Trial Outcomes & Findings for Post Stroke Hand Functions: Bilateral Movements and Electrical Stimulation Treatments (NCT NCT00369668)

Results Overview

A 60 second timed hand/arm manipulation test in which participants reach, grasp, lift, and release a 1" x 1" block of wood. They must lift a block from one side of a box, carry it over a low barrier and release the block into the other side of the box.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)

Results posted on

2012-06-15

Participant Flow

Started August 2006 and ended June 2009

Inability to voluntarily execute 10 degrees of wrist/finger extension from a 60-65 degrees flexed position.

Participant milestones

Participant milestones
Measure	High Intensity Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.	Low Intensity Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.	Control Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation.
Overall Study STARTED	10	10	10
Overall Study COMPLETED	6	5	3
Overall Study NOT COMPLETED	4	5	7

Reasons for withdrawal

Reasons for withdrawal
Measure	High Intensity Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.	Low Intensity Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.	Control Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation.
Overall Study Lack of Efficacy	4	5	7

Baseline Characteristics

Post Stroke Hand Functions: Bilateral Movements and Electrical Stimulation Treatments

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Intensity n=10 Participants Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.	Low Intensity n=10 Participants Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.	Control n=10 Participants Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation.	Total n=30 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	18 Participants n=4 Participants
Age Continuous	65.3 years STANDARD_DEVIATION 8.1 • n=5 Participants	67.2 years STANDARD_DEVIATION 6.8 • n=7 Participants	61.8 years STANDARD_DEVIATION 2.6 • n=5 Participants	65.2 years STANDARD_DEVIATION 6.6 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	13 Participants n=4 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	30 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)

Population: All participants who completed the bilateral training protocols were submitted to statistical analysis. Data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment.

A 60 second timed hand/arm manipulation test in which participants reach, grasp, lift, and release a 1" x 1" block of wood. They must lift a block from one side of a box, carry it over a low barrier and release the block into the other side of the box.

Outcome measures

Outcome measures
Measure	High Intensity n=6 Participants Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.	Low Intensity n=5 Participants Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.	Control n=3 Participants Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation
Box and Block Test; Data Collected = Number of Blocks Moved Baseline/Pretest	24.5 Blocks Standard Deviation 22.1	24.6 Blocks Standard Deviation 12.7	40 Blocks Standard Deviation 27.1
Box and Block Test; Data Collected = Number of Blocks Moved Posttest	27.5 Blocks Standard Deviation 21.7	31.8 Blocks Standard Deviation 12.6	42 Blocks Standard Deviation 26.5

PRIMARY outcome

Timeframe: Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)

Population: All participants who completed the bilateral training protocols were submitted to statistical analysis. Data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment.

FM motor test assesses functional impairments post stroke as participants attempt various movements from daily activities. Minimum score = 0; maximum score = 66; lower scores indicate more impairments and higher scores indicate less impairments.

Outcome measures

Outcome measures
Measure	High Intensity n=6 Participants Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.	Low Intensity n=5 Participants Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.	Control n=3 Participants Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation
Fugl-Meyer Upper Extremity Motor Test Baseline/Pretest	39 units on a scale Standard Deviation 19.8	41 units on a scale Standard Deviation 16.3	53 units on a scale Standard Deviation 9.7
Fugl-Meyer Upper Extremity Motor Test Posttest	42 units on a scale Standard Deviation 17.1	45 units on a scale Standard Deviation 15.6	56 units on a scale Standard Deviation 6.9

PRIMARY outcome

Timeframe: Baseline/pretest; posttest given between days 17-22 (posttest days 3-8)

Population: All participants who completed the bilateral training protocols were submitted to statistical analysis. Premotor reaction data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment.

Premotor reaction times in milliseconds were recorded for the impaired arm of each participant in the three intervention (arm) groups. Premotor reaction time represents central processes. Lower times are faster reaction times, indicating less time to initiate a movement.

Outcome measures

Outcome measures
Measure	High Intensity n=6 Participants Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.	Low Intensity n=5 Participants Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.	Control n=3 Participants Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation
Fractionated Reaction Time Baseline/Pretest	179 milliseconds Standard Error 27.1	225 milliseconds Standard Error 19.3	135 milliseconds Standard Error 5.6
Fractionated Reaction Time Posttest	170 milliseconds Standard Error 22.8	241 milliseconds Standard Error 23.4	161 milliseconds Standard Error 5.4

Adverse Events

High Intensity

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Intensity

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James Cauraugh, Ph.D., PI

University of Florida, Motor Behavior Laboratory

Phone: 352-294-1623

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place