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

Primary Purpose

Ischemic Cerebrovascular Accident

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Task-Oriented Lower Extremity Strengthening Training
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Cerebrovascular Accident focused on measuring task-oriented training, long-term effects, plasticity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Pei-Fang Tang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Stroke

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

10-meter walk test

Secondary Outcome Measures

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

Full Information

First Posted
August 8, 2013
Last Updated
August 29, 2013
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01934374
Brief Title
Long-Term Effects of Task-Oriented Lower Extremity Strengthening Training
Official Title
Long-Term Effects of Task-Oriented Lower Extremity Strengthening Training on Functional Connectivity of the Brain, Motor Functions, Physical Activity Level, and Quality of Life in Patients With Subacute Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: To investigate the long-term effects of a four-week task-oriented lower extremity strengthening training (TOLEST) program in patients with subacute stroke; 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 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.
Detailed Description
We conducted a meta-analysis to examine the effects of task-oriented approach in patients with sub-acute stroke and a preliminary study of an assessor-blind randomized controlled trial with a total of 3 patients with sub-acute stroke (experimental group: E1; control group: C1 and C2). The participants were randomly assigned to the experimental group or the control group. All participants received 4 weeks of exercise training, which were 4 sessions per week and 60 minutes for each session. The experimental group received task-oriented circuit training to improve lower extremity motor functions. The control group received stretch exercises and upper extremity activities in sitting posture. Both groups received clinical asessments on lower extremity motor functions (primary outcomes), the structural integrity of the CST using diffusion spectrum imaging, and the cortical activation patterns of the SMC using functional magnetic resonance imaging(secondary outcomes) at baseline, post-training (week 4), and 1 month follow-up (week 8). Because of the small number of subjects, we also included one subject (E2) who received the same training programs as experimental group in our pilot study as one subject of the training group result. Training effects were descriptively analyzed for individual subjects. The meta-analysis results showed that task-oriented training led to significantly greater improvement than other training on 6-minute walking distance (mean difference = 82.49 meter; 95% confidence interval: 27.59-137.38) and comfortable gait speed (standardized mean difference = 0.27; 95% confidence interval: 0.03-0.52) in patients with subacute stroke. Our preliminary results showed that the experimental group achieved meaningful improvements in most of the primary outcomes but not for the control group. In addition, different brain reorganization patterns were observed in the two groups. The results of meta-analysis provide relevant clinical evidence for the effects of task-oriented training on lower extremity motor functions, and this preliminary study provides the pilot result for the effects of task-oriented circuit training on lower extremity motor functions, brain structural and functional plasticity in patients with sub-acute stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Cerebrovascular Accident
Keywords
task-oriented training, long-term effects, plasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stroke
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Task-Oriented Lower Extremity Strengthening Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
10-meter walk test
Time Frame
up to 4 weeks, change from baseline to 4 weeks
Secondary Outcome Measure Information:
Title
Functional MRI (fMRI), diffusion spectrum imaging (DSI)
Time Frame
up to 4 weeks, change from baseline to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Fang Tang
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pei-Fang Tang
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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

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