Multicenter Rehabilitation Study in Acute Stroke

Study Overview
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Brief Summary
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The purpose of the first part of this study is to understand plastic brain mechanisms associated with successful gait-oriented stroke rehabilitation. Patients are randomized to receive intensive in-patient multiprofessional rehabilitation at different time points. One group will receive rehabilitation immediately after an acute care at the neurological clinic (8 days) and one group 5 weeks after the insult. Patients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy. In addition to selected parameters measuring brain plasticity, detailed assessments of functional abilities including motor ability and quality of life will be performed. A novel tool, MR-image navigated transcranial magnetic stimulation (TMS) is utilized in assessing cortical excitability in relation to stroke, time, rehabilitation, and recovery.

Official Title
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Gait-Oriented Rehabilitation at Different Phases in Patients With Acute Stroke - Multicenter Randomized Controlled Trial.

Conditions
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Stroke

Intervention / Treatment
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* Other: gait-oriented rehabilitation
* Other: gait-oriented rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: first supratentorial stroke or no significant disturbance from an earlier stroke (Modified Ranking Scale, MRS 0-2) time since onset of stroke no more than 10 days Functional Ambulatory Category (FAC) 0-3 voluntary movement in the leg of the affected side Barthel Index (BI) 25-75 points- no unstable cardiovascular disease Body Mass Index (BMI) <32 no severe malposition of joints no severe cognitive or communicative disorders no other health-related or social barriers to participate intensive rehabilitation Exclusion Criteria: ICH, or MRS >2 time since onset of stroke more than 10 days FAC >3 no voluntary movement in the leg of the affected side BI <25 or >75 severe malposition of joints severe cognitive or communicative disorders

Ages Eligible for Study
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Minimum Age: 55 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: earlier gait-oriented rehabilitation<br>Patients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy 60 min daily. | Other: gait-oriented rehabilitation<br>* Patients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy 60 min daily.Patients starts within 10 days since stroke onset.<br>|
| Active Comparator: later gait-oriented rehabilitation<br>Patients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy 60 min daily. | Other: gait-oriented rehabilitation<br>* Patients practise walking every workday for 60 min (actual 30min) either on a treadmill or on a gait trainer for four weeks, and receive also other physiotherapy 60 min daily.Patients starts five weeks after stroke onset.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Ambulatory Category |  | 4 measures during six months | 
| Barthel Index |  | 4 measures during 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 meters's walking speed |  | 4 measures during 6 months | 
| 6 minutes' walking distance |  | 4 measures during 6 months | 
| Berg Balance Scale |  | 4 measures during 6 months | 
| Functional Status Questionnaire |  | 4 measures during 6 months | 
| Geriatric Depression Scale -15 |  | 4 measures during 6 months | 
| Beck Depression Intervention modified by Raitasalo |  | 4 measures during 6 months | 
| Modified Motor Assessment Scale |  | 4 measures during 6 months | 
| Postural sway by Good Balance |  | 3-4 measures during 6 months | 
| spatio-temporal gait analysis by GaitRite |  | 3-4 measures during 6 months | 
| WHOQOF-BREF |  | at end and at 6 months' follow-up | 
| TMS responses (MT,MEPs,SP,SICI) |  | 4 measures during 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, gait, timing, transcranial magnetic stimulation, stroke