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Strength Training and Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Constraint-Induced Movement Therapy + strength training
Constraint-Induced Movement Therapy + range of motion
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 rehabilitation, upper extremity, motor skills

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. age 40-85;
  2. a single unilateral middle cerebral artery ischemic stroke;
  3. no history of drug/alcohol abuse;
  4. ability to follow 3-step commands and provide informed consent;
  5. no history of other neural disorder/dysfunction (including epilepsy), no serious medical illness or refractory depression;
  6. at least 300 active upper extremity elevation in scapular plane (combination of flexion and abduction);
  7. ability to extend the wrist 20 degrees, and two fingers and thumb 10 degrees three times in a minute;
  8. permission of physician (BRRC medical director or BRRC neurologist) to participate in strength training.

Exclusion Criteria:

  1. spasticity in elbow or hand (Modified Ashworth Scale > 2);
  2. Motor Activity Log32 scores >3 (which would indicate relatively good use of the upper extremity);
  3. ability to complete 135 degrees shoulder elevation easily with elbow straight (e.g., doesn't hold breath, movement is fluid, little to no effort tremor observed);
  4. ataxia, major sensory deficits, or hemi-inattention/neglect;

Sites / Locations

  • North Florida/South Georgia Veterans Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Constraint-Induced Movement Therapy (wear a mitt on non-paretic hand for 90% of waking hours + functional task practice for 3 hours) plus 1 hour of strength training for the arms and hands 3x/week

Constraint-Induced Movement Therapy (wear a mitt on non-paretic hand for 90% of waking hours + functional task practice for 3 hours) plus non-resisted arm and hand movements for 1 hour 3x/week

Outcomes

Primary Outcome Measures

Fugl-Meyer Motor Assessment - UE Subscale

Secondary Outcome Measures

Wolf Motor Function Test
Cortical mapping using transcranial magnetic stimulation

Full Information

First Posted
February 19, 2008
Last Updated
January 28, 2013
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00629005
Brief Title
Strength Training and Stroke
Official Title
Should We Train Strength or Skill in Post-Stroke Rehabilitation?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
September 2011 (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
People with stroke experience weakness and incoordination. Studies have shown that with functional task practice, people can increase motor control and strength to a certain extent. This study will investigate whether adding progressive resistance strength training to functional task practice modeled after Constraint-Induced Movement Therapy results in greater motor function gains than functional task practice alone
Detailed Description
To date most investigations of UE rehabilitation have examined single interventions. However, combining 2 efficacious interventions may enhance effectiveness. Both functional task training and strength training are beneficial for promoting improved upper extremity function, but they have seldom been studied as a coupled therapy. The research proposed in this project will examine the effect on UE function of adding UE resistive exercises to functional task training. Secondary aims are to examine the effect of stroke severity on the response to therapy, the interrelationship between therapy-induced neural changes and movement composition and functional changes with therapy, and test for retention of UE function gains over 6 months. Individuals with chronic hemiparesis from stroke will complete baseline testing and then be randomly assigned to either the functional task + strength training group or the functional task training alone group. Each group will train 4 hours/day, 3 days/week for 4 weeks. Each will perform 3 hours of functional task training per session. The strengthening group will then complete 1 hour of UE progressive resistance exercises while the functional task training alone group will complete gravity eliminated range of motion exercises for 1 hour. All subjects will be post-tested and then complete follow-up testing 6 months later.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
rehabilitation, upper extremity, motor skills

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Constraint-Induced Movement Therapy (wear a mitt on non-paretic hand for 90% of waking hours + functional task practice for 3 hours) plus 1 hour of strength training for the arms and hands 3x/week
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Constraint-Induced Movement Therapy (wear a mitt on non-paretic hand for 90% of waking hours + functional task practice for 3 hours) plus non-resisted arm and hand movements for 1 hour 3x/week
Intervention Type
Behavioral
Intervention Name(s)
Constraint-Induced Movement Therapy + strength training
Other Intervention Name(s)
forced use, functional task practice, progressive resistive exercise
Intervention Description
Participants wears a mitt on non-paretic hand for 90% of waking hours and completes 3 hours of functional task practice (e.g., flipping cards, putting coins in coin slot, putting cans on a shelf) plus 1 hour of resistance elastic band exercises
Intervention Type
Behavioral
Intervention Name(s)
Constraint-Induced Movement Therapy + range of motion
Other Intervention Name(s)
forced use, functional task practice
Intervention Description
Participants wears a mitt on non-paretic hand for 90% of waking hours and completes 3 hours of functional task practice (e.g., flipping cards, putting coins in coin slot, putting cans on a shelf) plus 1 hour of unresisted arm movements for
Primary Outcome Measure Information:
Title
Fugl-Meyer Motor Assessment - UE Subscale
Time Frame
Immediately after the end of therapy and 6 months later
Secondary Outcome Measure Information:
Title
Wolf Motor Function Test
Time Frame
Immediately after the end of therapy and 6 months later
Title
Cortical mapping using transcranial magnetic stimulation
Time Frame
Immediately after the end of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 40-85; a single unilateral middle cerebral artery ischemic stroke; no history of drug/alcohol abuse; ability to follow 3-step commands and provide informed consent; no history of other neural disorder/dysfunction (including epilepsy), no serious medical illness or refractory depression; at least 300 active upper extremity elevation in scapular plane (combination of flexion and abduction); ability to extend the wrist 20 degrees, and two fingers and thumb 10 degrees three times in a minute; permission of physician (BRRC medical director or BRRC neurologist) to participate in strength training. Exclusion Criteria: spasticity in elbow or hand (Modified Ashworth Scale > 2); Motor Activity Log32 scores >3 (which would indicate relatively good use of the upper extremity); ability to complete 135 degrees shoulder elevation easily with elbow straight (e.g., doesn't hold breath, movement is fluid, little to no effort tremor observed); ataxia, major sensory deficits, or hemi-inattention/neglect;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen E. Nadeau, MD BS BS
Organizational Affiliation
North Florida/South Georgia Veterans Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Florida/South Georgia Veterans Health System
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States

12. IPD Sharing Statement

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Strength Training and Stroke

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