Clinical trial NCT00891319: Electrical Stimulation for Recovery of Hand Function in Chronic Stroke Survivors
Official title: Contralaterally Controlled FES for Chronic Arm/Hand Hemiplegia: Single-Site RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiparesis
Hemiplegia
Keywords: hand
stroke
hemiplegia
electrical stimulation
recovery
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Case Western Reserve University
First posted: 2009-05-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Hemiparesis of the upper limb is one of the most serious and most common impairments resulting from stroke. Approximately 75% of the over 750,000 strokes that occur annually in the United States cause some degree of upper extremity paralysis. Approximately 65% of stroke survivors still cannot use their affected hand to assist with activities of daily living 6 months after their stroke. The impact of upper extremity impairments on disability and health is great, yet there are relatively few rehabilitation interventions designed to restore function to the impaired upper limb. Therefore, our long-term objective is to develop upper extremity rehabilitation therapies that are effective at restoring arm and hand function, that are applicable across a wide range of impairment severity, and that are readily implemented in the present healthcare environment.

The purpose of this study is to estimate the efficacy of Contralataterally Controlled Functional Electrical Stimulation (CCFES) in reducing upper extremity impairment and activity limitation in chronic upper extremity hemiplegia. CCFES is a rehabilitation intervention in which neuromuscular electrical stimulation (NMES) is applied to the finger and thumb extensor muscles of the paretic upper limb to open the hand. The stroke survivor controls the stimulation intensity, and consequent degree of hand opening, by modulating the degree of opening of the contralateral unimpaired hand, which is detected by an instrumented glove. Thus, volitional opening of the unaffected hand produces stimulated opening of the affected hand. The stimulation paradigm is used to assist the stroke survivor in practicing functional tasks with their affected hand. We will conduct a randomized controlled trial in which chronic stroke survivors (\>6 months post-stroke) will be randomly assigned to receive 12 weeks of CCFES or cyclic NMES, an intervention that provides electrical stimulation of the hand extensors, but with preprogrammed timing and intensity. Randomization will be stratified on two levels of baseline hand impairment defined by the degree of voluntary finger extension present. Assessments of upper extremity impairment and activity limitation will be made every 3 weeks during the treatment period and every 2 months during a 6-month follow-up period.

This study is the first randomized controlled trial of CCFES in chronic upper extremity hemiplegia. Ultimately, the information learned in this study will serve to accelerate the development of treatments for reducing post-stroke disability.

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

Primary outcomes:
measure: Change in Box and Block Test Score at 6 Mo Post-Treatment
timeFrame: 2 timepoints: Prior to treatment, and 6 months after completion of treatment.
Secondary outcomes:
measure: Change in Arm Motor Abilities Test Score at 6-Month Post-Treatment
timeFrame: 2 timepoints: Prior to treatment, and 6 months after completion of treatment.
measure: Change in Upper Extremity Fugl-Meyer Score at 6-Months Post-Treatment
timeFrame: 2 timepoints: Prior to treatment, and 6 months after completion of treatment.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Jayme S. Knutson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Knutson JS, Harley MY, Hisel TZ, Chae J. Improving hand function in stroke survivors: a pilot study of contralaterally controlled functional electric stimulation in chronic hemiplegia. Arch Phys Med Rehabil. 2007 Apr;88(4):513-20. doi: 10.1016/j.apmr.2007.01.003.
citation: Glanz M, Klawansky S, Stason W, Berkey C, Chalmers TC. Functional electrostimulation in poststroke rehabilitation: a meta-analysis of the randomized controlled trials. Arch Phys Med Rehabil. 1996 Jun;77(6):549-53. doi: 10.1016/s0003-9993(96)90293-2.
citation: Chae J, Bethoux F, Bohine T, Dobos L, Davis T, Friedl A. Neuromuscular stimulation for upper extremity motor and functional recovery in acute hemiplegia. Stroke. 1998 May;29(5):975-9. doi: 10.1161/01.str.29.5.975.
citation: Luft AR, McCombe-Waller S, Whitall J, Forrester LW, Macko R, Sorkin JD, Schulz JB, Goldberg AP, Hanley DF. Repetitive bilateral arm training and motor cortex activation in chronic stroke: a randomized controlled trial. JAMA. 2004 Oct 20;292(15):1853-61. doi: 10.1001/jama.292.15.1853.
citation: Whitall J, McCombe Waller S, Silver KH, Macko RF. Repetitive bilateral arm training with rhythmic auditory cueing improves motor function in chronic hemiparetic stroke. Stroke. 2000 Oct;31(10):2390-5. doi: 10.1161/01.str.31.10.2390.
citation: Mudie MH, Matyas TA. Can simultaneous bilateral movement involve the undamaged hemisphere in reconstruction of neural networks damaged by stroke? Disabil Rehabil. 2000 Jan 10-20;22(1-2):23-37. doi: 10.1080/096382800297097.
citation: Knutson JS, Gunzler DD, Wilson RD, Chae J. Contralaterally Controlled Functional Electrical Stimulation Improves Hand Dexterity in Chronic Hemiparesis: A Randomized Trial. Stroke. 2016 Oct;47(10):2596-602. doi: 10.1161/STROKEAHA.116.013791. Epub 2016 Sep 8.