Clinical trial NCT00849303: Multicenter Rehabilitation Study in Acute Stroke
Official title: Gait-Oriented Rehabilitation at Different Phases in Patients With Acute Stroke - Multicenter Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Stroke
Keywords: stroke
rehabilitation
gait
timing
transcranial magnetic stimulation
Lead sponsor: University of Jyvaskyla
Sponsor class: OTHER
Collaborators: name: Northern Savo Hospital District
name: Academy of Finland
name: Brain Research and Rehabilitation Center Neuron (grant # 1/2009)
First posted: 2009-02-23
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Functional Ambulatory Category
timeFrame: 4 measures during six months
measure: Barthel Index
timeFrame: 4 measures during 6 months
Secondary outcomes:
measure: 10 meters's walking speed
timeFrame: 4 measures during 6 months
measure: 6 minutes' walking distance
timeFrame: 4 measures during 6 months
measure: Berg Balance Scale
timeFrame: 4 measures during 6 months
measure: Functional Status Questionnaire
timeFrame: 4 measures during 6 months
measure: Geriatric Depression Scale -15
timeFrame: 4 measures during 6 months
measure: Beck Depression Intervention modified by Raitasalo
timeFrame: 4 measures during 6 months
measure: Modified Motor Assessment Scale
timeFrame: 4 measures during 6 months
measure: Postural sway by Good Balance
timeFrame: 3-4 measures during 6 months
measure: spatio-temporal gait analysis by GaitRite
timeFrame: 3-4 measures during 6 months
measure: WHOQOF-BREF
timeFrame: at end and at 6 months' follow-up
measure: TMS responses (MT,MEPs,SP,SICI)
timeFrame: 4 measures during 6 months
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Middle Finland central hospital and Kinkomaa hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Kuopio
country: Finland
facility: Brain Research and Rehabilitation Center Neuron
city: Tampere
country: Finland
facility: Tampere university hospital
Study officials:
References: