Functional Electrical Stimulation (FES) for Upper Extremity Recovery in Stroke

NCT00142792 | Completed Results

• 1 other identifier: R01HD049777
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 3

Brief Summary

Stroke is the leading cause of activity limitation among older adults in the United States. NeuroMuscular Electrical Stimulation (NMES) can assist stroke survivors in regaining motor ability and decreasing activity limitation caused by stroke. This study will research the effects of two types of NMES on reducing motor impairment and activity limitation.

Conditions

Stroke, Acute; Stroke; Hemiparesis

Keywords

stroke; recovery of function; functional electrical stimulation (FES)

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure

  The FMA battery measures six dimensions of post-stroke impairment including upper and lower limb motor impairment, range of motion, pain, reflexes, and sensation. , "Each item (33 total) is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and summed to provide a score ranging from 0 to 66, where higher scores indicate better motor function The FMA was administered with the participant seated.

  FMA will be administered on 6 occasions: at baseline, mid-treatment, end of treatment, and follow-up at 1-,3- and 6-months post-treatment.

Secondary Outcomes (1)

• Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation

  AMAT will be administered on 6 occasions as above: at baseline, mid-treatment, end of treatment, and follow-up at 1-,3- and 6-months post-treatment.

Study Arms (3)

A. Cyclic stim

ACTIVE COMPARATOR

* Preprogrammed cycles of finger and thumb flexor and extensor stimulation (and flexor stimulation if deemed necessary by the PI) repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject. * Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation * Uses NMES device with EMG-triggered and Cyclic capabilities

Device: NMES device with EMG-triggered and Cyclic capabilities

B. Sensory stim

ACTIVE COMPARATOR

Sensory-only electrical stimulation. The stimulation will be cyclic in nature but intensity will be set to a level that can be felt by the patient but not sufficient to cause muscle contraction. Uses NMES device with EMG-triggered and Cyclic capabilities

Device: NMES device with EMG-triggered and Cyclic capabilities

C. EMG-Triggered

ACTIVE COMPARATOR

EMG-Triggered electrical stimulation. Subjects in this group will attempt to extend their affected wrist and fingers in response to an audio cue. They will be "rewarded" with stimulation to cause full hand opening once they have generated EMG sufficient to reach a preset threshold level. Uses NMES device with EMG-triggered and Cyclic capabilities

Device: NMES device with EMG-triggered and Cyclic capabilities

Interventions

NMES device with EMG-triggered and Cyclic capabilities DEVICE

All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.

Also known as: NeuroMove NM900 stimulator

A. Cyclic stim; B. Sensory stim; C. EMG-Triggered

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-89
• Evidence of clinical symptoms from a hemorrhagic or nonhemorrhagic stroke with all symptoms from previous stroke(s) completely resolved
• Medically stable
• Less than 6 months post-stroke
• Intact skin on the hemiparetic side
• Able to follow 3-stage commands
• Able to recall 2/3 objects after 30 minutes
• Full passive ROM at the wrist and the thumb, index and long finger MCP joints on the affected side
• Presence of a detectable, volitionally-activated EMG signal from the paretic wrist or finger extensors (ECR or EDC)
• Affected wrist extensors ≤ 4 on MRC scale
• Score of ≤ 11/14 on Section C (hand) of UE portion of Fugl Meyer Assessment (FMA)
• Ability to tolerate NMES to the ECR and EDC for full wrist and finger extension
• Caregiver available to assist with the device every day (unless subject capable of using it independently

You may not qualify if:

• History of ventricular arrythmias or any other arrythmias (i.e. fast atrial fibrillation, ventricular tachycardia, or supraventricular tachycardia) with hemodynamic instability
• History of other upper motor neuron lesion
• Absent sensation of the affected limb
• Pregnancy
• History of more than one seizure per month during the last year (or, since the stroke if no seizures prior to stroke)
• Discharge to a skilled nursing facility or long-term care facility (EXCEPTION: Subjects may be d/c'd to the 6A SNF unit at MetroHealth Medical Center)
• Uncompensated hemineglect
• Implanted stimulator (such as a pacemaker)
• Evidence of hand pain as defined by current metacarpophalangeal (MCP) joint pain upon palpation and/or wrist or MCP pain upon extension

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 (3)

Edwin Shaw Rehab - Akron General Medical Center

Akron, Ohio, 44312, United States

Location

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45267, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (12)

• 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

• Powell J, Pandyan AD, Granat M, Cameron M, Stott DJ. Electrical stimulation of wrist extensors in poststroke hemiplegia. Stroke. 1999 Jul;30(7):1384-9. doi: 10.1161/01.str.30.7.1384.

  PMID: 10390311 BACKGROUND

• Francisco G, Chae J, Chawla H, Kirshblum S, Zorowitz R, Lewis G, Pang S. Electromyogram-triggered neuromuscular stimulation for improving the arm function of acute stroke survivors: a randomized pilot study. Arch Phys Med Rehabil. 1998 May;79(5):570-5. doi: 10.1016/s0003-9993(98)90074-0.

  PMID: 9596400 BACKGROUND

• Cauraugh J, Light K, Kim S, Thigpen M, Behrman A. Chronic motor dysfunction after stroke: recovering wrist and finger extension by electromyography-triggered neuromuscular stimulation. Stroke. 2000 Jun;31(6):1360-4. doi: 10.1161/01.str.31.6.1360.

  PMID: 10835457 BACKGROUND

• Cauraugh JH, Kim S. Two coupled motor recovery protocols are better than one: electromyogram-triggered neuromuscular stimulation and bilateral movements. Stroke. 2002 Jun;33(6):1589-94. doi: 10.1161/01.str.0000016926.77114.a6.

  PMID: 12052996 BACKGROUND

• Sonde L, Gip C, Fernaeus SE, Nilsson CG, Viitanen M. Stimulation with low frequency (1.7 Hz) transcutaneous electric nerve stimulation (low-tens) increases motor function of the post-stroke paretic arm. Scand J Rehabil Med. 1998 Jun;30(2):95-9. doi: 10.1080/003655098444192.

  PMID: 9606771 BACKGROUND

• Sonde L, Kalimo H, Fernaeus SE, Viitanen M. Low TENS treatment on post-stroke paretic arm: a three-year follow-up. Clin Rehabil. 2000 Feb;14(1):14-9. doi: 10.1191/026921500673534278.

  PMID: 10688340 BACKGROUND

• Bowman BR, Baker LL, Waters RL. Positional feedback and electrical stimulation: an automated treatment for the hemiplegic wrist. Arch Phys Med Rehabil. 1979 Nov;60(11):497-502.

  PMID: 508075 BACKGROUND

• Kraft GH, Fitts SS, Hammond MC. Techniques to improve function of the arm and hand in chronic hemiplegia. Arch Phys Med Rehabil. 1992 Mar;73(3):220-7.

  PMID: 1543423 BACKGROUND

• Kimberley TJ, Lewis SM, Auerbach EJ, Dorsey LL, Lojovich JM, Carey JR. Electrical stimulation driving functional improvements and cortical changes in subjects with stroke. Exp Brain Res. 2004 Feb;154(4):450-60. doi: 10.1007/s00221-003-1695-y. Epub 2003 Nov 15.

  PMID: 14618287 BACKGROUND

• Wilson RD, Page SJ, Delahanty M, Knutson JS, Gunzler DD, Sheffler LR, Chae J. Upper-Limb Recovery After Stroke: A Randomized Controlled Trial Comparing EMG-Triggered, Cyclic, and Sensory Electrical Stimulation. Neurorehabil Neural Repair. 2016 Nov;30(10):978-987. doi: 10.1177/1545968316650278. Epub 2016 May 24.

  PMID: 27225977 DERIVED

Related Links

• Cleveland FES Center
• The MetroHealth System - Clinical Trials
• Neuromotor Recovery \& Rehabilitation Laboratory, Cincinnati, Ohio

MeSH Terms

Conditions

Stroke; Paresis

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

Limitations and Caveats

the estimated sample size needed to reach 90% power to detect clinically meaningful differences within the groups was not met due to slow recruitment. The lower power creates the possibility that a type II error was made.

Results Point of Contact

• Title: Richard WIlson, MD
• Organization: MetroHealth Medical Center

rwilson@metrohealth.org

216-957-3559

Study Officials

• John Chae, MD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Prof Vice Chair Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 2, 2005
• Study Start: December 1, 2005
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 29, 2018
• Results First Posted: March 29, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)