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Strength Training and Stroke
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, July 2008
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00629005
  Purpose

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


Condition Intervention Phase
Stroke
Behavioral: Constraint-Induced Movement Therapy + strength training
Behavioral: Constraint-Induced Movement Therapy + range of motion
Phase I
Phase II

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: Should We Train Strength or Skill in Post-Stroke Rehabilitation?

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Fugl-Meyer Motor Assessment - UE Subscale [ Time Frame: Immediately after the end of therapy and 6 months later ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Wolf Motor Function Test [ Time Frame: Immediately after the end of therapy and 6 months later ] [ Designated as safety issue: No ]
  • Cortical mapping using transcranial magnetic stimulation [ Time Frame: Immediately after the end of therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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
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
2: Active Comparator
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age 40-85;
  2. mild-moderate hemiparesis, as defined by a score of > 30 on the Fugl Meyer Motor Assessment, upper extremity subscale (UE_FM)21, from a single unilateral middle cerebral artery ischemic stroke 1-5 years previously;
  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 200, and two fingers and thumb 100 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 1350 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;
  5. contraindications to MRI or TMS including:

    1. having certain kinds of metal, including a metallic implant or clip in the head/neck, metal implanted in the scalp area to which TMS will be applied, an implanted prosthetic heart valve, implanted medication pumps and lines, cardiac pacemaker, neuron-stimulation device, and orthodontic work involving ferromagnetic materials;
    2. having a tattoo consisting of permanent black eye-liner;
    3. pregnancy (the safety of magnetic resonance examination for embryos and fetuses, while likely very good based on available data, has not been completely established);
    4. engagement in occupations or activities that may cause accidental lodging of ferromagnetic materials or potential presence of embedded metal fragments from military activities, unless cleared by a head CT scan;
    5. severe and uncontrolled migraine headaches;
    6. taking of medications that lower seizure threshold, such as tricyclic antidepressants and neuroleptics;
    7. claustrophobia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629005

Contacts
Contact: Sandra B Davis, BS (352) 376-1611 ext 5227 Sandra.Davis2@med.va.gov

Locations
United States, Florida
North Florida/South Georgia Veterans Health System Recruiting
Gainesville, Florida, United States, 32608
Contact: Lorie G Richards, PhD         lrichard@phhp.ufl.edu    
Principal Investigator: Lorie G Richards, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: Lorie G Richards, PhD North Florida/South Georgia Veterans Health System
  More Information

Publications of Results:
Responsible Party: Department of Veterans Affairs ( Richards, Lorie - Principal Investigator )
Study ID Numbers: B5033W
Study First Received: February 19, 2008
Last Updated: July 29, 2008
ClinicalTrials.gov Identifier: NCT00629005  
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
rehabilitation
upper extremity
motor skills

Study placed in the following topic categories:
Cerebral Infarction
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases
Ischemia
Brain Infarction
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009