Trial Outcomes & Findings for The General Use of Robots in Stroke Recovery: the Anklebot (NCT NCT02249832)
NCT ID: NCT02249832
Last Updated: 2021-03-09
Results Overview
Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (\<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (\>0.8m/sec) functioning. Mean gait speeds on the 10m Walk Test at comfortable pace (m/sec) were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).
COMPLETED
NA
55 participants
baseline, discharge (week 6), 3 month FU (overall week 18)
2021-03-09
Participant Flow
All participants received eighteen sessions of seated anklebot training. Upon analysis, subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to well standardized gait speed performance groups: low (\<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (\>0.8m/sec) functioning.
Participant milestones
| Measure |
Seated Robotic Ankle Therapy
Participants received eighteen 1 hour sessions (3 times/week for 6 weeks) of seated anklebot training with the MIT Anklebot.
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|---|---|
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Overall Study
STARTED
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55
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Overall Study
COMPLETED
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42
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Overall Study
NOT COMPLETED
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13
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Reasons for withdrawal
| Measure |
Seated Robotic Ankle Therapy
Participants received eighteen 1 hour sessions (3 times/week for 6 weeks) of seated anklebot training with the MIT Anklebot.
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|---|---|
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Overall Study
Withdrawal by Subject
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3
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Overall Study
Lost to Follow-up
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10
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Baseline Characteristics
The General Use of Robots in Stroke Recovery: the Anklebot
Baseline characteristics by cohort
| Measure |
Seated Robotic Ankle Therapy
n=55 Participants
Participants received eighteen, 1 hour sessions (3 times/week for 6 weeks) of seated anklebot training with the MIT Anklebot.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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33 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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22 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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37 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Asian
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8 Participants
n=5 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Black or African American
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6 Participants
n=5 Participants
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Race (NIH/OMB)
White
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40 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, discharge (week 6), 3 month FU (overall week 18)Population: Subjects were stratified according to clinically established gait speed impairment levels based on average admission gait speed on the 10 Meter Walk Test at comfortable pace.
Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (\<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (\>0.8m/sec) functioning. Mean gait speeds on the 10m Walk Test at comfortable pace (m/sec) were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).
Outcome measures
| Measure |
Low Gait Speed Group
n=21 Participants
The low gait speed group included all subjects with a mean gait speed of \<0.4m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.
|
Moderate Gait Speed Group
n=14 Participants
The moderate gait speed group included all subjects with a mean gait speed of 0.4-0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.
|
High Gait Speed Group
n=7 Participants
The high gait speed group included all subjects with a mean gait speed of \>0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.
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|---|---|---|---|
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Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace.
Mean gait speed at baseline
|
0.22 m/sec
Standard Error 0.02
|
0.53 m/sec
Standard Error 0.03
|
1.02 m/sec
Standard Error 0.07
|
|
Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace.
Mean gait speed at discharge (week 6)
|
0.26 m/sec
Standard Error 0.02
|
0.62 m/sec
Standard Error 0.04
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1.18 m/sec
Standard Error 0.12
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|
Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace.
Mean gait speed at 3month FU (overall week 18)
|
0.24 m/sec
Standard Error 0.02
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0.66 m/sec
Standard Error 0.04
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1.29 m/sec
Standard Error 0.10
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SECONDARY outcome
Timeframe: baseline, discharge (week 6), 3 month FU (overall week 18)Population: Subjects were stratified according to clinically established gait speed impairment levels based on average admission gait speed on the 10 Meter Walk Test at comfortable pace.
Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (\<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (\>0.8m/sec) functioning. Mean gait speeds on the 10m Walk Test at fast pace (m/sec) were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).
Outcome measures
| Measure |
Low Gait Speed Group
n=21 Participants
The low gait speed group included all subjects with a mean gait speed of \<0.4m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.
|
Moderate Gait Speed Group
n=14 Participants
The moderate gait speed group included all subjects with a mean gait speed of 0.4-0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.
|
High Gait Speed Group
n=7 Participants
The high gait speed group included all subjects with a mean gait speed of \>0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.
|
|---|---|---|---|
|
Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Fast Pace.
mean gait speed at baseline
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0.25 m/sec
Standard Error 0.02
|
0.67 m/sec
Standard Error 0.06
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1.30 m/sec
Standard Error 0.13
|
|
Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Fast Pace.
mean gait speed at discharge (week 6)
|
0.29 m/sec
Standard Error 0.03
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0.79 m/sec
Standard Error 0.06
|
1.41 m/sec
Standard Error 0.18
|
|
Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Fast Pace.
mean gait speed at 3 month FU (overall week 18)
|
0.27 m/sec
Standard Error 0.03
|
0.84 m/sec
Standard Error 0.10
|
1.79 m/sec
Standard Error 0.26
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SECONDARY outcome
Timeframe: baseline, discharge (week 6), 3 month FU (overall week 18)Population: Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance levels.
Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (\<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (\>0.8m/sec) functioning. Mean distance walked (m) on the 6 Minute Walk test at comfortable pace were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).
Outcome measures
| Measure |
Low Gait Speed Group
n=21 Participants
The low gait speed group included all subjects with a mean gait speed of \<0.4m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.
|
Moderate Gait Speed Group
n=14 Participants
The moderate gait speed group included all subjects with a mean gait speed of 0.4-0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.
|
High Gait Speed Group
n=7 Participants
The high gait speed group included all subjects with a mean gait speed of \>0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.
|
|---|---|---|---|
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Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute Walk Test at Comfortable Pace.
mean distance at baseline
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68.46 meters
Standard Error 5.76
|
152.92 meters
Standard Error 9.53
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280.43 meters
Standard Error 19.19
|
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Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute Walk Test at Comfortable Pace.
mean distance at discharge (week 6)
|
79.33 meters
Standard Error 5.38
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180.11 meters
Standard Error 11.64
|
319.79 meters
Standard Error 22.91
|
|
Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute Walk Test at Comfortable Pace.
mean distance at 3 month FU (overall week18)
|
75.07 meters
Standard Error 5.62
|
183.34 meters
Standard Error 14.33
|
314.43 meters
Standard Error 21.46
|
Adverse Events
Seated Robotic Ankle Therapy
Serious adverse events
| Measure |
Seated Robotic Ankle Therapy
n=55 participants at risk
All participants received eighteen 1 hour sessions (3x/week for 6 weeks) of seated anklebot training with the MIT anklebot. Prior to the intervention, subjects were initially stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to well standardized and accepted gait speed performance levels: low (\<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (\>0.8m/sec) functioning, in order to determine if there were impairment-level differences in the recovery pattern following ankle training.
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|---|---|
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Musculoskeletal and connective tissue disorders
worsening baseline ankle pain
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1.8%
1/55 • Number of events 1 • eighteen weeks for each subject (6 weeks of ankle training + 12 week FU period).
Safety population included all participants who enrolled in the study.
|
Other adverse events
| Measure |
Seated Robotic Ankle Therapy
n=55 participants at risk
All participants received eighteen 1 hour sessions (3x/week for 6 weeks) of seated anklebot training with the MIT anklebot. Prior to the intervention, subjects were initially stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to well standardized and accepted gait speed performance levels: low (\<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (\>0.8m/sec) functioning, in order to determine if there were impairment-level differences in the recovery pattern following ankle training.
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|---|---|
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Nervous system disorders
neuropathic pain
|
1.8%
1/55 • Number of events 1 • eighteen weeks for each subject (6 weeks of ankle training + 12 week FU period).
Safety population included all participants who enrolled in the study.
|
|
Psychiatric disorders
depression
|
1.8%
1/55 • Number of events 1 • eighteen weeks for each subject (6 weeks of ankle training + 12 week FU period).
Safety population included all participants who enrolled in the study.
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Additional Information
Bruce T. Volpe, MD
Feinstein Institutes for Medical Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place