Trial Outcomes & Findings for Bilateral Priming for Upper Extremity Hemiparesis in Older Adults (NCT NCT02277028)
NCT ID: NCT02277028
Last Updated: 2023-10-27
Results Overview
The change score (Follow-up - Baseline) for the Chedoke Arm and Hand Activity Index 9 is reported. The change score scale ranges 0(min) to 63 (max). Higher scores indicate greater ability. Follow-up is at 6 weeks post treatment cessation. The scale measure bilateral activity performance.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
value at 6 weeks minus value at baseline
Results posted on
2023-10-27
Participant Flow
Participant milestones
| Measure |
Health Education
The group with no priming will receive stroke related health education via a website from the American Heart Association (15 minutes). They will use their affected hand (as they are able) This will be followed by 45 minutes of the same task specific arm training protocol described in the bilateral priming group. This group will follow the same schedule as above. The health education (15 minutes) will be following by task specific training (45 minutes). Subjects will then have a break (betw. 30-60 minutes) and then repeat the above. Total time on health education website for one day is 30 minutes. Total task specific training for one day is 90 minutes
priming and task specific training: This task specific training protocol has been used in several clinical trials.
8
|
Bilateral Priming
Bilateral priming a priming technique which is non-invasive and free of side effects. The technique described in this study uses bilateral, symmetrical, rhythmic movement "bilateral priming" and its purpose is to ready the motor cortex for functional limb training. A "rocker" is used so that the less affected limb can drive the affected one in symmetrical wrist flexion and extension. The priming (15 minutes) will be following by task specific training (45 minutes). Subjects will then have a break (betw. 30-60 minutes) and then repeat the above. Total priming for one day is 30 minutes. Total task specific training for one day is 90 minutes
priming and task specific training: This task specific training protocol has been used in several clinical trials.
8
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Health Education
The group with no priming will receive stroke related health education via a website from the American Heart Association (15 minutes). They will use their affected hand (as they are able) This will be followed by 45 minutes of the same task specific arm training protocol described in the bilateral priming group. This group will follow the same schedule as above. The health education (15 minutes) will be following by task specific training (45 minutes). Subjects will then have a break (betw. 30-60 minutes) and then repeat the above. Total time on health education website for one day is 30 minutes. Total task specific training for one day is 90 minutes
priming and task specific training: This task specific training protocol has been used in several clinical trials.
8
|
Bilateral Priming
Bilateral priming a priming technique which is non-invasive and free of side effects. The technique described in this study uses bilateral, symmetrical, rhythmic movement "bilateral priming" and its purpose is to ready the motor cortex for functional limb training. A "rocker" is used so that the less affected limb can drive the affected one in symmetrical wrist flexion and extension. The priming (15 minutes) will be following by task specific training (45 minutes). Subjects will then have a break (betw. 30-60 minutes) and then repeat the above. Total priming for one day is 30 minutes. Total task specific training for one day is 90 minutes
priming and task specific training: This task specific training protocol has been used in several clinical trials.
8
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Bilateral Priming for Upper Extremity Hemiparesis in Older Adults
Baseline characteristics by cohort
| Measure |
Bilateral Priming
n=8 Participants
Bilateral priming a priming technique which is non-invasive and free of side effects. The technique described in this study uses bilateral, symmetrical, rhythmic movement "bilateral priming" and its purpose is to ready the motor cortex for functional limb training. A "rocker" is used so that the less affected limb can drive the affected one in symmetrical wrist flexion and extension. The priming (15 minutes) will be following by task specific training (45 minutes). Subjects will then have a break (betw. 30-60 minutes) and then repeat the above. Total priming for one day is 30 minutes. Total task specific training for one day is 90 minutes
priming and task specific training: This task specific training protocol has been used in several clinical trials.
|
Health Education
n=8 Participants
The group with no priming will receive stroke related health education via a website from the American Heart Association (15 minutes). They will use their affected hand (as they are able) This will be followed by 45 minutes of the same task specific arm training protocol described in the bilateral priming group. This group will follow the same schedule as above. The health education (15 minutes) will be following by task specific training (45 minutes). Subjects will then have a break (betw. 30-60 minutes) and then repeat the above. Total time on health education website for one day is 30 minutes. Total task specific training for one day is 90 minutes
priming and task specific training: This task specific training protocol has been used in several clinical trials.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: value at 6 weeks minus value at baselinePopulation: individuals who have survived a stroke greater than 6 months prior to enrollment
The change score (Follow-up - Baseline) for the Chedoke Arm and Hand Activity Index 9 is reported. The change score scale ranges 0(min) to 63 (max). Higher scores indicate greater ability. Follow-up is at 6 weeks post treatment cessation. The scale measure bilateral activity performance.
Outcome measures
| Measure |
Bilateral Priming
n=7 Participants
Bilateral priming a priming technique which is non-invasive and free of side effects. The technique described in this study uses bilateral, symmetrical, rhythmic movement "bilateral priming" and its purpose is to ready the motor cortex for functional limb training. A "rocker" is used so that the less affected limb can drive the affected one in symmetrical wrist flexion and extension. The priming (15 minutes) will be following by task specific training (45 minutes). Subjects will then have a break (betw. 30-60 minutes) and then repeat the above. Total priming for one day is 30 minutes. Total task specific training for one day is 90 minutes
priming and task specific training: This task specific training protocol has been used in several clinical trials.
8
|
Health Education
n=7 Participants
The group with no priming will receive stroke related health education via a website from the American Heart Association (15 minutes). They will use their affected hand (as they are able) This will be followed by 45 minutes of the same task specific arm training protocol described in the bilateral priming group. This group will follow the same schedule as above. The health education (15 minutes) will be following by task specific training (45 minutes). Subjects will then have a break (betw. 30-60 minutes) and then repeat the above. Total time on health education website for one day is 30 minutes. Total task specific training for one day is 90 minutes
priming and task specific training: This task specific training protocol has been used in several clinical trials.
8
|
|---|---|---|
|
Change Score of Chedoke Arm and Hand Activity Index Nine (CAHAI 9) Baseline to Follow-up (2 Timepoints)
|
6.69 score on a scale
Standard Deviation 1.2
|
5.03 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: value at 6 weeks minus value at baselinePopulation: individuals who have survived a stroke greater than 6 months prior to enrollment
Change score between 2-time points (6 weeks follow up - baseline) Change score scale: minimum is 0 and maximum is 66. Higher scores indicate better outcomes.
Outcome measures
| Measure |
Bilateral Priming
n=7 Participants
Bilateral priming a priming technique which is non-invasive and free of side effects. The technique described in this study uses bilateral, symmetrical, rhythmic movement "bilateral priming" and its purpose is to ready the motor cortex for functional limb training. A "rocker" is used so that the less affected limb can drive the affected one in symmetrical wrist flexion and extension. The priming (15 minutes) will be following by task specific training (45 minutes). Subjects will then have a break (betw. 30-60 minutes) and then repeat the above. Total priming for one day is 30 minutes. Total task specific training for one day is 90 minutes
priming and task specific training: This task specific training protocol has been used in several clinical trials.
8
|
Health Education
n=7 Participants
The group with no priming will receive stroke related health education via a website from the American Heart Association (15 minutes). They will use their affected hand (as they are able) This will be followed by 45 minutes of the same task specific arm training protocol described in the bilateral priming group. This group will follow the same schedule as above. The health education (15 minutes) will be following by task specific training (45 minutes). Subjects will then have a break (betw. 30-60 minutes) and then repeat the above. Total time on health education website for one day is 30 minutes. Total task specific training for one day is 90 minutes
priming and task specific training: This task specific training protocol has been used in several clinical trials.
8
|
|---|---|---|
|
Change Score (Value at Follow-up - Value at Baseline) Fugl Meyer Upper Extremity Test of Function
|
10 units on a scale
Standard Error 2.5
|
4.3 units on a scale
Standard Error 1.67
|
Adverse Events
Bilateral Priming
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Care Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bilateral Priming
n=8 participants at risk
Experimental group: There are 2 parts to this behavioral intervention. Bilateral priming and task specific training Dosage: 15 minutes of bilateral priming per day 3/days per week for 5/wks. Also 45 minutes of task specific training is delivered 3/days per week for 5/wks. The total of 30 hours can be completed within 6 weeks.
Dosage frequency 2 times per day. Dosage type: Research participant must perform activities with affected hand (bilateral priming and task specific training) as directed by an occupational therapist
rec
|
Health Care Education
n=8 participants at risk
Active comparator : There are 2 parts to this behavioral intervention. Education on stroke health issues and task specific training. Health care education comes in the form of on-line games.
Dosage: 15 minutes per day of computerized education 3/days per week for 5/wks. Also 45 minutes of task specific training is delivered 3/days per week for 5/wks. The total of 30 hours can be completed within 6 weeks.
Dosage frequency 2 times per day for both parts of intervention Dosage type: Research participant must perform computerized education games as well as activities with the affected hand as directed by an occupational therapist
|
|---|---|---|
|
Infections and infestations
Hospitalization
|
12.5%
1/8 • Number of events 1 • 2 years
Adverse events reported to IRB
|
0.00%
0/8 • 2 years
Adverse events reported to IRB
|
Other adverse events
Adverse event data not reported
Additional Information
Mary Ellen Stoykov
now at Northwestern University, Department of PM&R
Phone: 312-503-3106
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place