Multicenter Rehabilitation Study in Acute Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

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.

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Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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earlier gait-oriented rehabilitation

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.

Group Type EXPERIMENTAL

gait-oriented rehabilitation

Intervention Type OTHER

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.

later gait-oriented rehabilitation

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.

Group Type ACTIVE_COMPARATOR

gait-oriented rehabilitation

Intervention Type OTHER

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.

Interventions

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gait-oriented rehabilitation

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.

Intervention Type OTHER

gait-oriented rehabilitation

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.

Intervention Type OTHER

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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No