Early Functional Training in Acute Stroke Inpatient Ward

Study Overview
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Brief Summary
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To investigate the difference between two models of an early intervention program (focused on mobility function) in the functional recovery 3 months post stroke in a group of patients with acute ischemic stroke while in acute inpatient ward hospitalization.

Detailed Description
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Patients with acute stroke admit into an acute inpatient ward who meet study criteria and provide institutional-reviewed consent form will be randomly assigned into either model 1 or model 2 of an early functional training program. Participants in model 1 group will receive 2 sessions of functional training per day whereas those in model 2 group will receive 1 session of functional training and 1 session of friendly visit and education per day. The following outcomes will be measured at admission, at discharge and at 3 months post stroke: Barthel index (BI), Postural Assessment Scale for Stroke (PASS), Mobility Scale for Acute Stroke (MASA), and usual gait speed (UGS). The rater is blinded to participants' group membership.

Official Title
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The Effect of Two Models of an Early Intervention Program on Functional Recovery at Three Months to Acute Stroke Patients: A Randomized Controlled Trial

Conditions
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Acute Stroke

Intervention / Treatment
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* Other: Early intervention (Mobility functional training)
* Other: Sham intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient with acute ischemic stroke / ICH referred for early rehabilitation, aged 20 years or more, Exclusion Criteria: able to walk independently and safely at admission, unable to understand three simple comments, unable to recovery even with appropriate medical management, serious condition require ICU care, terminal illness for hospice care, waiting to transfer to long term care facilities

Ages Eligible for Study
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Minimum Age: 20 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Model 1<br>Participants will receive 2 sessions of functional training per day, 15-min per session. | Other: Early intervention (Mobility functional training)<br>* functional training focused on mobility (bed mobility, sitting balance, standing balance, and ambulation)<br>|
| Active Comparator: Model 2<br>Participants will receive 1 session of functional training and 1 session of sham intervention (therapist visiting and education) per day, 15-min per session. | Other: Early intervention (Mobility functional training)<br>* functional training focused on mobility (bed mobility, sitting balance, standing balance, and ambulation)<br>Other: Sham intervention<br>* friendly visit and education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel index (BI) | The total score range is 0 to 100 points. Higher score indicate better performance. | up to 2 weeks | 
| Barthel index (BI) | The total score range is 0 to 100 points. Higher score indicate better performance. | at 3 months post stroke | 
| Postural Assessment Scale for Stroke Patient (PASS) | The total score range is 0 to 36 points. Higher score indicate better performance. | Baseline | 
| Postural Assessment Scale for Stroke Patient (PASS) | The total score range is 0 to 36 points. Higher score indicate better performance. | up to 2 weeks | 
| Postural Assessment Scale for Stroke Patient (PASS) | The total score range is 0 to 36 points. Higher score indicate better performance. | at 3 months post stroke | 
| Barthel index (BI) | The total score range is 0 to 100 points. Higher score indicate better performance. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usual gait speed | meters per second. Higher score indicate better performance. | Baseline | 
| Usual gait speed | meters per second. Higher score indicate better performance. | up to 2 weeks | 
| Usual gait speed | meters per second. Higher score indicate better performance. | at 3 months post stroke | 
| Mobility Scale for Acute Stroke (MSAS) | The total score range is 6 to 36 points. Higher score indicate better performance. | Baseline | 
| Mobility Scale for Acute Stroke (MSAS) | The total score range is 6 to 36 points. Higher score indicate better performance. | up to 2 weeks | 
| Mobility Scale for Acute Stroke (MSAS) | The total score range is 6 to 36 points. Higher score indicate better performance. | at 3 months post stroke |