Does the Enhanced Rehabilitation Programs Facilitate the Motor Recovery After Stroke?

Study Overview
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Brief Summary
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Study purpose This study will explore whether an additional rehabilitation program that focus on either upper or lower extremity training facilitate the recovery in upper or lower extremity. The recovery in both neurological status and motor functions will be explored.

Detailed Description
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Design A single-blinded (assessor-blinded) randomized controlled trial. Interventions The participants will be randomly assigned into two experiment groups (enhanced upper extremity program; and enhanced lower-extremity program). Both groups receive routine rehabilitation including daily 50 mins of physical therapy and 50 mins of occupational therapy. The enhanced upper extremity program group receives additional daily 50 mins program focusing on training of the hemiplegic upper extremity, while the enhanced lower-extremity program group receives additional daily 50 mins program focusing on training of the hemiplegic lower extremity. The participants receive 20-day training over a 4-week period. The additional program is designed to be specific to either upper-extremity or lower-extremity. Accordingly, one group can be used as the control group of the other one.

Official Title
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Does the Enhanced Rehabilitation Programs Facilitate the Motor Recovery After Stroke? A Multicenter Randomized Controlled Study (TIARAS Trial)

Conditions
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Poststroke/CVA Hemiparesis

Intervention / Treatment
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* Other: UFT
* Other: LFT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First-ever stroke with the onset 10-90 days prior to the enrollment Age: 20-80y With a hemiplegic upper extremity with Brunnstrom stage in I IV Able to understand simple orders (1-step orders, such as raise your hand, touch your head….) Totally independent in activity of daily life before the onset of stroke Exclusion Criteria: Incompliance to the assessments or interventions due to unstable medical condition, abnormal cognition, or other conditions. Stroke of brainstem or cerebellum Had received craniotomy or ventriculoperitoneal shunting Needs of orthoses in walking before the onset of stroke Had had motor dysfunctions (eg, amputation, cerebral palsy, poliomyelitis or other neuromuscular diseases) before the stroke. Intracranial hemorrhage caused by artereovenous malformation, aneurysm, or tumor Able to walk independently for more than 50 meters.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: enhanced upper-extremity program, EUEP<br>Both groups receive routine rehabilitation including daily 50 mins of physical therapy and 50 mins of occupational therapy. The EUP group receives additional daily 50 mins program focusing on training of the hemiplegic upper extremity. The participants receive 20-day training over a 4-weekperiod. The additional program is designed to be specific to either upper-extremity or lower-extremity. Accordingly, one group can be used as the control group of the other one. | Other: UFT<br>* The EUEP group receives additional daily 50 mins program focusing on training of the hemiplegic upper extremity,<br>|
| Experimental: enhanced lower-extremity program,ELLP)<br>Both groups receive routine rehabilitation including daily 50 mins of physical therapy and 50 mins of occupational therapy. The ELP group receives additional daily 50 mins program focusing on training of the hemiplegic lower extremity. The participants receive 20-day training over a4-weekperiod. The additional program is designed to be specific to either upper-extremity or lower-extremity. Accordingly,one group can be used as the control group of the other one. | Other: LFT<br>* The ELEP group receives additional daily 50 mins program focusing on training of the hemiplegic lower extremity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment (upper extremity subscale) | The primary outcome is the change from baseline upper extremity subscale of Fugl-Meyer assessment at the end to 4-wk (post-intervention). | 0-, 4- week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Action Research Arm Test (ARAT) | A test that measures the upper extremity motor functions after the stroke. | 0-, 4-, 8-, 12-, 24 week | 
| Berg Balance Test | A test that measures the balance functions. | 0-, 4-, 8-, 12-, 24 week | 
| Fugl-Meyer Assessment (lower extremity subscale) | The FMA-LE (0-34) measures the lower extremity motor functions after the stroke. | 0-, 4-, 8-, 12-, 24 week | 
| Fugl-Meyer Assessment (upper extremity subscale) | FMA-UE (0-66), the subscale of FMA that measures the poststroke neuro-motor functions. | 0-, 4-, 8-, 12-, 24 week | 
| Time required for 10 meter walking | measuring the walking speed over a 10-meter distance | 0-, 4-, 8-, 12-, 24 week | 
| Stroke Impact Scale | A measure for stroke-specific quality of life | 0-, 4-, 8-, 12-, 24 week | 
| Barthel Index | to measure the activity of daily living | 0-, 4-, 8-, 12-, 24 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intensity, rehabilitation