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Multicenter Rehabilitation Study in Acute Stroke

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Jyvaskyla.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
The Hospital District of Northern Savo(grant # EVO477345)
Academy of Finland
Brain Research and Rehabilitation Center Neuron (grant # 1/2009)
Information provided by:
University of Jyvaskyla
ClinicalTrials.gov Identifier:
NCT00849303
First received: February 20, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Stroke
Other: gait-oriented rehabilitation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gait-Oriented Rehabilitation at Different Phases in Patients With Acute Stroke - Multicenter Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by University of Jyvaskyla:

Primary Outcome Measures:
  • Functional Ambulatory Category [ Time Frame: 4 measures during six months ] [ Designated as safety issue: No ]
  • Barthel Index [ Time Frame: 4 measures during 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 10 meters's walking speed [ Time Frame: 4 measures during 6 months ] [ Designated as safety issue: No ]
  • 6 minutes' walking distance [ Time Frame: 4 measures during 6 months ] [ Designated as safety issue: No ]
  • Berg Balance Scale [ Time Frame: 4 measures during 6 months ] [ Designated as safety issue: No ]
  • Functional Status Questionnaire [ Time Frame: 4 measures during 6 months ] [ Designated as safety issue: No ]
  • Geriatric Depression Scale -15 [ Time Frame: 4 measures during 6 months ] [ Designated as safety issue: No ]
  • Beck Depression Intervention modified by Raitasalo [ Time Frame: 4 measures during 6 months ] [ Designated as safety issue: No ]
  • Modified Motor Assessment Scale [ Time Frame: 4 measures during 6 months ] [ Designated as safety issue: No ]
  • Postural sway by Good Balance [ Time Frame: 3-4 measures during 6 months ] [ Designated as safety issue: No ]
  • spatio-temporal gait analysis by GaitRite [ Time Frame: 3-4 measures during 6 months ] [ Designated as safety issue: No ]
  • WHOQOF-BREF [ Time Frame: at end and at 6 months' follow-up ] [ Designated as safety issue: No ]
  • TMS responses (MT,MEPs,SP,SICI) [ Time Frame: 4 measures during 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2009
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 five weeks after stroke onset.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849303

Contacts
Contact: Sinikka H Peurala, PhD, PT +358 14 260 2196 sinikka.h.peurala@jyu.fi

Locations
Finland
Middle Finland central hospital and Kinkomaa hospital Not yet recruiting
Jyväskylä, Finland, 40100
Brain Research and Rehabilitation Center Neuron Recruiting
Kuopio, Finland, 71130
Kuopio University Hospital Recruiting
Kuopio, Finland, 70211
Tampere university hospital Not yet recruiting
Tampere, Finland, 33520
Sponsors and Collaborators
University of Jyvaskyla
The Hospital District of Northern Savo(grant # EVO477345)
Academy of Finland
Brain Research and Rehabilitation Center Neuron (grant # 1/2009)
  More Information

No publications provided

Responsible Party: Sinikka H Peurala, Post doctoral researcher, University of Jyväskylä/Department of Health Sciences/Finnish Centre for Interdisciplinary Gerontology
ClinicalTrials.gov Identifier: NCT00849303     History of Changes
Other Study ID Numbers: 5772765, Academy of Finland 114291
Study First Received: February 20, 2009
Last Updated: February 20, 2009
Health Authority: Finland: Ethics Committee

Keywords provided by University of Jyvaskyla:
stroke
rehabilitation
gait
timing
transcranial magnetic stimulation

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014