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Multicenter Rehabilitation Study in Acute Stroke

Primary Purpose

Stroke

Status
Unknown status
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
gait-oriented rehabilitation
gait-oriented rehabilitation
Sponsored by
University of Jyvaskyla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, rehabilitation, gait, timing, transcranial magnetic stimulation

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Middle Finland central hospital and Kinkomaa hospital
  • Kuopio University HospitalRecruiting
  • Brain Research and Rehabilitation Center NeuronRecruiting
  • Tampere university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

earlier gait-oriented rehabilitation

later gait-oriented rehabilitation

Arm 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.

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.

Outcomes

Primary Outcome Measures

Functional Ambulatory Category
Barthel Index

Secondary Outcome Measures

10 meters's walking speed
6 minutes' walking distance
Berg Balance Scale
Functional Status Questionnaire
Geriatric Depression Scale -15
Beck Depression Intervention modified by Raitasalo
Modified Motor Assessment Scale
Postural sway by Good Balance
spatio-temporal gait analysis by GaitRite
WHOQOF-BREF
TMS responses (MT,MEPs,SP,SICI)

Full Information

First Posted
February 20, 2009
Last Updated
February 20, 2009
Sponsor
University of Jyvaskyla
Collaborators
Northern Savo Hospital District, Academy of Finland, Brain Research and Rehabilitation Center Neuron (grant # 1/2009)
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1. Study Identification

Unique Protocol Identification Number
NCT00849303
Brief Title
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

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, rehabilitation, gait, timing, transcranial magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
earlier gait-oriented rehabilitation
Arm Type
Experimental
Arm 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 Title
later gait-oriented rehabilitation
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
gait-oriented rehabilitation
Intervention 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.Patients starts within 10 days since stroke onset.
Intervention Type
Other
Intervention Name(s)
gait-oriented rehabilitation
Intervention 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.Patients starts five weeks after stroke onset.
Primary Outcome Measure Information:
Title
Functional Ambulatory Category
Time Frame
4 measures during six months
Title
Barthel Index
Time Frame
4 measures during 6 months
Secondary Outcome Measure Information:
Title
10 meters's walking speed
Time Frame
4 measures during 6 months
Title
6 minutes' walking distance
Time Frame
4 measures during 6 months
Title
Berg Balance Scale
Time Frame
4 measures during 6 months
Title
Functional Status Questionnaire
Time Frame
4 measures during 6 months
Title
Geriatric Depression Scale -15
Time Frame
4 measures during 6 months
Title
Beck Depression Intervention modified by Raitasalo
Time Frame
4 measures during 6 months
Title
Modified Motor Assessment Scale
Time Frame
4 measures during 6 months
Title
Postural sway by Good Balance
Time Frame
3-4 measures during 6 months
Title
spatio-temporal gait analysis by GaitRite
Time Frame
3-4 measures during 6 months
Title
WHOQOF-BREF
Time Frame
at end and at 6 months' follow-up
Title
TMS responses (MT,MEPs,SP,SICI)
Time Frame
4 measures during 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sinikka H Peurala, PhD, PT
Phone
+358 14 260 2196
Email
sinikka.h.peurala@jyu.fi
Facility Information:
Facility Name
Middle Finland central hospital and Kinkomaa hospital
City
Jyväskylä
ZIP/Postal Code
40100
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
Individual Site Status
Recruiting
Facility Name
Brain Research and Rehabilitation Center Neuron
City
Kuopio
ZIP/Postal Code
71130
Country
Finland
Individual Site Status
Recruiting
Facility Name
Tampere university hospital
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

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Multicenter Rehabilitation Study in Acute Stroke

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