Ischemic Cerebrovascular Accident Clinical Trial
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
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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