Treatment of Hand Dysfunction After Stroke

Stroke Clinical Trial

Official title:

Treatment of Hand Dysfunction After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508521
• Other study ID #: B4078-R
• Status: Completed
• Phase: N/A
• First received: July 27, 2007
• Last updated: December 19, 2013
• Start date: January 2007
• Est. completion date: June 2010

Study information

• Verified date: December 2013
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: June 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 2-24 weeks after stroke

• Greater than 21 years old

• Ability to follow 2 step commands

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Functional Electrical Stimulation
commercially available surface electrical stimulator

Other:
• Standard Care
Standard care as ordered by their physician and covered by their insurance company.

Locations

Country	Name	City	State
United States	VA Medical Center, Cleveland	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No