A Phase 2 interventional study of Bilateral movements and neuromuscular electrical stimulation and Bilateral movements and neuromuscular electrical stimulation in Cerebrovascular Accident and Hemiplegia, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 44 Years to 86 Years. Per ClinicalTrials.gov, last updated 2012-06-15.
Sponsored by University of Florida · Phase 2, Interventional, and Treatment
The purpose of this study was to determine the effect of two amounts of treatment therapy on post stroke motor recovery in the arms. The therapy is bilateral movement training combined with electrical stimulation on the impaired limb.
Intense movement training (practice) with the affected arm after stroke has the potential to improve upper extremity (UE) function resulting from neuroplasticity changes in the motor cortex. However, the necessary and sufficient parameters of this therapy in humans have not been fully investigated. Delineation of the most efficacious and efficient therapy for promoting UE recovery post-stroke is necessary before effective clinical implementation of this therapy. The current compared the effects on motor function impairments for three bilateral movement groups involving two doses of treatment (i.e., bilateral training coupled with neuromuscular electrical stimulation) and a sham control. During the subacute recovery phase (3 - 6 months), patients who meet motor capabilities criteria will be randomly assigned to one of three groups: (a) low intensity: 90 minutes/session, 2 sessions/week 2 weeks; bilateral movement training coupled with active neuromuscular stimulation on the impaired wrist/fingers; (b) high intensity: 90 minutes/session, 4 sessions/week for 2 weeks; bilateral movement training coupled with active stimulation on the impaired wrist/finger extensors; and (c) control group (sham active stimulation). Patients' UE motor capabilities were assessed before treatment therapy began (pretest) and within the first week after the treatment therapy ended (posttest).
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Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
Behavioral: Bilateral movements and neuromuscular electrical stimulation
Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
Behavioral: Bilateral movements and neuromuscular electrical stimulation
Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation
Behavioral: Bilateral movements and sham electrical stimulation
Participants practice moving their paretic arm at the same time as they move their non-paretic arm in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own contracting muscles is provided to the paretic arm during the movements. Training period was 4 times per week for 2 weeks.
Also known as: functional electrical stimulation
Participants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own contracting muscles is provided to the paretic arm during the movements. Training period was 2 times per week for 2 weeks.
Also known as: functional electrical stimulation
Participants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Sham electrical stimulation (low level electrical stimulation that can be felt but is insufficient to trigger a muscle contraction) is provided to the paretic arm during the movement. Training period was 2 times per week for 2 weeks.
Also known as: functional electrical stimulation - sham
Box and Block Test; Data Collected = Number of Blocks Moved
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.
Time frame: Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)
Fugl-Meyer Upper Extremity Motor Test
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.
Time frame: Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)
Fractionated Reaction Time
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.
Time frame: Baseline/pretest; posttest given between days 17-22 (posttest days 3-8)
Started August 2006 and ended June 2009
| Milestone | High Intensity | Low Intensity | Control |
|---|---|---|---|
| Started | 10 | 10 | 10 |
| Completed | 6 | 5 | 3 |
| Not completed | 4 | 5 | 7 |
| Withdrew: Lack of efficacy | 4 | 5 | 7 |
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.
| Blocks | High Intensity | Low Intensity | Control |
|---|---|---|---|
| Baseline/Pretest | 24.5 ± 22.1 | 24.6 ± 12.7 | 40 ± 27.1 |
| Posttest | 27.5 ± 21.7 | 31.8 ± 12.6 | 42 ± 26.5 |
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.
| units on a scale | High Intensity | Low Intensity | Control |
|---|---|---|---|
| Baseline/Pretest | 39 ± 19.8 | 41 ± 16.3 | 53 ± 9.7 |
| Posttest | 42 ± 17.1 | 45 ± 15.6 | 56 ± 6.9 |
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.
| milliseconds | High Intensity | Low Intensity | Control |
|---|---|---|---|
| Baseline/Pretest | 179 ± 27.1 | 225 ± 19.3 | 135 ± 5.6 |
| Posttest | 170 ± 22.8 | 241 ± 23.4 | 161 ± 5.4 |
Collected over 2 years, 10 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High Intensity | — | 0/10 (0%) | 0/10 (0%) |
| Low Intensity | — | 0/10 (0%) | 0/10 (0%) |
| Control | — | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | High Intensity | Low Intensity | Control | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 3 | 5 | 12 |
| >=65 years | 6 | 7 | 5 | 18 |
| Age Continuous(years) | High Intensity | Low Intensity | Control | Total |
|---|---|---|---|---|
| Mean | 65.3 ± 8.1 | 67.2 ± 6.8 | 61.8 ± 2.6 | 65.2 ± 6.6 |
| Sex: Female, Male(Participants) | High Intensity | Low Intensity | Control | Total |
|---|---|---|---|---|
| Female | 6 | 6 | 5 | 17 |
| Male | 4 | 4 | 5 | 13 |
| Region of Enrollment(participants) | High Intensity | Low Intensity | Control | Total |
|---|---|---|---|---|
| United States | 10 | 10 | 10 | 30 |
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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