n=5 Participants
uncontrolled pre-post intervention study of gait training using the Ekso GT™exoskeleton
Ekso GT™ exoskeleton: The rehabilitation treatment will consist of 3 sessions per week for 8 weeks, for a total of 24 sessions. Missed sessions will be made up if possible. Each session will be scheduled for 60 minutes, and will consist of stretching, overground gait training, and gait training with the study device. Rest periods will be provided as necessary during the training visits.
|
|---|---|
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Adverse Events
|
4 Participants
|
SECONDARY outcome
Timeframe: 0-14 weeksChange in walking speed on the Timed 25 Foot Walk between baseline, end of treatment, and end of follow-up period.
Outcome measures
| Measure |
Gait Training With Exoskeleton Device
n=5 Participants
uncontrolled pre-post intervention study of gait training using the Ekso GT™exoskeleton
Ekso GT™ exoskeleton: The rehabilitation treatment will consist of 3 sessions per week for 8 weeks, for a total of 24 sessions. Missed sessions will be made up if possible. Each session will be scheduled for 60 minutes, and will consist of stretching, overground gait training, and gait training with the study device. Rest periods will be provided as necessary during the training visits.
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|---|---|
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Timed 25 Foot Walk
Baseline to end of treatment
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0.72 seconds
Standard Deviation 1.20
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Timed 25 Foot Walk
Baseline to end of follow-up
|
1.24 seconds
Standard Deviation 2.87
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Adverse Events
Gait Training With Exoskeleton Device
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gait Training With Exoskeleton Device
n=5 participants at risk
uncontrolled pre-post intervention study of gait training using the Ekso GT™exoskeleton
Ekso GT™ exoskeleton: The rehabilitation treatment will consist of 3 sessions per week for 8 weeks, for a total of 24 sessions. Missed sessions will be made up if possible. Each session will be scheduled for 60 minutes, and will consist of stretching, overground gait training, and gait training with the study device. Rest periods will be provided as necessary during the training visits.
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|---|---|
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Nervous system disorders
Fall
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40.0%
2/5 • Number of events 2 • all adverse events were collected throughout the study for each participant, up to 14 weeks.
All probable and possibly related to device use events were collected along with other adverse events including falls
|
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Musculoskeletal and connective tissue disorders
Low back pain
|
20.0%
1/5 • Number of events 2 • all adverse events were collected throughout the study for each participant, up to 14 weeks.
All probable and possibly related to device use events were collected along with other adverse events including falls
|
|
Musculoskeletal and connective tissue disorders
Chest wall soreness
|
20.0%
1/5 • Number of events 1 • all adverse events were collected throughout the study for each participant, up to 14 weeks.
All probable and possibly related to device use events were collected along with other adverse events including falls
|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
20.0%
1/5 • Number of events 1 • all adverse events were collected throughout the study for each participant, up to 14 weeks.
All probable and possibly related to device use events were collected along with other adverse events including falls
|
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Nervous system disorders
Back muscle weakness
|
20.0%
1/5 • Number of events 1 • all adverse events were collected throughout the study for each participant, up to 14 weeks.
All probable and possibly related to device use events were collected along with other adverse events including falls
|
|
Skin and subcutaneous tissue disorders
Bruising
|
20.0%
1/5 • Number of events 1 • all adverse events were collected throughout the study for each participant, up to 14 weeks.
All probable and possibly related to device use events were collected along with other adverse events including falls
|
Additional Information
Research Nurse Coordinator
Cleveland Clinic Neurological Institute Mellen Center
Phone: 216-445-5877
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place