Clinical trial NCT00629005: Strength Training and Stroke
Official title: Should We Train Strength or Skill in Post-Stroke Rehabilitation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stroke
Keywords: rehabilitation
upper extremity
motor skills
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-03-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Fugl-Meyer Motor Assessment - UE Subscale
timeFrame: Immediately after the end of therapy and 6 months later
Secondary outcomes:
measure: Wolf Motor Function Test
timeFrame: Immediately after the end of therapy and 6 months later
measure: Cortical mapping using transcranial magnetic stimulation
timeFrame: Immediately after the end of therapy
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System
state: Florida
Study officials:
affiliation: North Florida/South Georgia Veterans Health System
name: Stephen E. Nadeau, MD BS BS
role: PRINCIPAL_INVESTIGATOR
References: