Long-Term Effects of Task-Oriented Lower Extremity Strengthening Training

NCT01934374 | Completed DMC

• 1 other identifier: 200812148R
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Task-oriented exercises combined with strengthening have been shown effective in improving walking functions in patients with chronic stroke. However, similar approaches of therapeutic exercises have not been applied to subacute stroke with long-term follow-up, using outcome measures across the three levels of functioning (body functions/structure, activities, and participation) of the International Classification of Functioning, Disability, and Health (ICF) model. Therefore, this study will be conducted to fulfill three purposes:

1. 1.To investigate the long-term effects of a four-week task-oriented lower extremity strengthening training (TOLEST) program in patients with subacute stroke;
2. 2.To investigate the interrelationships among functional connectivity of the brain, lower extremity motor functions, physical activity level, and quality of life in patients with stroke who have received this four-week TOLEST program in the subacute phase of stroke; and
3. 3.To identify prognostic factors for recovery in functional connectivity of the brain, lower extremity motor functions, physical activity level, and quality of life in patients with stroke who have received this four-week TOLEST program in the subacute phase of stroke.

Conditions

Ischemic Cerebrovascular Accident

Keywords

task-oriented training, long-term effects, plasticity

Outcome Measures

Primary Outcomes (1)

• 10-meter walk test

  up to 4 weeks, change from baseline to 4 weeks

Secondary Outcomes (1)

• Functional MRI (fMRI), diffusion spectrum imaging (DSI)

  up to 4 weeks, change from baseline to 4 weeks

Study Arms (2)

Stroke

EXPERIMENTAL

On the 30th day post stroke (D30), the exjperimental group will start to receive the task-oriented lower extremity strengthening training (TOLEST) program for four weeks, one hour per session and three sessions per week. The TOLEST focuses on using task-specific circuit training combined with strengthening of bilateral lower limbs.

Behavioral: Task-Oriented Lower Extremity Strengthening Training

Control

NO INTERVENTION

The control group will receive equal-dose exercises starting on D30, with the emphasis on stretching and non-functional movements of the affected lower extremity.

Interventions

Task-Oriented Lower Extremity Strengthening Training BEHAVIORAL

On the 30th day post stroke (D30), the experimental group will start to receive the TOLEST program for four weeks, one hour per session and three sessions per week. The TOLEST focuses on using task-specific circuit training combined with strengthening of bilateral lower limbs. The control group will receive equal-dose exercises starting on D30, with the emphasis on stretching and non-functional movements of the affected lower extremity.

Stroke

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• in the subacute stage of stroke (within 20 to 30 days post-onset) and stable medical condition;
• presence of residual gait impairment;
• being able to walk 5 m with or without assistive device independently;
• the paretic lower leg being able to perform at least 10 degrees of active ankle dorsiflexion from the resting position;
• no apparent spasticity in affected leg to interfere the affected limb movement (Modified Ashworth Scale \< 2)

You may not qualify if:

• claustrophobia and indwelling metals or implanted devices incompatible with fMRI testing;
• serious cardiac conditions (e.g. unstable angina serious cardiac arrhythmias, heart failure, hypertrophic cardiomyopathy, severe aortic stenosis, pulmonary embolus, or infarction);
• symptoms or history of other neurological or orthopedic problems which would affect their lower limb function;
• severe cognitive, perceptual, or communication problems

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Pei-Fang Tang

Taipei, Taiwan, 100, Taiwan

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Pei-Fang Tang

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: September 4, 2013
• Study Start: March 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 4, 2013

Record last verified: 2013-08

Locations

TW (1)