Stroke
Conditions
Keywords
stroke, CVA, cerebrovascular accident, cerebral stroke, robotic therapy, anklebot, physical therapy
Brief summary
The purpose of this study is to determine if isolated robot-assisted training of the ankle joint improves chronic hemiparetic gait in patients after stroke.
Interventions
DEVICEseated robot-assisted ankle therapy
The MIT anklebot provides over one thousand total dorsi/plantar flexion and inversion/eversion robot-assisted movements of the ankle while in a seated position.
Sponsors
Northwell Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All subjects received 18 sessions (3 times per week for 6 weeks) of seated robotic ankle training. Upon analysis, subjects were stratified by 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) gait functioning.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior * Cognitive function sufficient enough to understand experiments and follow instructions * Some amount of independent ambulation (with orthoses or walker)
Exclusion criteria
* Botox treatment within 6-weeks of enrollment; * Fixed contraction deformity in the affected limb; * Complete and total flaccid paralysis of all lower extremity motor function; * Unable to ambulate except with the aid of another person
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace. | baseline, discharge (week 6), 3 month FU (overall week 18) | 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)). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Fast Pace. | baseline, discharge (week 6), 3 month FU (overall week 18) | 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)). |
| Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute Walk Test at Comfortable Pace. | baseline, discharge (week 6), 3 month FU (overall week 18) | 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)). |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Seated Robotic Ankle Therapy Participants received eighteen, 1 hour sessions (3 times/week for 6 weeks) of seated anklebot training with the MIT Anklebot. | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Seated Robotic Ankle Therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 22 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Region of Enrollment United States | 55 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 55 |
| other Total, other adverse events | 2 / 55 |
| serious Total, serious adverse events | 1 / 55 |
Outcome results
Primary
Mean Change From Baseline in Gait Speed (m/Sec) 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)).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Gait Speed Group | 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 |
| Low Gait Speed Group | 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 |
| Low Gait Speed Group | 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 |
| Moderate Gait Speed Group | 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) | 0.62 m/sec | Standard Error 0.04 |
| Moderate Gait Speed Group | Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace. | Mean gait speed at baseline | 0.53 m/sec | Standard Error 0.03 |
| Moderate Gait Speed Group | 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) | 0.66 m/sec | Standard Error 0.04 |
| High Gait Speed Group | Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace. | Mean gait speed at baseline | 1.02 m/sec | Standard Error 0.07 |
| High Gait Speed Group | 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) | 1.29 m/sec | Standard Error 0.1 |
| High Gait Speed Group | 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) | 1.18 m/sec | Standard Error 0.12 |
p-value: <0.001ANOVA
Secondary
Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute 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 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)).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Gait Speed Group | 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 |
| Low Gait Speed Group | Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute Walk Test at Comfortable Pace. | mean distance at baseline | 68.46 meters | Standard Error 5.76 |
| Low Gait Speed Group | 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 |
| Moderate Gait Speed Group | 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) | 183.34 meters | Standard Error 14.33 |
| Moderate Gait Speed Group | Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute Walk Test at Comfortable Pace. | mean distance at baseline | 152.92 meters | Standard Error 9.53 |
| Moderate Gait Speed Group | Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute Walk Test at Comfortable Pace. | mean distance at discharge (week 6) | 180.11 meters | Standard Error 11.64 |
| High Gait Speed Group | 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) | 314.43 meters | Standard Error 21.46 |
| High Gait Speed Group | Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute Walk Test at Comfortable Pace. | mean distance at baseline | 280.43 meters | Standard Error 19.19 |
| High Gait Speed Group | Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute Walk Test at Comfortable Pace. | mean distance at discharge (week 6) | 319.79 meters | Standard Error 22.91 |
p-value: 0.001ANOVA
Secondary
Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Fast 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)).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Gait Speed Group | 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 |
| Low Gait Speed Group | 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 |
| Low Gait Speed Group | Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Fast Pace. | mean gait speed at baseline | 0.25 m/sec | Standard Error 0.02 |
| Moderate Gait Speed Group | 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) | 0.79 m/sec | Standard Error 0.06 |
| Moderate Gait Speed Group | Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Fast Pace. | mean gait speed at baseline | 0.67 m/sec | Standard Error 0.06 |
| Moderate Gait Speed Group | 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) | 0.84 m/sec | Standard Error 0.1 |
| High Gait Speed Group | Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Fast Pace. | mean gait speed at baseline | 1.30 m/sec | Standard Error 0.13 |
| High Gait Speed Group | 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) | 1.79 m/sec | Standard Error 0.26 |
| High Gait Speed Group | 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) | 1.41 m/sec | Standard Error 0.18 |
Comparison: A 3x3 repeated measures ANOVA was performed with group (mean gait speed in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).p-value: <0.001ANOVA