NCT00849303

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2 stroke

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 23, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

February 23, 2009

Status Verified

February 1, 2009

Enrollment Period

2.9 years

First QC Date

February 20, 2009

Last Update Submit

February 20, 2009

Conditions

Stroke

Keywords

strokerehabilitationgaittimingtranscranial magnetic stimulation

Outcome Measures

Primary Outcomes (2)

  • Functional Ambulatory Category

    4 measures during six months

  • Barthel Index

    4 measures during 6 months

Secondary Outcomes (11)

  • 10 meters's walking speed

    4 measures during 6 months

  • 6 minutes' walking distance

    4 measures during 6 months

  • Berg Balance Scale

    4 measures during 6 months

  • Functional Status Questionnaire

    4 measures during 6 months

  • Geriatric Depression Scale -15

    4 measures during 6 months

  • +6 more secondary outcomes

Study Arms (2)

earlier gait-oriented rehabilitation

EXPERIMENTAL

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

later gait-oriented rehabilitation

ACTIVE COMPARATOR

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

Interventions

gait-oriented rehabilitationOTHER

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.

earlier gait-oriented rehabilitation

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Middle Finland central hospital and Kinkomaa hospital

Jyväskylä, 40100, Finland

NOT YET RECRUITING

Kuopio University Hospital

Kuopio, 70211, Finland

RECRUITING

Brain Research and Rehabilitation Center Neuron

Kuopio, 71130, Finland

RECRUITING

Tampere university hospital

Tampere, 33520, Finland

NOT YET RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Sinikka H Peurala, PhD, PT

CONTACT

+358 14 260 2196sinikka.h.peurala@jyu.fi

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 20, 2009

First Posted

February 23, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2011

Last Updated

February 23, 2009

Record last verified: 2009-02

Locations

FI(4)