Trial Outcomes & Findings for Contralaterally Controlled FES of Arm & Hand for Subacute Stroke Rehabilitation (NCT NCT01688856)
NCT ID: NCT01688856
Last Updated: 2020-01-09
Results Overview
The BBT counts how many blocks a participant can pick up, move over a barrier, and release in 60 seconds. Higher scores mean a better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
2 timepoints: prior to treatment, 6 months post-treatment
Results posted on
2020-01-09
Participant Flow
Participant milestones
| Measure |
Arm+Hand CCFES
Uses an electrical stimulator that opens the paretic hand and extends the paretic elbow in response to and with an intensity proportional to movement of the contralateral arm and hand.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session.
|
Hand CCFES
Uses an electrical stimulator that opens the paretic hand in response to and with an intensity proportional to movement of the contralateral hand.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session.
|
Arm+Hand Cyclic NMES
Uses an electrical stimulator that delivers stimulation to open the hand and extend the elbow repeatedly with preprogrammed timing and intensity.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided task practice performed 70 minutes twice a week in the research laboratory. (Stimulator not used during these sessions. To ensure that all 3 groups receive an equivalent dose of stimulation, this group has slightly lengthened self-administered hand opening exercise sessions at home.)
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 60 min/session.
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
11
|
|
Overall Study
COMPLETED
|
21
|
24
|
8
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Contralaterally Controlled FES of Arm & Hand for Subacute Stroke Rehabilitation
Baseline characteristics by cohort
| Measure |
Arm+Hand CCFES
n=28 Participants
Uses an electrical stimulator that opens the paretic hand and extends the paretic elbow in response to and with an intensity proportional to movement of the contralateral arm and hand.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session.
|
Hand CCFES
n=28 Participants
Uses an electrical stimulator that opens the paretic hand in response to and with an intensity proportional to movement of the contralateral hand.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session.
|
Arm+Hand Cyclic NMES
n=11 Participants
Uses an electrical stimulator that delivers stimulation to open the hand and extend the elbow repeatedly with preprogrammed timing and intensity.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided task practice performed 70 minutes twice a week in the research laboratory. (Stimulator not used during these sessions. To ensure that all 3 groups receive an equivalent dose of stimulation, this group has slightly lengthened self-administered hand opening exercise sessions at home.)
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 60 min/session.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 12.6 • n=93 Participants
|
60 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
61 years
STANDARD_DEVIATION 12.5 • n=27 Participants
|
58 years
STANDARD_DEVIATION 12.5 • n=483 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
43 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
13 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White
|
13 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
41 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 2 timepoints: prior to treatment, 6 months post-treatmentThe BBT counts how many blocks a participant can pick up, move over a barrier, and release in 60 seconds. Higher scores mean a better outcome.
Outcome measures
| Measure |
Arm+Hand CCFES
n=21 Participants
Uses an electrical stimulator that opens the paretic hand and extends the paretic elbow in response to and with an intensity proportional to movement of the contralateral arm and hand.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session.
|
Hand CCFES
n=24 Participants
Uses an electrical stimulator that opens the paretic hand in response to and with an intensity proportional to movement of the contralateral hand.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session.
|
Arm+Hand Cyclic NMES
n=8 Participants
Uses an electrical stimulator that delivers stimulation to open the hand and extend the elbow repeatedly with preprogrammed timing and intensity.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided task practice performed 70 minutes twice a week in the research laboratory. (Stimulator not used during these sessions. To ensure that all 3 groups receive an equivalent dose of stimulation, this group has slightly lengthened self-administered hand opening exercise sessions at home.)
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 60 min/session.
|
|---|---|---|---|
|
Change in Box and Block Test (BBT) Score at 6 Months Post-Treatment
|
13.5 blocks
Interval 6.4 to 20.6
|
12.6 blocks
Interval 7.4 to 17.7
|
9.6 blocks
Interval 2.6 to 16.7
|
SECONDARY outcome
Timeframe: 2 timepoints: prior to treatment, 6 months post-treatmentReachable Workspace (RW) is the area (cm\^2) traced out when reaching for a target moving in a circular path just outside the reach of the participant.
Outcome measures
| Measure |
Arm+Hand CCFES
n=21 Participants
Uses an electrical stimulator that opens the paretic hand and extends the paretic elbow in response to and with an intensity proportional to movement of the contralateral arm and hand.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session.
|
Hand CCFES
n=24 Participants
Uses an electrical stimulator that opens the paretic hand in response to and with an intensity proportional to movement of the contralateral hand.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session.
|
Arm+Hand Cyclic NMES
n=8 Participants
Uses an electrical stimulator that delivers stimulation to open the hand and extend the elbow repeatedly with preprogrammed timing and intensity.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided task practice performed 70 minutes twice a week in the research laboratory. (Stimulator not used during these sessions. To ensure that all 3 groups receive an equivalent dose of stimulation, this group has slightly lengthened self-administered hand opening exercise sessions at home.)
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 60 min/session.
|
|---|---|---|---|
|
Change in Reachable Workspace (RW) at 6 Months Post-Treatment
|
430 squared centimeters
Interval 221.0 to 639.0
|
166 squared centimeters
Interval 55.0 to 276.0
|
152 squared centimeters
Interval 4.0 to 300.0
|
SECONDARY outcome
Timeframe: 2 timepoints: prior to treatment, 6 months post-treatmentThe Upper Extremity Fugl-Meyer (UEFM) is an assessment of motor impairment of the upper limb in which the participant is asked to make specific movements of the arm, forearm, wrist, and hand. Each movement is scored 0, 1, or 2 and the subscores are summed. Min=0; Max=66. Higher scores mean a better outcome.
Outcome measures
| Measure |
Arm+Hand CCFES
n=21 Participants
Uses an electrical stimulator that opens the paretic hand and extends the paretic elbow in response to and with an intensity proportional to movement of the contralateral arm and hand.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session.
|
Hand CCFES
n=24 Participants
Uses an electrical stimulator that opens the paretic hand in response to and with an intensity proportional to movement of the contralateral hand.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session.
|
Arm+Hand Cyclic NMES
n=8 Participants
Uses an electrical stimulator that delivers stimulation to open the hand and extend the elbow repeatedly with preprogrammed timing and intensity.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided task practice performed 70 minutes twice a week in the research laboratory. (Stimulator not used during these sessions. To ensure that all 3 groups receive an equivalent dose of stimulation, this group has slightly lengthened self-administered hand opening exercise sessions at home.)
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 60 min/session.
|
|---|---|---|---|
|
Change in Upper Extremity Fugl-Meyer (UEFM) Score at 6 Months Post-Treatment
|
11.0 units on a scale
Interval 6.1 to 16.0
|
4.4 units on a scale
Interval 0.9 to 7.9
|
10.7 units on a scale
Interval 8.2 to 13.2
|
SECONDARY outcome
Timeframe: 2 timepoints: prior to treatment, 6 months post-treatmentStroke Upper Limb Capacity Scale (SULCS) is a 10-item test in which participants are given a score of 0 or 1 on their performance of tasks requiring varying degrees of upper limb capacity. Min=0; Max=10. Higher scores mean a better outcome.
Outcome measures
| Measure |
Arm+Hand CCFES
n=21 Participants
Uses an electrical stimulator that opens the paretic hand and extends the paretic elbow in response to and with an intensity proportional to movement of the contralateral arm and hand.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session.
|
Hand CCFES
n=24 Participants
Uses an electrical stimulator that opens the paretic hand in response to and with an intensity proportional to movement of the contralateral hand.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session.
|
Arm+Hand Cyclic NMES
n=8 Participants
Uses an electrical stimulator that delivers stimulation to open the hand and extend the elbow repeatedly with preprogrammed timing and intensity.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided task practice performed 70 minutes twice a week in the research laboratory. (Stimulator not used during these sessions. To ensure that all 3 groups receive an equivalent dose of stimulation, this group has slightly lengthened self-administered hand opening exercise sessions at home.)
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 60 min/session.
|
|---|---|---|---|
|
Change in Stroke Upper Limb Capacity Scale (SULCS) at 6 Months Post-Treatment
|
2.6 units on a scale
Interval 1.2 to 3.9
|
1.5 units on a scale
Interval 0.7 to 2.4
|
1.9 units on a scale
Interval 1.1 to 2.8
|
SECONDARY outcome
Timeframe: 2 timepoints: prior to treatment, 6 months post-treatmentThe Arm Motor Abilities Test (AMAT) is an assessment of the participant's ability to do 9 standardized upper limb tasks. Each task is composed of 1 to 3 component tasks, each of which is rated on an ordinal scale of 0 to 5. The final score is the average of all component task scores across all 9 compound tasks. Min=0; Max=5. Higher scores mean a better outcome.
Outcome measures
| Measure |
Arm+Hand CCFES
n=21 Participants
Uses an electrical stimulator that opens the paretic hand and extends the paretic elbow in response to and with an intensity proportional to movement of the contralateral arm and hand.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session.
|
Hand CCFES
n=24 Participants
Uses an electrical stimulator that opens the paretic hand in response to and with an intensity proportional to movement of the contralateral hand.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session.
|
Arm+Hand Cyclic NMES
n=8 Participants
Uses an electrical stimulator that delivers stimulation to open the hand and extend the elbow repeatedly with preprogrammed timing and intensity.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided task practice performed 70 minutes twice a week in the research laboratory. (Stimulator not used during these sessions. To ensure that all 3 groups receive an equivalent dose of stimulation, this group has slightly lengthened self-administered hand opening exercise sessions at home.)
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 60 min/session.
|
|---|---|---|---|
|
Change in Arm Motor Abilities Test (AMAT) at 6 Months Post-Treatment
|
1.0 units on a scale
Interval 0.5 to 1.6
|
0.8 units on a scale
Interval 0.6 to 1.1
|
0.9 units on a scale
Interval 0.5 to 1.4
|
Adverse Events
Arm+Hand CCFES
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Hand CCFES
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm+Hand Cyclic NMES
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm+Hand CCFES
n=28 participants at risk
Uses an electrical stimulator that opens the paretic hand and extends the paretic elbow in response to and with an intensity proportional to movement of the contralateral arm and hand.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session.
|
Hand CCFES
n=28 participants at risk
Uses an electrical stimulator that opens the paretic hand in response to and with an intensity proportional to movement of the contralateral hand.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory.
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session.
|
Arm+Hand Cyclic NMES
n=11 participants at risk
Uses an electrical stimulator that delivers stimulation to open the hand and extend the elbow repeatedly with preprogrammed timing and intensity.
Electrical stimulator: The 12-week treatment period consists of two components:
1. Therapist-guided task practice performed 70 minutes twice a week in the research laboratory. (Stimulator not used during these sessions. To ensure that all 3 groups receive an equivalent dose of stimulation, this group has slightly lengthened self-administered hand opening exercise sessions at home.)
2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 60 min/session.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Shoulder pain related to RW assessment
|
7.1%
2/28 • From enrollment to 6-month post-treatment outcome assessment.
|
17.9%
5/28 • From enrollment to 6-month post-treatment outcome assessment.
|
18.2%
2/11 • From enrollment to 6-month post-treatment outcome assessment.
|
|
Musculoskeletal and connective tissue disorders
Numbness and Tingling in Both Hands
|
3.6%
1/28 • From enrollment to 6-month post-treatment outcome assessment.
|
0.00%
0/28 • From enrollment to 6-month post-treatment outcome assessment.
|
0.00%
0/11 • From enrollment to 6-month post-treatment outcome assessment.
|
|
Musculoskeletal and connective tissue disorders
Abdominal Pain During RW Assessment
|
0.00%
0/28 • From enrollment to 6-month post-treatment outcome assessment.
|
7.1%
2/28 • From enrollment to 6-month post-treatment outcome assessment.
|
0.00%
0/11 • From enrollment to 6-month post-treatment outcome assessment.
|
|
Musculoskeletal and connective tissue disorders
Transient Discomfort from Stimulation
|
3.6%
1/28 • From enrollment to 6-month post-treatment outcome assessment.
|
0.00%
0/28 • From enrollment to 6-month post-treatment outcome assessment.
|
0.00%
0/11 • From enrollment to 6-month post-treatment outcome assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place