Strength Training and Stroke

NCT ID: NCT00629005

Last Updated: 2013-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2011-09-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1

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

Group Type: EXPERIMENTAL

Constraint-Induced Movement Therapy + strength training

Intervention Type: BEHAVIORAL

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

Arm 2

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

Group Type: ACTIVE_COMPARATOR

Constraint-Induced Movement Therapy + range of motion

Intervention Type: BEHAVIORAL

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

Interventions

Constraint-Induced Movement Therapy + strength training

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

Constraint-Induced Movement Therapy + range of motion

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

Intervention Type: BEHAVIORAL

Other Intervention Names

forced use, functional task practice, progressive resistive exercise; forced use, functional task practice

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen E. Nadeau, MD BS BS

Role: PRINCIPAL_INVESTIGATOR

North Florida/South Georgia Veterans Health System

Locations

North Florida/South Georgia Veterans Health System

Gainesville, Florida, United States

Countries

United States

Other Identifiers

B5033-W

Identifier Type: -

Identifier Source: org_study_id