Cerebrovascular Accident, Hemiplegia
Conditions
Keywords
Rehabilitation, Physical Therapy Techniques, Occupational Therapy, Upper Extremity; Motor skills
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALBilateral movements and neuromuscular 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.
BEHAVIORALBilateral movements and sham 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.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
44 Years to 86 Years
Healthy volunteers
No
Inclusion criteria
* an ability to complete 10º of wrist or finger extension from a 60 - 65 º flexed position * score less than a 56 on the UE subscale of the Fugl-Meyer Assessment * an ability to voluntarily activate slight movements in the wrist and fingers so that the EMG activity reaches a minimal level on the microprocessor for electrical stimulation to be activated * unilateral, first stroke of ischemic or hemorrhagic origin in the carotid artery distribution * free of major post stroke complications * able to attend therapy 2 days/week or 4 days/week for 2 weeks * score at least a 16 on the Mini Mental Status Examination * able to discriminate sharp from dull and light touch using traditional sensation tests.
Exclusion criteria
* hemiparetic arm is insensate * motor impairments from stroke on opposite side of body * pre-existing neurological disorders such as Parkinson's disease, Multiple Sclerosis, or dementia * Legal blindness or severe visual impairment; 5) Life expectancy less than one year * Severe arthritis or orthopedic problems that limit passive ranges of motion of upper extremity (passive finger extension \< 40º; passive wrist extension \< 40º; passive elbow extension \<40º; shoulder flexion/abduction \< 80º) * History of sustained alcoholism or drug abuse in the last six months * Has pacemaker or other implanted device * pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Box and Block Test; Data Collected = Number of Blocks Moved | Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8) | 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. |
| Fugl-Meyer Upper Extremity Motor Test | Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8) | 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. |
| Fractionated Reaction Time | Baseline/pretest; posttest given between days 17-22 (posttest days 3-8) | 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. |
Countries
United States
Participant flow
Recruitment details
Started August 2006 and ended June 2009
Pre-assignment details
Inability to voluntarily execute 10 degrees of wrist/finger extension from a 60-65 degrees flexed position.
Participants by arm
| Arm | Count |
|---|---|
| High Intensity Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks. | 10 |
| Low Intensity Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks. | 10 |
| Control Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation. | 10 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 4 | 5 | 7 |
Baseline characteristics
| Characteristic | Total | Low Intensity | High Intensity | Control |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 7 Participants | 6 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 3 Participants | 4 Participants | 5 Participants |
| Age Continuous | 65.2 years STANDARD_DEVIATION 6.6 | 67.2 years STANDARD_DEVIATION 6.8 | 65.3 years STANDARD_DEVIATION 8.1 | 61.8 years STANDARD_DEVIATION 2.6 |
| Region of Enrollment United States | 30 participants | 10 participants | 10 participants | 10 participants |
| Sex: Female, Male Female | 17 Participants | 6 Participants | 6 Participants | 5 Participants |
| Sex: Female, Male Male | 13 Participants | 4 Participants | 4 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Intensity | Box and Block Test; Data Collected = Number of Blocks Moved | Baseline/Pretest | 24.5 Blocks | Standard Deviation 22.1 |
| High Intensity | Box and Block Test; Data Collected = Number of Blocks Moved | Posttest | 27.5 Blocks | Standard Deviation 21.7 |
| Low Intensity | Box and Block Test; Data Collected = Number of Blocks Moved | Baseline/Pretest | 24.6 Blocks | Standard Deviation 12.7 |
| Low Intensity | Box and Block Test; Data Collected = Number of Blocks Moved | Posttest | 31.8 Blocks | Standard Deviation 12.6 |
| Control | Box and Block Test; Data Collected = Number of Blocks Moved | Baseline/Pretest | 40 Blocks | Standard Deviation 27.1 |
| Control | Box and Block Test; Data Collected = Number of Blocks Moved | Posttest | 42 Blocks | Standard Deviation 26.5 |
Comparison: Group by Test Session ANOVA with repeated measures on second factor.p-value: <0.0595% CI: [22.5, 37.4]Mixed Models Analysis
Primary
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)
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.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| High Intensity | Fractionated Reaction Time | Baseline/Pretest | 179 milliseconds | Standard Error 27.1 |
| High Intensity | Fractionated Reaction Time | Posttest | 170 milliseconds | Standard Error 22.8 |
| Low Intensity | Fractionated Reaction Time | Baseline/Pretest | 225 milliseconds | Standard Error 19.3 |
| Low Intensity | Fractionated Reaction Time | Posttest | 241 milliseconds | Standard Error 23.4 |
| Control | Fractionated Reaction Time | Baseline/Pretest | 135 milliseconds | Standard Error 5.6 |
| Control | Fractionated Reaction Time | Posttest | 161 milliseconds | Standard Error 5.4 |
Primary
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Intensity | Fugl-Meyer Upper Extremity Motor Test | Baseline/Pretest | 39 units on a scale | Standard Deviation 19.8 |
| High Intensity | Fugl-Meyer Upper Extremity Motor Test | Posttest | 42 units on a scale | Standard Deviation 17.1 |
| Low Intensity | Fugl-Meyer Upper Extremity Motor Test | Baseline/Pretest | 41 units on a scale | Standard Deviation 16.3 |
| Low Intensity | Fugl-Meyer Upper Extremity Motor Test | Posttest | 45 units on a scale | Standard Deviation 15.6 |
| Control | Fugl-Meyer Upper Extremity Motor Test | Baseline/Pretest | 53 units on a scale | Standard Deviation 9.7 |
| Control | Fugl-Meyer Upper Extremity Motor Test | Posttest | 56 units on a scale | Standard Deviation 6.9 |