Multicenter Rehabilitation Study in Acute Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00849303
• Other study ID #: 5772765
• Secondary ID: Academy of Finla
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: February 20, 2009
• Last updated: February 20, 2009
• Start date: January 2009

Study information

• Verified date: February 2009
• Source: University of Jyvaskyla
• Contact: Sinikka H Peurala, PhD, PT
• Phone: +358 14 260 2196
• Email: sinikka.h.peurala[@]jyu.fi
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Finland	Middle Finland central hospital and Kinkomaa hospital	Jyväskylä
Finland	Brain Research and Rehabilitation Center Neuron	Kuopio
Finland	Kuopio University Hospital	Kuopio
Finland	Tampere university hospital	Tampere

Sponsors (4)

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

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Ambulatory Category		4 measures during six months	No
Primary	Barthel Index		4 measures during 6 months	No
Secondary	10 meters's walking speed		4 measures during 6 months	No
Secondary	6 minutes' walking distance		4 measures during 6 months	No
Secondary	Berg Balance Scale		4 measures during 6 months	No
Secondary	Functional Status Questionnaire		4 measures during 6 months	No
Secondary	Geriatric Depression Scale -15		4 measures during 6 months	No
Secondary	Beck Depression Intervention modified by Raitasalo		4 measures during 6 months	No
Secondary	Modified Motor Assessment Scale		4 measures during 6 months	No
Secondary	Postural sway by Good Balance		3-4 measures during 6 months	No
Secondary	spatio-temporal gait analysis by GaitRite		3-4 measures during 6 months	No
Secondary	WHOQOF-BREF		at end and at 6 months' follow-up	No
Secondary	TMS responses (MT,MEPs,SP,SICI)		4 measures during 6 months	No