Multicenter Rehabilitation Study in Acute Stroke

Gait-Oriented Rehabilitation at Different Phases in Patients With Acute Stroke - Multicenter Randomized Controlled Trial.

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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Other: gait-oriented rehabilitation; Other: gait-oriented rehabilitation

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Finland
  • Jyväskylä, Finland, 40100
    • Not yet recruiting
    • Middle Finland central hospital and Kinkomaa hospital
  • Kuopio, Finland, 70211
    • Recruiting
    • Kuopio University Hospital
  • Kuopio, Finland, 71130
    • Recruiting
    • Brain Research and Rehabilitation Center Neuron
  • Tampere, Finland, 33520
    • Not yet recruiting
    • Tampere University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; 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.
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 within 10 days since stroke onset.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Functional Ambulatory Category	4 measures during six months
Barthel Index	4 measures during 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Jyvaskyla
• Collaborators: Academy of Finland; Northern Savo Hospital District; Brain Research and Rehabilitation Center Neuron (grant # 1/2009)

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ANTICIPATED): December 1, 2011

Study Registration Dates

• First Submitted: February 20, 2009
• First Submitted That Met QC Criteria: February 20, 2009
• First Posted (ESTIMATE): February 23, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): February 23, 2009
• Last Update Submitted That Met QC Criteria: February 20, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: stroke; gait; rehabilitation; transcranial magnetic stimulation; timing
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 5772765; Academy of Finland 114291