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Completed

NCT Number: NCT00629005

Strength Training and Stroke

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;

Treatment and study plan

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

Other names: forced use, functional task practice, progressive resistive exercise

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

Other names: forced use, functional task practice

Primary outcomes

  1. Fugl-Meyer Motor Assessment - UE Subscale

    Time frame: Immediately after the end of therapy and 6 months later

Secondary outcomes

  1. Wolf Motor Function Test

    Time frame: Immediately after the end of therapy and 6 months later

  2. Cortical mapping using transcranial magnetic stimulation

    Time frame: Immediately after the end of therapy

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Mar 5, 2008
Registry last updated
Jan 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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