Hemiparesis, Stroke, Stroke, Acute
Conditions
Keywords
stroke, recovery of function, functional electrical stimulation (FES)
Brief summary
Stroke is the leading cause of activity limitation among older adults in the United States. NeuroMuscular Electrical Stimulation (NMES) can assist stroke survivors in regaining motor ability and decreasing activity limitation caused by stroke. This study will research the effects of two types of NMES on reducing motor impairment and activity limitation.
Detailed description
Stroke is the leading cause of activity limitation among older adults in the United States. NeuroMuscular Electrical Stimulation (NMES) can be used by stroke survivors who do not have enough residual movement to take part in volitional active repetitive movement therapy and does not require expensive equipment or skilled personnel. Two types of NMES are available. The first is cyclic NMES, which electrically activates paretic muscles at a set duty cycle for a preset time period. (This study will employ both traditional cyclic stimulation and sensory-only stimulation, in which intensity is set at a level to be felt by the patient but insufficient to cause muscle contraction.)In cyclic NMES, the patient is a passive participant and does not assist the NMES by volitionally contracting the muscle during stimulation. The second type encompasses various forms of NMES in combination with biofeedback. For example, in EMG-triggered NMES, subjects are rewarded with stimulation in response to successful attempts to reach a pre-set level of EMG activity in the affected muscle. There is increased cognitive input and involvement on the part of the patient. The purpose of this study is to first demonstrate the effectiveness of these two types of surface stimulation on decreasing motor impairment and activity limitation; the study also seeks to assess the effect of adding cognitive input to NMES to reduce motor impairment and activity limitation. Study subjects will be acute stroke survivors. They will participate for a total of eight months, beginning within the first six months after their stroke. Subjects will be randomly assigned to one of three treatment groups and will receive stimulation accordingly: 1) Cyclic stimulation; 2)Sensory-only stimulation; and 3)EMG-triggered stimulation. Members of each treatment group will be given an appropriate NMES device to use for two 40-minute treatment sessions per day, five times per week for eight weeks; for a total of 80 treatment sessions. Stimulation will be applied to ECR and EDC (wrist and finger extensors) on the affected arm. A treatment therapist will visit the patient at home on a weekly basis to monitor subject compliance and to provide feedback on device usage. The primary outcome measure will be the upper extremity portion of the Fugl-Meyer Motor Assessment (FMA), a measure of motor impairment. The modified Arm Motor Ability Test (mAMAT) is a hemiparetic arm-specific measure of activity limitation, and will serve as a secondary outcome measure. In addition to the baseline visit on day of enrollment, subjects will complete these outcome measurements at the clinic on five other occasions: at mid-treatment (week 5); end of treatment (week 9); and for follow-up visits at one-, three- and six-months post-treatment.
Interventions
DEVICENMES device with EMG-triggered and Cyclic capabilities
All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Case Western Reserve University
MetroHealth Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Age 21-89 * Evidence of clinical symptoms from a hemorrhagic or nonhemorrhagic stroke with all symptoms from previous stroke(s) completely resolved * Medically stable * Less than 6 months post-stroke * Intact skin on the hemiparetic side * Able to follow 3-stage commands * Able to recall 2/3 objects after 30 minutes * Full passive ROM at the wrist and the thumb, index and long finger MCP joints on the affected side * Presence of a detectable, volitionally-activated EMG signal from the paretic wrist or finger extensors (ECR or EDC) * Affected wrist extensors ≤ 4 on MRC scale * Score of ≤ 11/14 on Section C (hand) of UE portion of Fugl Meyer Assessment (FMA) * Ability to tolerate NMES to the ECR and EDC for full wrist and finger extension * Caregiver available to assist with the device every day (unless subject capable of using it independently
Exclusion criteria
* History of ventricular arrythmias or any other arrythmias (i.e. fast atrial fibrillation, ventricular tachycardia, or supraventricular tachycardia) with hemodynamic instability * History of other upper motor neuron lesion * Absent sensation of the affected limb * Pregnancy * History of more than one seizure per month during the last year (or, since the stroke if no seizures prior to stroke) * Discharge to a skilled nursing facility or long-term care facility (EXCEPTION: Subjects may be d/c'd to the 6A SNF unit at MetroHealth Medical Center) * Uncompensated hemineglect * Implanted stimulator (such as a pacemaker) * Evidence of hand pain as defined by current metacarpophalangeal (MCP) joint pain upon palpation and/or wrist or MCP pain upon extension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure | FMA will be administered on 6 occasions: at baseline, mid-treatment, end of treatment, and follow-up at 1-,3- and 6-months post-treatment. | The FMA battery measures six dimensions of post-stroke impairment including upper and lower limb motor impairment, range of motion, pain, reflexes, and sensation. , Each item (33 total) is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and summed to provide a score ranging from 0 to 66, where higher scores indicate better motor function The FMA was administered with the participant seated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation | AMAT will be administered on 6 occasions as above: at baseline, mid-treatment, end of treatment, and follow-up at 1-,3- and 6-months post-treatment. | The AMAT assesses upper limb specific tasks and does not allow for compensation. The AMAT consists of 13 compound ADL tasks composed of 1 to 3 component tasks, with a total of 28 component tasks. Each task was rated on the functional ability ordinal scale from 0-5 and an average is calculated, so the final score remains 0-5, with higher scores indicating lesser activity limitation. Total range of reported data is between 0 and 5 because the average is reported. 0 refers to no function. 5 refers to normal function. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A. Cyclic Stim * Preprogrammed cycles of finger and thumb flexor and extensor stimulation (and flexor stimulation if deemed necessary by the PI) repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.
* Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles. | 39 |
| C. EMG-Triggered EMG-Triggered electrical stimulation. Subjects in this group will attempt to extend their affected wrist and fingers in response to an audio cue. They will be rewarded with stimulation to cause full hand opening once they have generated EMG sufficient to reach a preset threshold level.
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles. | 41 |
| B. Sensory Stim Sensory-only electrical stimulation. The stimulation will be cyclic in nature but intensity will be set to a level that can be felt by the patient but not sufficient to cause muscle contraction.
NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles. | 42 |
| Total | 122 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 8 | 11 | 7 |
| Overall Study | No category | 1 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 2 | 3 |
Baseline characteristics
| Characteristic | A. Cyclic Stim | C. EMG-Triggered | B. Sensory Stim | Total |
|---|---|---|---|---|
| Age, Continuous | 55.0 years | 58.6 years | 55.8 years | 55.1 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 40 Participants | 41 Participants | 119 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Months from Stroke | 2.0 months | 2.9 months | 3.2 months | 2.8 months |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 14 Participants | 9 Participants | 32 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 30 Participants | 27 Participants | 30 Participants | 87 Participants |
| Region of Enrollment United States | 39 participants | 41 participants | 42 participants | 122 participants |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 16 Participants | 51 Participants |
| Sex: Female, Male Male | 21 Participants | 24 Participants | 26 Participants | 71 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 | 1 / 39 | 3 / 41 | 2 / 42 |
| serious Total, serious adverse events | 10 / 39 | 13 / 41 | 9 / 42 |
Outcome results
Primary
Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure
The FMA battery measures six dimensions of post-stroke impairment including upper and lower limb motor impairment, range of motion, pain, reflexes, and sensation. , Each item (33 total) is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and summed to provide a score ranging from 0 to 66, where higher scores indicate better motor function The FMA was administered with the participant seated.
Time frame: FMA will be administered on 6 occasions: at baseline, mid-treatment, end of treatment, and follow-up at 1-,3- and 6-months post-treatment.
Population: All cases, intent-to-treat, adjusted for site
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| A. Cyclic Stim | Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure | Baseline | 27.5 units on a scale |
| A. Cyclic Stim | Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure | Mid Treatment | 31.8 units on a scale |
| A. Cyclic Stim | Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure | End of Treatment | 34.6 units on a scale |
| A. Cyclic Stim | Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure | 1 month after treatment | 33.6 units on a scale |
| A. Cyclic Stim | Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure | 3 months after treatment | 37.9 units on a scale |
| A. Cyclic Stim | Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure | 6 months after treatment | 39.3 units on a scale |
| C. EMG-Triggered | Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure | 6 months after treatment | 39.5 units on a scale |
| C. EMG-Triggered | Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure | Baseline | 29.8 units on a scale |
| C. EMG-Triggered | Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure | 1 month after treatment | 36.3 units on a scale |
| C. EMG-Triggered | Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure | 3 months after treatment | 39.3 units on a scale |
| C. EMG-Triggered | Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure | Mid Treatment | 32.6 units on a scale |
| C. EMG-Triggered | Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure | End of Treatment | 34.7 units on a scale |
| B. Sensory Stim | Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure | Mid Treatment | 30.4 units on a scale |
| B. Sensory Stim | Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure | End of Treatment | 33.6 units on a scale |
| B. Sensory Stim | Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure | 6 months after treatment | 37.6 units on a scale |
| B. Sensory Stim | Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure | 1 month after treatment | 35.2 units on a scale |
| B. Sensory Stim | Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure | Baseline | 26.8 units on a scale |
| B. Sensory Stim | Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure | 3 months after treatment | 37.3 units on a scale |
Comparison: The study was powered to detect differences in FMA scores of a minimum effect size of 0.8 at a significance level of 0.01, the smallest effect size difference anticipated between Cyclic NMES and Cyclic Sensory Stimulation based on prior studies. A significance level of 0.01 in the power-analysis was taken since for each measurement occasion, three post-hoc tests are needed. To account for drop out of 20 % , the minimum number of participants required per group is 63.p-value: 0.18Mixed Models Analysis
p-value: <0.001Mixed Models Analysis
Secondary
Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation
The AMAT assesses upper limb specific tasks and does not allow for compensation. The AMAT consists of 13 compound ADL tasks composed of 1 to 3 component tasks, with a total of 28 component tasks. Each task was rated on the functional ability ordinal scale from 0-5 and an average is calculated, so the final score remains 0-5, with higher scores indicating lesser activity limitation. Total range of reported data is between 0 and 5 because the average is reported. 0 refers to no function. 5 refers to normal function.
Time frame: AMAT will be administered on 6 occasions as above: at baseline, mid-treatment, end of treatment, and follow-up at 1-,3- and 6-months post-treatment.
Population: All cases, intent to treat
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| A. Cyclic Stim | Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation | Baseline | 1.7 units on a scale |
| A. Cyclic Stim | Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation | Mid Treatment | 2.2 units on a scale |
| A. Cyclic Stim | Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation | End of Treatment | 2.4 units on a scale |
| A. Cyclic Stim | Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation | 1 month after treatment | 2.6 units on a scale |
| A. Cyclic Stim | Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation | 3 months after treatment | 2.7 units on a scale |
| A. Cyclic Stim | Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation | 6 months after treatment | 2.9 units on a scale |
| C. EMG-Triggered | Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation | 6 months after treatment | 2.8 units on a scale |
| C. EMG-Triggered | Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation | Baseline | 2.0 units on a scale |
| C. EMG-Triggered | Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation | 1 month after treatment | 2.5 units on a scale |
| C. EMG-Triggered | Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation | 3 months after treatment | 2.8 units on a scale |
| C. EMG-Triggered | Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation | Mid Treatment | 2.3 units on a scale |
| C. EMG-Triggered | Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation | End of Treatment | 2.4 units on a scale |
| B. Sensory Stim | Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation | Mid Treatment | 2.0 units on a scale |
| B. Sensory Stim | Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation | End of Treatment | 2.1 units on a scale |
| B. Sensory Stim | Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation | 6 months after treatment | 2.7 units on a scale |
| B. Sensory Stim | Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation | 1 month after treatment | 2.3 units on a scale |
| B. Sensory Stim | Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation | Baseline | 1.7 units on a scale |
| B. Sensory Stim | Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation | 3 months after treatment | 2.5 units on a scale |
p-value: 0.27Mixed Models Analysis
p-value: <0.001Mixed Models Analysis