Strength Training and Stroke

NCT00629005 | Completed Phase 1

• 1 other identifier: B5033-W
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke

Keywords

rehabilitation; upper extremity; motor skills

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Motor Assessment - UE Subscale

  Immediately after the end of therapy and 6 months later

Secondary Outcomes (2)

• 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

Study Arms (2)

Arm 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

Arm 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

Interventions

Constraint-Induced Movement Therapy + strength training 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

Also known as: forced use, functional task practice, progressive resistive exercise

Arm 1

Constraint-Induced Movement Therapy + range of motion 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

Also known as: forced use, functional task practice

Arm 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 40-85;
• a single unilateral middle cerebral artery ischemic stroke;
• no history of drug/alcohol abuse;
• ability to follow 3-step commands and provide informed consent;
• no history of other neural disorder/dysfunction (including epilepsy), no serious medical illness or refractory depression;
• at least 300 active upper extremity elevation in scapular plane (combination of flexion and abduction);
• ability to extend the wrist 20 degrees, and two fingers and thumb 10 degrees three times in a minute;
• permission of physician (BRRC medical director or BRRC neurologist) to participate in strength training.

You may not qualify if:

• spasticity in elbow or hand (Modified Ashworth Scale \> 2);
• Motor Activity Log32 scores \>3 (which would indicate relatively good use of the upper extremity);
• 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);
• ataxia, major sensory deficits, or hemi-inattention/neglect;

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Constraint Induced Movement Therapy; Resistance Training; Range of Motion, Articular

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Stephen E. Nadeau, MD BS BS

  North Florida/South Georgia Veterans Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: March 5, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 29, 2013

Record last verified: 2013-01

Locations

US (1)