Electrical Stimulation for Recovery of Hand Function in Chronic Stroke Survivors

NCT00891319 | Completed Results

• 1 other identifier: R01HD059814
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Hemiparesis; Hemiplegia

Keywords

hand; stroke; hemiplegia; electrical stimulation; recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Arm Motor Abilities Test Score at 6-Month Post-Treatment

  2 timepoints: Prior to treatment, and 6 months after completion of treatment.

• Change in Upper Extremity Fugl-Meyer Score at 6-Months Post-Treatment

  2 timepoints: Prior to treatment, and 6 months after completion of treatment.

Study Arms (2)

CCFES

EXPERIMENTAL

CCFES - Contralaterally Controlled Functional Electrical Stimulation * Electrical stimulator * Stimulation to finger and thumb extensors only in response to, and with an intensity proportional to, opening of the contralateral unimpaired hand. * A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity. * Therapy sessions are done with the subject being assisted by the CCFES system.

Device: Electrical stimulator

cNMES

ACTIVE COMPARATOR

cNMES - Cyclic NeuroMuscular Electrical Stimulation * Electrical stimulator * Preprogrammed cycles of finger and thumb extensor stimulation repeatedly and automatically open the hand. * Subject instructed to not move the contralateral arm/hand during stimulation. * Therapy sessions are done without the stimulation system.

Device: Electrical stimulator

Interventions

Electrical stimulator DEVICE

• 12-week intervention 1. 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.) 2. Self-administered CCFES or cNMES-mediated hand opening exercise performed 10 sessions per week at home.

CCFES; cNMES

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Case Western Reserve University: collaborator

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (7)

• 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.

  PMID: 17398254 BACKGROUND

• 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.

  PMID: 8831470 BACKGROUND

• 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.

  PMID: 9596245 BACKGROUND

• 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.

  PMID: 15494583 BACKGROUND

• 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.

  PMID: 11022069 BACKGROUND

• 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.

  PMID: 10661755 BACKGROUND

• 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.

  PMID: 27608819 DERIVED

Related Links

• Cleveland FES Center
• The MetroHealth System - Clinical Trials

MeSH Terms

Conditions

Stroke; Paresis; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis

Results Point of Contact

• Title: Dr. Jayme Knutson
• Organization: MetroHealth Medical Center

jsk12@case.edu

2169573557

Study Officials

• Jayme S. Knutson, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: September 25, 2008
• First Posted: May 1, 2009
• Study Start: January 1, 2009
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 6, 2017
• Results First Posted: November 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)