Gait-Oriented Rehabilitation at Different Phases in Patients With Acute Stroke - Multicenter Randomized Controlled Trial.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- University of Jyvaskyla
- Enrollment
- 80
- Locations
- 4
- Primary Endpoint
- Functional Ambulatory Category
- Last Updated
- 17 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
- •no voluntary movement in the leg of the affected side
- •BI \<25 or \>75
- •severe malposition of joints
- •severe cognitive or communicative disorders
Outcomes
Primary Outcomes
Functional Ambulatory Category
Time Frame: 4 measures during six months
Barthel Index
Time Frame: 4 measures during 6 months
Secondary Outcomes
- 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)