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

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

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. To investigate the long-term effects of a four-week task-oriented lower extremity strengthening training (TOLEST) program in patients with subacute stroke;
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. 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.

Study Overview

• Status: Completed
• Conditions: Ischemic Cerebrovascular Accident
• Intervention / Treatment: Behavioral: Task-Oriented Lower Extremity Strengthening Training

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Pei-Fang Tang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stroke; 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; 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.
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
10-meter walk test	up to 4 weeks, change from baseline to 4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Functional MRI (fMRI), diffusion spectrum imaging (DSI)	up to 4 weeks, change from baseline to 4 weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Pei-Fang Tang, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: August 8, 2013
• First Submitted That Met QC Criteria: August 29, 2013
• First Posted (Estimate): September 4, 2013

Study Record Updates

• Last Update Posted (Estimate): September 4, 2013
• Last Update Submitted That Met QC Criteria: August 29, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: task-oriented training, long-term effects, plasticity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 200812148R