N/A
N=132
Therapies for Recovery of Hand Function After Stroke
Stroke · Upper Extremity Paresis · Hemiplegia
Bottom Line
View on ClinicalTrials.gov: NCT03574623 ↗Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Change in Box and Blocks Test (BBT) at 6 Months Post-Treatment — 5.1; 4.2; 3.0 blocks
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Electrical Stimulator (Device); Occupational Therapy (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- MetroHealth Medical Center
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Box and Blocks Test (BBT) at 6 Months Post-Treatment |
5.1; 4.2; 3.0 | — |
| SECONDARY Change in Upper Extremity Fugl Meyer (UEFM) at 6 Months Post-Treatment |
8.1; 3.7; 4.4 | — |
| SECONDARY Change in Action Research Arm Test (ARAT) at 6 Months Post-Treatment |
5.8; 4.8; 1.7 | — |
| SECONDARY Change in Stroke Upper Limb Capacity Scale (SULCS) at 6 Months Post-Treatment |
1.2; 0.8; 1.0 | — |
| SECONDARY Responder Rate |
22; 13; 13 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03574623). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.