Treatments for Recovery of Hand Function in Acute Stroke Survivors

NCT00565045 | Completed Phase 1 Results

• 1 other identifier: R21HD054749
• Study Type: interventional
• Target: 21
• 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 investigate whether two different types of treatment improve recovery of hand function after stroke.

Conditions

Stroke, Acute; Stroke; Hemiparesis; Hemiplegia

Keywords

hand; stroke; hemiplegia; electrical stimulation; recovery

Outcome Measures

Primary Outcomes (1)

• Maximum Voluntary Finger Extension Angle (a Measure of Hand Impairment)

  A custom-built electrogoniometer recorded the angles of the metacarpophalangeal (MP) and proximal interphalangeal (PIP) joints of the index finger simultaneously. Participants were seated with the forearm and wrist supported and stabilized in a neutral posture. From this resting postion, they were instructed to extend their fingers as fully as possible in response to a 4-sec audio cue. The MP and PIP angles were added together, providing a composite measure of degree of finger extension, where 0 degrees corresponds to full extension of the MP and PIP joints. The more negative the angle, the more flexed the finger.

  3 months post-treatment.

Secondary Outcomes (4)

• Finger Tracking Error

  3 months post-treatment.

• Box and Blocks Score

  3 months post-treatment.

• Arm Motor Abilities Test

  3 months post-treatment.

• Fugl-Meyer Assessment (Upper Extremity)

  3 months post-treatment.

Study Arms (2)

CCFES

EXPERIMENTAL

CCFES - Contralaterally Controlled Functional Electrical Stimulation * Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing 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: Neuromuscular electrical stimulator

cNMES

ACTIVE COMPARATOR

cNMES - Cyclic NeuroMuscular Electrical Stimulation. * Preprogrammed cycles of finger and thumb flexor and extensor stimulation 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 * Therapy sessions are done without the stimulation system

Device: Neuromuscular electrical stimulator

Interventions

Neuromuscular electrical stimulator DEVICE

Intervention Characteristics Common to Both Groups • 6-week intervention 1. Home "exercise", daily 1. Exercise (at home) 2 sessions/day 2. A "session" consists of 3 (for CCFES) or 4 (for cNMES) 15-min sets separated by 5 min rest 3. A "set" entails hand opening, closing, and relaxing in response or synchrony to light and sound cues and according to group-specific instructions 2. Lab "therapy", 2x/week 1. Two 1.5-hr sessions/week, working on functional hand tasks and tracking task (if possible).

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 to 80
• Within 6 months of first clinical hemorrhagic or nonhemorrhagic stroke
• Cortical or subcortical stroke
• Unilateral upper extremity hemiparesis with severe finger extensor and flexor paresis (\<= grade 4 on Medical Research Council (MRC) scale)
• Adequate movement of the shoulder and elbow to allow volitional positioning of the affected hand in the workspace.
• Surface NMES of finger and thumb extensors produces functional hand opening without pain
• Full volitional opening of the contralateral hand of the unimpaired side.
• Able to follow 3 stage commands
• Able to remember at least 2 of 3 items after 30 minutes
• Able to hear and respond (by opening the less affected hand) to auditory cues issued from the stimulator?
• Caregiver available and willing to help assist with the device and home regimen and ensure compliance
• Skin intact on hemiparetic arm
• Medically stable

You may not qualify if:

• Insensate forearm and/or hand
• Edema of the affected forearm and/or hand
• History of potentially fatal cardiac arrhythmias.
• Cardiac pacemakers or any other implanted electronic systems
• Pregnant women
• Uncontrolled seizure disorder
• Severely impaired cognition or comprehension
• Uncompensated hemineglect
• Severe depression (\>= 13 on Beck Depression Inventory Fast Screen)
• Ipsilateral lower motor neuron lesion
• Parkinson's Disease
• Spinal cord injury
• Traumatic brain injury
• Multiple sclerosis
• Lack of functional passive range of motion of the wrist or fingers of affected side

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• Case Western Reserve University: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (6)

• 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

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

216-778-8364

Study Officials

• Jayme S Knutson, PhD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: November 27, 2007
• First Posted: November 29, 2007
• Study Start: July 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: December 19, 2018
• Results First Posted: July 10, 2013

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)