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Status unknownNCT00849303Updated Feb 23, 2009

Multicenter Rehabilitation Study in Acute Stroke

A Phase 2/3 interventional study of gait-oriented rehabilitation and gait-oriented rehabilitation in Stroke, sponsored by University of Jyvaskyla. Status unknown at 4 sites in Finland. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2009-02-23.

Sponsored by University of Jyvaskyla · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke

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Keywords

  • stroke
  • rehabilitation
  • gait
  • timing
  • transcranial magnetic stimulation
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's planned enrollment of 80 is above the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University of Jyvaskyla is the lead sponsor of 25 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Othergait-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.

  • Othergait-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.

06

What researchers measure

Primary outcomes

  1. Functional Ambulatory Category

    Time frame: 4 measures during six months

  2. Barthel Index

    Time frame: 4 measures during 6 months

Secondary outcomes

  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

07

Study locations

2 of 4 sites recruiting
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00849303
Lead sponsor
University of Jyvaskyla
Collaborators
Northern Savo Hospital District, Academy of Finland, Brain Research and Rehabilitation Center Neuron (grant # 1/2009)
First posted
Feb 23, 2009
Start date
Jan 2009
Primary completion
Dec 2011 (estimated)
Last update
Feb 23, 2009

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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