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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01570920
Other study ID # 2008/04JUIL/193
Secondary ID
Status Completed
Phase N/A
First received March 30, 2010
Last updated April 2, 2012
Start date September 2009
Est. completion date March 2011

Study information

Verified date April 2012
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Chronic stroke patients (>6 months) fulfilling including criteria were trained during 3 months. The physical training program was based on walking.


Description:

Participants had been evaluated 4 times during a long follow-up period of 7 months. Activity limitations were assessed at baseline (enrollment time point), 1 month, 4 months and 7 months later.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date March 2011
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Stroke onset > or = 6 months

- Able to walk without human assistance (may use walking aid)

- Sign informed consent form

- Approval from physician for participation in study

- Live in Belgium or in Benin

Exclusion Criteria:

- cardiac history of active unstable angina, recent (less than 3 months) myocardial infarction, or congestive heart failure

- orthopedic, circulatory, or chronic pain conditions restricting exercise;

- dementia;

- severe receptive or global aphasia with inability to follow 2-step commands;

- co-morbid non-stroke neurological disorder that impairs mobility (e.g. MS or Parkinson's);

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
physical training
walking many times a week

Locations

Country Name City State
Belgium Institut of Neuroscience (IoNS) / UCL, 5375 Brussels

Sponsors (1)

Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary ACTIVLIM-Stroke (Activity limitations measures) mainly self-reported outcomes measures 7 months Yes
Secondary Stroke Impairment Stroke related impairment are assessed with specific outcomes measures (SIAS, BBS, ...). 7 months Yes
Secondary Walking ability Walking ability is assessed throuht walking speed and walking endurance 7 months Yes
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