Strength Training and Stroke

Stroke Clinical Trial

Official title:

Should We Train Strength or Skill in Post-Stroke Rehabilitation?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629005
• Other study ID #: B5033-W
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 19, 2008
• Last updated: January 28, 2013
• Start date: February 2008
• Est. completion date: September 2011

Study information

• Verified date: January 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

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• 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
• 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

Locations

Country	Name	City	State
United States	North Florida/South Georgia Veterans Health System	Gainesville	Florida

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 Motor Assessment - UE Subscale		Immediately after the end of therapy and 6 months later	No
Secondary	Wolf Motor Function Test		Immediately after the end of therapy and 6 months later	No
Secondary	Cortical mapping using transcranial magnetic stimulation		Immediately after the end of therapy	No