Electrical Stimulation for Recovery of Hand Function in Chronic Stroke Survivors

Stroke Clinical Trial

Official title:

Contralaterally Controlled FES for Chronic Arm/Hand Hemiplegia: Single-Site RCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00891319
• Other study ID #: R01HD059814
• Secondary ID: R01HD059814
• Status: Completed
• Phase: N/A
• First received: September 25, 2008
• Last updated: October 3, 2017
• Start date: January 2009
• Est. completion date: May 2015

Study information

• Verified date: October 2017
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiparesis
• Hemiplegia
• Paresis
• Stroke

Intervention

Device:
• Electrical stimulator
• 12-week intervention Therapist-guided task practice performed twice a week in the research laboratory. (Device used for CCFES group but not for cNMES group during these sessions.) Self-administered CCFES or cNMES-mediated hand opening exercise performed 10 sessions per week at home.

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
MetroHealth Medical Center	Case Western Reserve University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. Erratum in: JAMA. 2004 Nov 24;292(20):2470. — View 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. — View 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. Erratum in: Stroke. 2007 May;38(5):e22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Box and Block Test Score at 6 Mo Post-Treatment	The Box and Blocks test counts how many times the participant can pick up 1 block at t time, move it over a partition, and release it in a target area within 60 seconds.; The minimum score is 0. There is no maximum score. The average score of healthy individuals within the age range of this study ranges from 70 to 79.; Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at 6 months after completion of treatment. Then for each treatment group, these change scores were averaged.	2 timepoints: Prior to treatment, and 6 months after completion of treatment.
Secondary	Change in Arm Motor Abilities Test Score at 6-Month Post-Treatment	The Arm Motor Abilities Test assesses the participant's ability to execute specific upper limb tasks and does not allow for compensation with the unimpaired side. The test consists of 9 compound tasks composed of 1 to 3 component tasks, each of which is rated on a 0 - 5 ordinal scale: 0, no attempt to use affected limb; 1, attempt to use affected limb but it does not participate functionally; 2, affected limb is used only as a helper or stabilizer; 3, affected limb is used slowly or within synergy patterns; 4, almost normal use of affected limb; 5, normal use. The final score is the average of all component task scores across all 9 compound tasks.; The minimum score is 0; maximum score is 5. Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at 6 months after completion of treatment. Then for each treatment group, these change scores were averaged.	2 timepoints: Prior to treatment, and 6 months after completion of treatment.
Secondary	Change in Upper Extremity Fugl-Meyer Score at 6-Months Post-Treatment	The Upper Extremity Fugl-Meyer (UEFM) Assessment is a measure of upper limb motor impairment. Participants are asked to attempt to perform a list of very specific movements of the arm, elbow, forearm, wrist, and hand that take into account synergy patterns, isolated strength, coordination, and hypertonia. Each movement attempt is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and these subscores are summed to provide a maximum score of 66, minimum score of 0.; Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at 6 months after completion of treatment. Then for each treatment group, these change scores were averaged.	2 timepoints: Prior to treatment, and 6 months after completion of treatment.

External Links

•   Cleveland FES Center
•   The MetroHealth System - Clinical Trials