N/A
N=80
Electrical Stimulation for Recovery of Hand Function in Chronic Stroke Survivors
Stroke · Hemiparesis · Hemiplegia
Bottom Line
View on ClinicalTrials.gov: NCT00891319 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Change in Box and Block Test Score at 6 Mo Post-Treatment — 4.6; 1.8 blocks
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Electrical stimulator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MetroHealth Medical Center
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Box and Block Test Score at 6 Mo Post-Treatment |
4.6; 1.8 | — |
| SECONDARY Change in Arm Motor Abilities Test Score at 6-Month Post-Treatment |
0.18; 0.04 | — |
| SECONDARY Change in Upper Extremity Fugl-Meyer Score at 6-Months Post-Treatment |
2.4; 2.2 | — |
Summary
Impaired hand function is one of the most frequently persisting consequences of stroke. The purpose of this study is to compare two different treatments -- Contralataterally Controlled Functional Electrical Stimulation (CCFES) and Cyclic Neuromuscular Electrical Stimulation (cNMES) -- for improved recovery of hand function after stroke.
Eligibility Criteria
Inclusion Criteria
- Age 18-80
- > 6 months of first hemorrhagic or nonhemorrhagic stroke
- Able to recall 2 of 3 items after 30 minutes
- MRC ≤ 4 for finger extensors on paretic side
- Able to follow 3-stage commands
- Functional movement of shoulder and elbow (e.g., can reach ¾ hand-to- mouth movement) of paretic side
- Caregiver available to assist with device and compliance if needed
- Skin intact on hemiparetic arm
- Medically stable
- Surface NMES trial opens hand without pain
- Full volitional hand opening/closing of contralateral hand
- Upper extremity hand section of FMA < 11/14
- Able to hear and respond to stimulator/cue box auditory cues
- Completed occupational therapy (no concomitant OT)
Exclusion Criteria
- Lack of functional PROM of the wrist or fingers of affected side
- Severe shoulder or hand pain (unable to position hand in the workspace without pain)
- Uncontrolled seizure disorder
- Insensate forearm and/or hand
- Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
- Edema of the affected forearm and/or hand
- History of cardiac arrhythmias with hemodynamic instability
- Cardiac pacemaker or other implanted electronic system
- Pregnant
- IM Botox injections in any UE muscle in the last 3 months
- Parkinson's disease, SCI, TBI, or MS
- Ipsilateral motor neuron lesion
Data sourced from ClinicalTrials.gov (NCT00891319). 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.