Multicenter Rehabilitation Study in Acute Stroke

Recruiting

Phase 2/3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Gait-oriented rehabilitation Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: earlier gait-oriented rehabilitation
    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.
    ARM 2: Kind: Experimental
    Label: later gait-oriented rehabilitation
    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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Caregiver, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Functional Ambulatory Category 4 measures during six months No
Primary Barthel Index 4 measures during 6 months No
Secondary 10 meters's walking speed 4 measures during 6 months No
Secondary 6 minutes' walking distance 4 measures during 6 months No
Secondary Berg Balance Scale 4 measures during 6 months No
Secondary Functional Status Questionnaire 4 measures during 6 months No
Secondary Geriatric Depression Scale -15 4 measures during 6 months No
Secondary Beck Depression Intervention modified by Raitasalo 4 measures during 6 months No
Secondary Modified Motor Assessment Scale 4 measures during 6 months No
Secondary Postural sway by Good Balance 3-4 measures during 6 months No
Secondary spatio-temporal gait analysis by GaitRite 3-4 measures during 6 months No
Secondary WHOQOF-BREF at end and at 6 months' follow-up No
Secondary TMS responses (MT,MEPs,SP,SICI) 4 measures during 6 months No

Sponsors