Trial Outcomes & Findings for Dopaminergic Enhancement of Rehabilitation Therapy Early After Stroke (NCT NCT05369533)
NCT ID: NCT05369533
Last Updated: 2025-03-24
Results Overview
Measures arm function using a scale that runs from 0 to 57 points, with higher scores indicating greater arm function.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Measured at baseline and 3 months later
Results posted on
2025-03-24
Participant Flow
Participant milestones
| Measure |
Telerehabilitation + Sinemet
Patients will receive 36 telerehabilitation (TR) sessions targeting arm motor function. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6-8 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. A study pill (Sinemet) is taken one hour before starting TR, for the first 18 sessions.
Telerehabilitation: The telerehabilitation system will deliver rehabilitation treatment sessions via a secured internet-connected computer. TR sessions will be a combination of games, exercises, stroke education, assessments, in addition to videoconferencing with therapists to discuss progress, issues, goals, and changes to the treatment plan.
|
Telerehabilitation + Placebo
Patients will receive 36 telerehabilitation (TR) sessions targeting arm motor function. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6-8 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. A study pill (placebo) is taken one hour before starting TR, for the first 18 sessions.
Telerehabilitation: The telerehabilitation system will deliver rehabilitation treatment sessions via a secured internet-connected computer. TR sessions will be a combination of games, exercises, stroke education, assessments, in addition to videoconferencing with therapists to discuss progress, issues, goals, and changes to the treatment plan.
|
Usual Care
Participants in the usual care group will receive no TR or study pill, but will continue with the recommendations made by their care team. All participants will be offered TR at the end of the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
10
|
9
|
|
Overall Study
COMPLETED
|
4
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dopaminergic Enhancement of Rehabilitation Therapy Early After Stroke
Baseline characteristics by cohort
| Measure |
Telerehabilitation + Sinemet
n=6 Participants
Patients will receive 36 telerehabilitation sessions targeting arm motor function. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6-8 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. A study pill (Sinemet) is taken one hour before starting TR, for the first 18 sessions.
Telerehabilitation: The telerehabilitation system will deliver rehabilitation treatment sessions via a secured internet-connected computer. TR sessions will be a combination of games, exercises, stroke education, assessments, in addition to videoconferencing with therapists to discuss progress, issues, goals, and changes to the treatment plan.
|
Telerehabilitation + Placebo
n=10 Participants
Patients will receive 36 telerehabilitation sessions targeting arm motor function. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6-8 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. A study pill (Placebo) is taken one hour before starting TR, for the first 18 sessions.
|
Usual Care
n=9 Participants
Participants in the usual care group will receive no TR or study pill, but will continue with the recommendations made by their care team. All participants will be offered TR at the end of the study.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.8 years
n=5 Participants
|
65.2 years
n=7 Participants
|
66.4 years
n=5 Participants
|
64.4 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Action Research Arm Test
|
20.7 units on a scale
STANDARD_DEVIATION 8.9 • n=5 Participants
|
18 units on a scale
STANDARD_DEVIATION 12.2 • n=7 Participants
|
18.3 units on a scale
STANDARD_DEVIATION 12.7 • n=5 Participants
|
18.8 units on a scale
STANDARD_DEVIATION 11.3 • n=4 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline and 3 months laterMeasures arm function using a scale that runs from 0 to 57 points, with higher scores indicating greater arm function.
Outcome measures
| Measure |
Telerehabilitation + Sinemet
n=6 Participants
Patients will receive 36 telerehabilitation sessions targeting arm motor function. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6-8 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. Patients will take Sinemet one hour before starting TR, for the first 18 sessions.
Telerehabilitation: The telerehabilitation system will deliver rehabilitation treatment sessions via a secured internet-connected computer. TR sessions will be a combination of games, exercises, stroke education, assessments, in addition to videoconferencing with therapists to discuss progress, issues, goals, and changes to the treatment plan.
Sinemet Pill: Sinemet 25/100 will be taken 1 hour prior to TR, for the first 18 sessions.
|
Telerehabilitation + Placebo
n=10 Participants
Patients will receive 36 telerehabilitation sessions targeting arm motor function. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6-8 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. Patients will take a study pill (placebo) one hour before starting TR, for the first 18 sessions.
Telerehabilitation: The telerehabilitation system will deliver rehabilitation treatment sessions via a secured internet-connected computer. TR sessions will be a combination of games, exercises, stroke education, assessments, in addition to videoconferencing with therapists to discuss progress, issues, goals, and changes to the treatment plan.
|
Usual Care
n=9 Participants
Participants in the usual care group will receive no TR or study pill, but will continue with the recommendations made by their care team. All participants will be offered TR at the end of the study.
|
|---|---|---|---|
|
Change in Action Research Arm Test Score From Baseline to 3 Months
|
23.5 score on a scale
Standard Deviation 6.8
|
24 score on a scale
Standard Deviation 13.7
|
15.1 score on a scale
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Measured at baseline and 3 months laterMeasures arm motor impairment using a scale that runs from 0 to 66 points, with higher scores indicating greater arm motor function (less impairment)
Outcome measures
| Measure |
Telerehabilitation + Sinemet
n=6 Participants
Patients will receive 36 telerehabilitation sessions targeting arm motor function. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6-8 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. Patients will take Sinemet one hour before starting TR, for the first 18 sessions.
Telerehabilitation: The telerehabilitation system will deliver rehabilitation treatment sessions via a secured internet-connected computer. TR sessions will be a combination of games, exercises, stroke education, assessments, in addition to videoconferencing with therapists to discuss progress, issues, goals, and changes to the treatment plan.
Sinemet Pill: Sinemet 25/100 will be taken 1 hour prior to TR, for the first 18 sessions.
|
Telerehabilitation + Placebo
n=10 Participants
Patients will receive 36 telerehabilitation sessions targeting arm motor function. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6-8 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. Patients will take a study pill (placebo) one hour before starting TR, for the first 18 sessions.
Telerehabilitation: The telerehabilitation system will deliver rehabilitation treatment sessions via a secured internet-connected computer. TR sessions will be a combination of games, exercises, stroke education, assessments, in addition to videoconferencing with therapists to discuss progress, issues, goals, and changes to the treatment plan.
|
Usual Care
n=9 Participants
Participants in the usual care group will receive no TR or study pill, but will continue with the recommendations made by their care team. All participants will be offered TR at the end of the study.
|
|---|---|---|---|
|
Change in Arm Motor Fugl-Meyer Scale From Baseline to 3 Months
|
23.8 score on a scale
Standard Deviation 5.4
|
21.9 score on a scale
Standard Deviation 12
|
12 score on a scale
Standard Deviation 5.6
|
Adverse Events
Telerehabilitation + Sinemet
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Telerehabilitation + Placebo
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Usual Care
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Telerehabilitation + Sinemet
n=6 participants at risk
Patients will receive 36 telerehabilitation (TR) sessions targeting arm motor function. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6-8 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. A study pill (Sinemet) is taken one hour before starting TR, for the first 18 sessions.
Telerehabilitation: The telerehabilitation system will deliver rehabilitation treatment sessions via a secured internet-connected computer. TR sessions will be a combination of games, exercises, stroke education, assessments, in addition to videoconferencing with therapists to discuss progress, issues, goals, and changes to the treatment plan.
|
Telerehabilitation + Placebo
n=10 participants at risk
Patients will receive 36 telerehabilitation (TR) sessions targeting arm motor function. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6-8 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. A study pill (placebo) is taken one hour before starting TR, for the first 18 sessions.
Telerehabilitation: The telerehabilitation system will deliver rehabilitation treatment sessions via a secured internet-connected computer. TR sessions will be a combination of games, exercises, stroke education, assessments, in addition to videoconferencing with therapists to discuss progress, issues, goals, and changes to the treatment plan.
|
Usual Care
n=9 participants at risk
Participants in the usual care group will receive no TR or study pill, but will continue with the recommendations made by their care team. All participants will be offered TR at the end of the study.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Hospitalization (unrelated to study procedures)
|
16.7%
1/6 • Number of events 1 • 3 months
|
0.00%
0/10 • 3 months
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Hospitalization due to GI-related issues (unrelated to study procedures)
|
0.00%
0/6 • 3 months
|
10.0%
1/10 • Number of events 1 • 3 months
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization due to fluid build-up (unrelated to study procedures)
|
0.00%
0/6 • 3 months
|
20.0%
2/10 • Number of events 2 • 3 months
|
0.00%
0/9 • 3 months
|
|
Cardiac disorders
Hospitalization due to cardiac issues (unrelated to study procedures)
|
0.00%
0/6 • 3 months
|
0.00%
0/10 • 3 months
|
11.1%
1/9 • Number of events 1 • 3 months
|
|
Nervous system disorders
Hospitalization due to neurological issue (unrelated to study procedures)
|
0.00%
0/6 • 3 months
|
0.00%
0/10 • 3 months
|
11.1%
1/9 • Number of events 1 • 3 months
|
Other adverse events
| Measure |
Telerehabilitation + Sinemet
n=6 participants at risk
Patients will receive 36 telerehabilitation (TR) sessions targeting arm motor function. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6-8 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. A study pill (Sinemet) is taken one hour before starting TR, for the first 18 sessions.
Telerehabilitation: The telerehabilitation system will deliver rehabilitation treatment sessions via a secured internet-connected computer. TR sessions will be a combination of games, exercises, stroke education, assessments, in addition to videoconferencing with therapists to discuss progress, issues, goals, and changes to the treatment plan.
|
Telerehabilitation + Placebo
n=10 participants at risk
Patients will receive 36 telerehabilitation (TR) sessions targeting arm motor function. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6-8 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. A study pill (placebo) is taken one hour before starting TR, for the first 18 sessions.
Telerehabilitation: The telerehabilitation system will deliver rehabilitation treatment sessions via a secured internet-connected computer. TR sessions will be a combination of games, exercises, stroke education, assessments, in addition to videoconferencing with therapists to discuss progress, issues, goals, and changes to the treatment plan.
|
Usual Care
n=9 participants at risk
Participants in the usual care group will receive no TR or study pill, but will continue with the recommendations made by their care team. All participants will be offered TR at the end of the study.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Loss of balance (unrelated to study)
|
0.00%
0/6 • 3 months
|
10.0%
1/10 • Number of events 1 • 3 months
|
0.00%
0/9 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Pain (not related to study)
|
33.3%
2/6 • Number of events 2 • 3 months
|
0.00%
0/10 • 3 months
|
0.00%
0/9 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place