Multicenter Rehabilitation Study in Acute Stroke
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Jyvaskyla.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Jyvaskyla
Collaborators:
The Hospital District of Northern Savo(grant # EVO477345)
Academy of Finland
Brain Research and Rehabilitation Center Neuron (grant # 1/2009)
Information provided by:
University of Jyvaskyla
ClinicalTrials.gov Identifier:
NCT00849303
First received: February 20, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Other: gait-oriented rehabilitation |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Gait-Oriented Rehabilitation at Different Phases in Patients With Acute Stroke - Multicenter Randomized Controlled Trial. |
Resource links provided by NLM:
Further study details as provided by University of Jyvaskyla:
Primary Outcome Measures:
- Functional Ambulatory Category [ Time Frame: 4 measures during six months ] [ Designated as safety issue: No ]
- Barthel Index [ Time Frame: 4 measures during 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 10 meters's walking speed [ Time Frame: 4 measures during 6 months ] [ Designated as safety issue: No ]
- 6 minutes' walking distance [ Time Frame: 4 measures during 6 months ] [ Designated as safety issue: No ]
- Berg Balance Scale [ Time Frame: 4 measures during 6 months ] [ Designated as safety issue: No ]
- Functional Status Questionnaire [ Time Frame: 4 measures during 6 months ] [ Designated as safety issue: No ]
- Geriatric Depression Scale -15 [ Time Frame: 4 measures during 6 months ] [ Designated as safety issue: No ]
- Beck Depression Intervention modified by Raitasalo [ Time Frame: 4 measures during 6 months ] [ Designated as safety issue: No ]
- Modified Motor Assessment Scale [ Time Frame: 4 measures during 6 months ] [ Designated as safety issue: No ]
- Postural sway by Good Balance [ Time Frame: 3-4 measures during 6 months ] [ Designated as safety issue: No ]
- spatio-temporal gait analysis by GaitRite [ Time Frame: 3-4 measures during 6 months ] [ Designated as safety issue: No ]
- WHOQOF-BREF [ Time Frame: at end and at 6 months' follow-up ] [ Designated as safety issue: No ]
- TMS responses (MT,MEPs,SP,SICI) [ Time Frame: 4 measures during 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2009 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
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 within 10 days since stroke onset.
|
|
Active Comparator: 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.
|
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.
|
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849303
Contacts
| Contact: Sinikka H Peurala, PhD, PT | +358 14 260 2196 | sinikka.h.peurala@jyu.fi |
Locations
| Finland | |
| Middle Finland central hospital and Kinkomaa hospital | Not yet recruiting |
| Jyväskylä, Finland, 40100 | |
| Kuopio University Hospital | Recruiting |
| Kuopio, Finland, 70211 | |
| Brain Research and Rehabilitation Center Neuron | Recruiting |
| Kuopio, Finland, 71130 | |
| Tampere university hospital | Not yet recruiting |
| Tampere, Finland, 33520 | |
Sponsors and Collaborators
University of Jyvaskyla
The Hospital District of Northern Savo(grant # EVO477345)
Academy of Finland
Brain Research and Rehabilitation Center Neuron (grant # 1/2009)
More Information
No publications provided
| Responsible Party: | Sinikka H Peurala, Post doctoral researcher, University of Jyväskylä/Department of Health Sciences/Finnish Centre for Interdisciplinary Gerontology |
| ClinicalTrials.gov Identifier: | NCT00849303 History of Changes |
| Other Study ID Numbers: | 5772765, Academy of Finland 114291 |
| Study First Received: | February 20, 2009 |
| Last Updated: | February 20, 2009 |
| Health Authority: | Finland: Ethics Committee |
Keywords provided by University of Jyvaskyla:
|
stroke rehabilitation gait timing transcranial magnetic stimulation |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 23, 2013