Multicenter Rehabilitation Study in Acute Stroke

University of Jyväskylä

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Stroke

Treatments: Other: gait-oriented rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT00849303

Academy of Finland 114291

5772765

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

earlier gait-oriented rehabilitation

Experimental group

Description:

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.

Treatment:

Other: gait-oriented rehabilitation

Other: gait-oriented rehabilitation

later gait-oriented rehabilitation

Active Comparator group

Description:

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.

Treatment:

Other: gait-oriented rehabilitation

Other: gait-oriented rehabilitation