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Multicenter Rehabilitation Study in Acute Stroke

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00849303
Enrollment
80
Registered
2009-02-23
Start date
2009-01-31
Completion date
Unknown
Last updated
2009-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, rehabilitation, gait, timing, transcranial magnetic stimulation

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.

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.

Sponsors

Northern Savo Hospital District
CollaboratorOTHER
Academy of Finland
CollaboratorOTHER
Brain Research and Rehabilitation Center Neuron (grant # 1/2009)
CollaboratorUNKNOWN
University of Jyvaskyla
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frame
Functional Ambulatory Category4 measures during six months
Barthel Index4 measures during 6 months

Secondary

MeasureTime frame
WHOQOF-BREFat end and at 6 months' follow-up
TMS responses (MT,MEPs,SP,SICI)4 measures during 6 months
10 meters's walking speed4 measures during 6 months
6 minutes' walking distance4 measures during 6 months
Postural sway by Good Balance3-4 measures during 6 months
Functional Status Questionnaire4 measures during 6 months
Geriatric Depression Scale -154 measures during 6 months
Beck Depression Intervention modified by Raitasalo4 measures during 6 months
Modified Motor Assessment Scale4 measures during 6 months
Berg Balance Scale4 measures during 6 months
spatio-temporal gait analysis by GaitRite3-4 measures during 6 months

Countries

Finland

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026