Treatment of Hand Dysfunction After Stroke

NCT00508521 | Completed Results

• 1 other identifier: B4078-R
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Many stroke survivors exhibit persistent upper limb motor deficits and a non-functional upper limb. There is some promising information that suggests motor learning (ML) in conjunction with functional electrical stimulation (FES; surface FES; nothing implanted; use of a commercially available system) of wrist/finger muscles can significantly enhance the functional level of the upper limb. There have been promising studies showing that some subjects in the chronic phase (greater than 6 months after stroke) responded favorably to combination FES and ML (FES ML). In our pilot studies, FES ML for those in the chronic phase (\>12 months) produced statistically significant functional recovery. FES was applied using a commercially available, two-channel FES system, with electrodes applied to the surface of the skin (non-invasive). But if upper limb dysfunction is not immediately treated, that is within the sub-acute phase (less than 6 months) following stroke, the following problems can develop: contractures and other soft tissue changes; chronic pain; and ingrained, abnormal, non-functional movement patterns. The more long-standing these symptoms are, the more resistant to treatment they become. Therefore, it is important to provide promising interventions prior to the onset of chronic symptoms and dysfunction. Those in the sub-acute phase after stroke should be provided with FES ML, in order to more completely restore function for a greater number of stroke survivors. Specific Aims and Hypotheses The goal of this pilot study is to test the feasibility of the proposed treatment in the sub acute phase following stroke. HYPOTHESIS. FES ML for 3hrs/day, five days/week, for 12 weeks will be feasible to implement in the sub-acute phase following stroke (2 -24 weeks). Study Design a. Specific Procedures This is a pilot study to test the feasibility of using FES ML for upper extremity rehabilitation in a sub-acute stroke population. It is a randomized, controlled, single-blind design. Subjects will be 2 - 24 weeks after a single stroke. The control group will receive standard care for upper limb rehabilitation consisting of passive and active exercise, stretching, bracing, and use of adaptive devices. The experimental group will receive the experimental intervention in addition to their standard care. CONTROL GROUP INTERVENTION. The control group will receive the standard medical care prescribed by the primary physician and covered by the subject's health care policy. Standard care will include: soft tissue mobilization; assisted motion exercise; active motion exercise; resistive exercise; task practice; use of assistive devices; and modality applications conventionally prescribed. FES ML INTERVENTION. The research treatment duration will be 3hrs/day, five days per week. The subjects will be present for a fourth hour each day, which will be used for breaks and rest periods that will be interspersed throughout the intervention time. The treatment duration is derived from prior work. We will stimulate muscles in a number of configurations including: wrist extension and finger extension; wrist extension and finger flexion; and wrist extension, finger flexion, and thumb abduction and opposition. Motor learning will include the performance of functional task components and full task practice during the use of FES. FES will be triggered by the patient, the treating therapist, or it will be automatically sequenced by the device according to alternate channel activations, with timings pre-set by the treating therapist. MEASURES. Data will be collected at weeks 1, 6, 12 (end of treatment), and 6 months after the end of treatment. Population The subjects will be sub-acute stroke survivors (2-24 weeks after stroke).

Conditions

Stroke

Keywords

cerebrovascular accident; electrical stimulation; motor learning; upper extremity rehabilitation

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Upper Limb Coordination Scale (FMUE)

  A subscale of the Fugl-Meyer; the Fugl-Meyer Upper Limb Coordination Scale is a measure of movement coordination in and out of synergy patterns for the hemiparetic upper limb; scores range from 0-66, with 0 being the worst score and 66 being the best score.

  baseline and after 12 weeks of training

Study Arms (2)

FES and Motor Learning Training

EXPERIMENTAL

participants \<6 months after first stroke who presented with arm dysfunction were trained using FES and Motor Learning

Device: Functional Electrical Stimulation

Control group

OTHER

Subjects in this arm will receive standard care as prescribed by their physician and covered by their insurance

Other: Standard Care

Interventions

Functional Electrical Stimulation DEVICE

commercially available surface electrical stimulator

FES and Motor Learning Training

Standard Care OTHER

Standard care as ordered by their physician and covered by their insurance company.

Control group

Eligibility Criteria

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

You may qualify if:

• weeks after stroke
• Greater than 21 years old
• Ability to follow 2 step commands

You may not qualify if:

• Chronic, progressive medical condition (i.e. Parkinson's Disease)

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Cleveland

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

This was a small pilot feasibility study providing data for future work.

Results Point of Contact

• Title: Janis Daly, Ph.D., M.S.; Director, Brain Rehabilitation Research Center
• Organization: Malcom Randall VA Medical Center, Gainesville Florida

janis.daly@neurology.ufl.edu

(352) 376-1611

Study Officials

• Janis Daly, PhD MS

  VA Medical Center-Cleveland

  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: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2007
• First Posted: July 30, 2007
• Study Start: January 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 7, 2014
• Results First Posted: February 7, 2014

Record last verified: 2013-12

Locations

US (1)