Trial Outcomes & Findings for Combined Neural and Behavioral Therapies to Enhance Stroke Recovery (NCT NCT00929656)
NCT ID: NCT00929656
Last Updated: 2017-08-21
Results Overview
Change, in seconds, between Pre-intervention and post-intervention (4 wks following pre-intervention). The time to complete 15 separate upper extremity functional tasks are recorded. These 15 separate timed events are averaged to provide one time, in seconds. This is considered an Activity Measure on the WHO ICF model.
COMPLETED
NA
22 participants
Change between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)
2017-08-21
Participant Flow
Participants were recruited from the Malcom Randall VA Brain Rehabilitation Research Center database from 2/1/13-9/30/15
Participant milestones
| Measure |
Unimanual UE Training + Real rTMS
Unimanual Upper Extremity (UE) training + repetitive Transcranial Magnetic Stimulation (rTMS)
Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)
|
Unimanual UE Training + Sham rTMS
Unimanual Upper Extremity (UE) training + sham repetitive Transcranial Magnetic Stimulation (rTMS)
Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
9
|
|
Overall Study
COMPLETED
|
13
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Unimanual UE Training + Real rTMS
Unimanual Upper Extremity (UE) training + repetitive Transcranial Magnetic Stimulation (rTMS)
Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)
|
Unimanual UE Training + Sham rTMS
Unimanual Upper Extremity (UE) training + sham repetitive Transcranial Magnetic Stimulation (rTMS)
Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Combined Neural and Behavioral Therapies to Enhance Stroke Recovery
Baseline characteristics by cohort
| Measure |
Unimanual UE Training + Real rTMS
n=13 Participants
Participants randomized to the Experimental Arm received real rTMS (1000 pulses) to their ipsilesional hemisphere followed by two hours of paretic arm functional task practice administered/supervised by a physical therapist.
|
Unimanual UE Training + Sham rTMS
n=9 Participants
Participants randomized to the Placebo Arm received sham rTMS to their ipsilesional hemisphere followed by two hours of paretic arm functional task practice administered/supervised by a physical therapist.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 10.0 • n=93 Participants
|
59.4 years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
60.5 years
STANDARD_DEVIATION 9.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Time Post-Stroke
|
44.0 months
STANDARD_DEVIATION 95.6 • n=93 Participants
|
33.3 months
STANDARD_DEVIATION 25.9 • n=4 Participants
|
39.6 months
STANDARD_DEVIATION 74.2 • n=27 Participants
|
PRIMARY outcome
Timeframe: Change between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)Change, in seconds, between Pre-intervention and post-intervention (4 wks following pre-intervention). The time to complete 15 separate upper extremity functional tasks are recorded. These 15 separate timed events are averaged to provide one time, in seconds. This is considered an Activity Measure on the WHO ICF model.
Outcome measures
| Measure |
Unimanual UE Training + Real rTMS
n=13 Participants
Unimanual UE training + rTMS
Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)
|
Unimanual UE Training + Sham rTMS
n=9 Participants
Unimanual UE training + sham rTMS
Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)
|
|---|---|---|
|
Wolf Motor Function Test Change
|
1.6 seconds
Standard Error 1.1
|
1.8 seconds
Standard Error 1.2
|
SECONDARY outcome
Timeframe: Change Between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)Change in Score from Pre-intervention to Post-Intervention. This outcome measures arm motor control; the ability to move outside of pathologic synergistic patterns. It is a measure of impairment in Body Structure/Function. Total score ranges from 0-66, with 0 indicative of no movement and 66 considered normal motor control.
Outcome measures
| Measure |
Unimanual UE Training + Real rTMS
n=13 Participants
Unimanual UE training + rTMS
Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)
|
Unimanual UE Training + Sham rTMS
n=9 Participants
Unimanual UE training + sham rTMS
Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)
|
|---|---|---|
|
Upper Extremity Fugl-Meyer Motor Assessment Change
|
5.8 units on a scale
Standard Error 1.4
|
5.8 units on a scale
Standard Error 1.1
|
SECONDARY outcome
Timeframe: Change between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)Change in Paretic hand grip strength from pre- to post-intervention. Grip strength measured by hand-held dynamometer. An average of 3 5-second trials was used for analysis.
Outcome measures
| Measure |
Unimanual UE Training + Real rTMS
n=13 Participants
Unimanual UE training + rTMS
Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)
|
Unimanual UE Training + Sham rTMS
n=9 Participants
Unimanual UE training + sham rTMS
Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)
|
|---|---|---|
|
Grip Strength Change
|
1.1 kilograms
Standard Error 2.0
|
1.3 kilograms
Standard Error 2.4
|
SECONDARY outcome
Timeframe: Change Between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)Self-Report Amount of Use of Paretic UE to complete 30 functional tasks. Each task is reported on a 0-5 scale with "0" representing "did not use my paretic hand at all for that task" and "5" representing "I used my paretic hand as much as before the stroke to complete that task." A "5" on each task would be considered "normal."
Outcome measures
| Measure |
Unimanual UE Training + Real rTMS
n=13 Participants
Unimanual UE training + rTMS
Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)
|
Unimanual UE Training + Sham rTMS
n=9 Participants
Unimanual UE training + sham rTMS
Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)
|
|---|---|---|
|
Motor Activity Log - Amount of Use Change
|
1.3 Units on a scale
Standard Error 0.3
|
1.2 Units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Change between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)Self-Report of How Well paretic UE performed completing 30 functional tasks. Each task is reported on a 0-5 scale with "0" representing "Unable to use my paretic hand to perform that task" and "5" representing "My paretic hand performs that task as well as it did before the stroke." A "5" on each task would be considered "normal."
Outcome measures
| Measure |
Unimanual UE Training + Real rTMS
n=13 Participants
Unimanual UE training + rTMS
Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)
|
Unimanual UE Training + Sham rTMS
n=9 Participants
Unimanual UE training + sham rTMS
Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)
|
|---|---|---|
|
Motor Activity Log - How Well Change
|
1.1 Units on a scale
Standard Error 0.3
|
1.2 Units on a scale
Standard Error 0.4
|
Adverse Events
Unimanual UE Training + Real rTMS
Unimanual UE Training + Sham rTMS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Dorian Rose, Research Health Scientist
Malcom Randall VAMC
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place