Multicenter Rehabilitation Study in Acute Stroke

Phase 2

• Conditions: Stroke
• Interventions: Other: gait-oriented rehabilitation

• Registration Number: NCT00849303
• Lead Sponsor: University of Jyvaskyla

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Status Verified: 2009-02
• Study First Submitted: 2009-02-20
• Study First Submitted QC: 2009-02-20
• Last Update Submitted: 2009-02-20
• Study First Posted: 2009-02-23
• Last Update Posted: 2009-02-23
• Primary Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
earlier gait-oriented rehabilitation	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.
later gait-oriented rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
Functional Ambulatory Category	4 measures during six months
Barthel Index	4 measures during 6 months

Secondary Outcome Measures

Name	Time	Method
Functional Status Questionnaire	4 measures during 6 months
Geriatric Depression Scale -15	4 measures during 6 months
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
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

Trial Locations

Locations (4)

Tampere university hospital; 🇫🇮 Tampere, Finland

Middle Finland central hospital and Kinkomaa hospital; 🇫🇮 Jyväskylä, Finland

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Brain Research and Rehabilitation Center Neuron; 🇫🇮 Kuopio, Finland