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Multicenter Rehabilitation Study in Acute Stroke

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ClinicalTrials.gov Identifier: NCT00849303
Recruitment Status : Unknown
Verified February 2009 by University of Jyvaskyla.
Recruitment status was:  Recruiting
First Posted : February 23, 2009
Last Update Posted : February 23, 2009
Sponsor:
Collaborators:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Stroke Other: gait-oriented rehabilitation Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gait-Oriented Rehabilitation at Different Phases in Patients With Acute Stroke - Multicenter Randomized Controlled Trial.
Study Start Date : January 2009
Estimated Primary Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arms and Interventions

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.
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.


Outcome Measures

Primary Outcome Measures :
  1. Functional Ambulatory Category [ Time Frame: 4 measures during six months ]
  2. Barthel Index [ Time Frame: 4 measures during 6 months ]

Secondary Outcome Measures :
  1. 10 meters's walking speed [ Time Frame: 4 measures during 6 months ]
  2. 6 minutes' walking distance [ Time Frame: 4 measures during 6 months ]
  3. Berg Balance Scale [ Time Frame: 4 measures during 6 months ]
  4. Functional Status Questionnaire [ Time Frame: 4 measures during 6 months ]
  5. Geriatric Depression Scale -15 [ Time Frame: 4 measures during 6 months ]
  6. Beck Depression Intervention modified by Raitasalo [ Time Frame: 4 measures during 6 months ]
  7. Modified Motor Assessment Scale [ Time Frame: 4 measures during 6 months ]
  8. Postural sway by Good Balance [ Time Frame: 3-4 measures during 6 months ]
  9. spatio-temporal gait analysis by GaitRite [ Time Frame: 3-4 measures during 6 months ]
  10. WHOQOF-BREF [ Time Frame: at end and at 6 months' follow-up ]
  11. TMS responses (MT,MEPs,SP,SICI) [ Time Frame: 4 measures during 6 months ]

Eligibility Criteria

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Kuopio University Hospital Recruiting
Kuopio, Finland, 70211
Brain Research and Rehabilitation Center Neuron Recruiting
Kuopio, Finland, 71130
Tampere university hospital Not yet recruiting
Tampere, Finland, 33520
Sponsors and Collaborators
University of Jyvaskyla
Northern Savo Hospital District
Academy of Finland
Brain Research and Rehabilitation Center Neuron (grant # 1/2009)
More Information

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
First Posted: February 23, 2009    Key Record Dates
Last Update Posted: February 23, 2009
Last Verified: February 2009

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

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