Hemiplegia, Stroke, Upper Extremity Paresis
Conditions
Keywords
stroke, rehabilitation, therapy, electrical stimulation, hand
Brief summary
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.
Detailed description
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.
Interventions
DEVICEElectrical Stimulator
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).
BEHAVIORALOccupational Therapy
Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
Sponsors
MetroHealth Medical Center
Kessler Foundation
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Cleveland Clinic
Johns Hopkins University
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 6 to 24 months since a first clinical cortical or subcortical, hemorrhagic or nonhemorrhagic stroke * unilateral upper limb hemiparesis with finger extensor strength of grade no more than 4 out of 5 on the Medical Research Council (MRC) scale * score of at least 1 and no more than 11 out of 14 on the hand section of the upper extremity Fugl-Meyer Assessment * adequate active movement of the shoulder and elbow to position the hand in the workspace for table-top task practice (necessary for the lab task practice sessions) * able to follow 3-stage commands * able to recall at least 2 of a list of 3 items after 30 minutes * skin intact on the hemiparetic arm * surface stimulation of the paretic finger and thumb extensors produces functional hand opening without pain (this will exclude those who have too much flexor spasticity) * able to hear and respond to cues from stimulator * not receiving occupational therapy (no concomitant OT) * full voluntary opening/closing of the contralateral (less affected) hand * demonstrates ability to follow instructions for operating the stimulator or have a caregiver who will assist them
Exclusion criteria
* co-existing neurologic diagnosis of peripheral nerve injury, Parkinson's disease, spinal cord injury, traumatic brain injury, or multiple sclerosis * uncontrolled seizure disorder * brainstem stroke * uncompensated hemineglect * severe shoulder or hand pain * insensate forearm or hand * history of potentially fatal cardiac arrhythmias with hemodynamic instability * implanted electronic systems (e.g. pacemaker) * botulinum toxin injections to any upper extremity muscle within 3 months of enrolling * pregnant women due to unknown risks of surface NMES during pregnancy * lack of functional passive range of motion of the wrist or fingers of affected side * diagnosis (apart from stroke) that substantially affects paretic arm and hand function * deficits in communication that interfere with reasonable study participation * lacking sufficient visual acuity to see the stimulator's display * concurrent enrollment in another investigational study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Box and Blocks Test (BBT) at 6 Months Post-Treatment | Baseline to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Upper Extremity Fugl Meyer (UEFM) at 6 Months Post-Treatment | Baseline to 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. |
| Change in Action Research Arm Test (ARAT) at 6 Months Post-Treatment | Baseline to 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. |
| Change in Stroke Upper Limb Capacity Scale (SULCS) at 6 Months Post-Treatment | Baseline to 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. |
| Responder Rate | Baseline to 6 months post-treatment | Proportion of participants who had a gain of at least 6 points on the UEFM |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJayme Knutson, PhD
MetroHealth Medical Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 59.4 years STANDARD_DEVIATION 12.4 |
| Hand Weakness Moderate | 21 Participants |
| Hand Weakness Severe | 18 Participants |
| Race/Ethnicity, Customized African American | 22 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized More than One Race | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Unknown or Chose Not To Answer | 2 Participants |
| Race/Ethnicity, Customized White | 70 Participants |
| Region of Enrollment United States | 113 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 23 Participants |
| Time Since Stroke | 13.1 months STANDARD_DEVIATION 5.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 42 | 0 / 46 |
| other Total, other adverse events | 5 / 44 | 5 / 42 | 0 / 46 |
| serious Total, serious adverse events | 0 / 44 | 0 / 42 | 0 / 46 |
Outcome results
None listed