Strength Training and Stroke

Phase 1

Completed

• Conditions: Stroke
• Interventions: Behavioral: Constraint-Induced Movement Therapy + strength training; Behavioral: Constraint-Induced Movement Therapy + range of motion

• Registration Number: NCT00629005
• Lead Sponsor: US Department of Veterans Affairs

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-19
• Study First Submitted QC: 2008-02-26
• Study First Posted: 2008-03-05
• Primary Completion: 2011-07
• Study Completion: 2011-09
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-28
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Constraint-Induced Movement Therapy + strength training	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 2	Constraint-Induced Movement Therapy + range of motion	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

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Motor Assessment - UE Subscale	Immediately after the end of therapy and 6 months later

Secondary Outcome Measures

Name	Time	Method
Wolf Motor Function Test	Immediately after the end of therapy and 6 months later
Cortical mapping using transcranial magnetic stimulation	Immediately after the end of therapy

Trial Locations

Locations (1)

North Florida/South Georgia Veterans Health System; 🇺🇸 Gainesville, Florida, United States