search
Back to results

Treatment of Hand Dysfunction After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functional Electrical Stimulation
Standard Care
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring cerebrovascular accident, electrical stimulation, motor learning, upper extremity rehabilitation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • VA Medical Center, Cleveland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

FES and Motor Learning Training

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 27, 2007
Last Updated
December 19, 2013
Sponsor
US Department of Veterans Affairs
search

1. Study Identification

Unique Protocol Identification Number
NCT00508521
Brief Title
Treatment of Hand Dysfunction After Stroke
Official Title
Treatment of Hand Dysfunction After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
cerebrovascular accident, electrical stimulation, motor learning, upper extremity rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FES and Motor Learning Training
Arm Type
Experimental
Arm Description
participants <6 months after first stroke who presented with arm dysfunction were trained using FES and Motor Learning
Arm Title
Control group
Arm Type
Other
Arm Description
Subjects in this arm will receive standard care as prescribed by their physician and covered by their insurance
Intervention Type
Device
Intervention Name(s)
Functional Electrical Stimulation
Intervention Description
commercially available surface electrical stimulator
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Standard care as ordered by their physician and covered by their insurance company.
Primary Outcome Measure Information:
Title
Fugl-Meyer Upper Limb Coordination Scale (FMUE)
Description
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.
Time Frame
baseline and after 12 weeks of training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janis Daly, PhD MS
Organizational Affiliation
VA Medical Center, Cleveland
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment of Hand Dysfunction After Stroke

We'll reach out to this number within 24 hrs