An interventional study of Electrical Stimulator and Occupational Therapy in Stroke, Upper Extremity Paresis and Hemiplegia, sponsored by MetroHealth Medical Center. Completed at 4 sites in United States. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by MetroHealth Medical Center · Not applicable, Interventional, and Treatment
After a stroke, it is very common to lose the ability to open the affected hand. The purpose of this study is to compare the effects of three different therapies on recovery of hand function after stroke and determine if any one is better than the other.
A single-blinded randomized controlled trial will be carried out to assess and compare the effects of 12 weeks of Contralaterally Controlled Functional Electrical Stimulation (CCFES), Cyclic Neuromuscular Electrical Stimulation (cNMES), and Task Oriented Training. Dexterity, upper limb impairment, and activity limitation will be assessed at 0 (baseline), 12 (end of treatment), and 36 weeks. The treatment dose will be the same for all three groups: 10 sessions per week of self-administered treatment at home plus 2 sessions per week of group-specific occupational therapy in the lab.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 132 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
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Contralaterally Controlled Functional Electrical Stimulation (CCFES) uses an electrical stimulator and surface electrodes placed over the paretic finger and thumb extensors to deliver stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. Thus, volitional opening of the nonparetic hand produces stimulated opening of the paretic hand. During the lab visits, participants in the CCFES group will use CCFES to assist hand opening during occupational therapy task practice. During their home sessions, participants in the CCFES group will use CCFES to perform hand opening exercise.
Device: Electrical Stimulator · Behavioral: Occupational Therapy
Cyclic Neuromuscular Electrical Stimulation (cNMES) uses an electrical stimulator and surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation to open the weak hand. The stimulation automatically turns on and off causing the weak hand to open repetitively for several seconds at a time. During the lab visits, participants in the cNMES group will receive occupational therapy task practice. During their home sessions, participants in the cNMES group will use cNMES to perform hand opening exercise.
Device: Electrical Stimulator · Behavioral: Occupational Therapy
Task Oriented Therapy (TOT) focuses on practicing using the weak hand to practice activities of daily living tasks. During the clinic visits, participants in the TOT group will receive occupational therapy task practice. During their home sessions, participants in the TOT group will practice using their hand to complete a list of tasks given to them by the therapist to ensure that the participant receives a high dose of task practice.
Behavioral: Occupational Therapy
An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).
Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
Change in Box and Blocks Test (BBT) at 6 Months Post-Treatment
The BBT is a measure of hand dexterity. It is a count of how many blocks a patient can pick up, move over a barrier, and release in 60 seconds. The higher the score, the better the motor recovery.
Time frame: Baseline to 6 months post-treatment
Change in Upper Extremity Fugl Meyer (UEFM) at 6 Months Post-Treatment
The UEFM is a measure of upper limb motor impairment with a minimum score of 0 and maximum score of 66. The higher the score, the better the motor recovery.
Time frame: Baseline to 6 months post-treatment
Change in Action Research Arm Test (ARAT) at 6 Months Post-Treatment
The ARAT is a measure of arm and hand function with a minimum score of 0 and maximum score of 57. The higher the score, the better the motor recovery.
Time frame: Baseline to 6 months post-treatment
Change in Stroke Upper Limb Capacity Scale (SULCS) at 6 Months Post-Treatment
The SULCS is a measure of upper limb capacity with a minimum score of 0 and maximum score of 10. The higher the score, the better the motor recovery.
Time frame: Baseline to 6 months post-treatment
Responder Rate
Proportion of participants who had a gain of at least 6 points on the UEFM
Time frame: Baseline to 6 months post-treatment
| Milestone | CCFES | cNMES | Task Oriented Therapy |
|---|---|---|---|
| Started | 44 | 42 | 46 |
| Completed | 36 | 39 | 38 |
| Not completed | 8 | 3 | 8 |
The BBT is a measure of hand dexterity. It is a count of how many blocks a patient can pick up, move over a barrier, and release in 60 seconds. The higher the score, the better the motor recovery.
| blocks | CCFES | cNMES | Task Oriented Training |
|---|---|---|---|
| Change in Box and Blocks Test (BBT) at 6 Months Post-Treatment | 5.1 (3.4 to 6.7) | 4.2 (2.6 to 5.8) | 3.0 (1.4 to 4.6) |
The UEFM is a measure of upper limb motor impairment with a minimum score of 0 and maximum score of 66. The higher the score, the better the motor recovery.
| units on a scale | CCFES | cNMES | Task Oriented Training |
|---|---|---|---|
| Change in Upper Extremity Fugl Meyer (UEFM) at 6 Months Post-Treatment | 8.1 (6.1 to 10.1) | 3.7 (1.6 to 5.7) | 4.4 (2.4 to 6.4) |
The ARAT is a measure of arm and hand function with a minimum score of 0 and maximum score of 57. The higher the score, the better the motor recovery.
| units on a scale | CCFES | cNMES | Task Oriented Training |
|---|---|---|---|
| Change in Action Research Arm Test (ARAT) at 6 Months Post-Treatment | 5.8 (3.6 to 7.9) | 4.8 (2.7 to 7.0) | 1.7 (-0.4 to 3.8) |
The SULCS is a measure of upper limb capacity with a minimum score of 0 and maximum score of 10. The higher the score, the better the motor recovery.
| units on a scale | CCFES | cNMES | Task Oriented Training |
|---|---|---|---|
| Change in Stroke Upper Limb Capacity Scale (SULCS) at 6 Months Post-Treatment | 1.2 (0.7 to 1.7) | 0.8 (0.3 to 1.3) | 1.0 (0.5 to 1.5) |
Proportion of participants who had a gain of at least 6 points on the UEFM
| Participants | CCFES | cNMES | Task Oriented Training |
|---|---|---|---|
| Responder Rate | 22 | 13 | 13 |
Collected over Enrollment to 6 months post-treatment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CCFES | 0/44 (0%) | 0/44 (0%) | 5/44 (11.4%) |
| cNMES | 0/42 (0%) | 0/42 (0%) | 5/42 (11.9%) |
| Task Oriented Training | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
| Event | CCFES | cNMES | Task Oriented Training |
|---|---|---|---|
| Upper extremity pain possibly due to study-related increased use or overuseMusculoskeletal and connective tissue disorders | 3/44 | 5/42 | 0/46 |
| Transient discomfort from electrical stimulationInvestigations | 1/44 | 2/42 | 0/46 |
| Skin burn from stimulationInvestigations | 1/44 | 0/42 | 0/46 |
Participants who completed the treatment
| Age, Continuous(years) | CCFES | cNMES | Task Oriented Training | Total |
|---|---|---|---|---|
| Mean | 58.7 ± 10.9 | 58.9 ± 13.7 | 60.6 ± 12.5 | 59.4 ± 12.4 |
| Sex: Female, Male(Participants) | CCFES | cNMES | Task Oriented Training | Total |
|---|---|---|---|---|
| Female | 13 | 17 | 9 | 39 |
| Male | 23 | 22 | 29 | 74 |
| Race/Ethnicity, Customized(Participants) | CCFES | cNMES | Task Oriented Training | Total |
|---|---|---|---|---|
| African American | 5 | 8 | 9 | 22 |
| White | 23 | 24 | 23 | 70 |
| Asian | 6 | 2 | 3 | 11 |
| Unknown or Chose Not To Answer | 2 | 2 | 0 | 4 |
| More than One Race | 0 | 2 | 3 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 1 |
| Region of Enrollment(participants) | CCFES | cNMES | Task Oriented Training | Total |
|---|---|---|---|---|
| United States | 36 | 39 | 38 | 113 |
| Time Since Stroke(months) | CCFES | cNMES | Task Oriented Training | Total |
|---|---|---|---|---|
| Mean | 12.4 ± 5.3 | 13.5 ± 5.1 | 13.5 ± 5.5 | 13.1 ± 5.3 |
| Hand Weakness(Participants) | CCFES | cNMES | Task Oriented Training | Total |
|---|---|---|---|---|
| Moderate | 18 | 21 | 19 | 58 |
| Severe | 18 | 18 | 19 | 55 |
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