About this trial
The goal of this clinical trial is to learn whether combining moderate to high intensity aerobic exercise with constraint-induced movement therapy (CI therapy) can improve walking ability in adults who have had a stroke. The study will also learn if telerehabilitation at home can support long-term recovery after intensive rehabilitation.
The main questions this study aims to answer are:
* Does moderate to high intensity aerobic exercise before CI therapy improve walking ability, balance and lower extremity function in people with long-lasting gait difficulties after stroke? * Does CI therapy alone lead to similar or different improvements in walking ability, balance or lower extremity function? * Does telerehabilitation help participants maintain or further improve their function after the intensive rehabilitation period?
Researchers will compare two groups. One group will receive 4 weeks of CI therapy, 5 days per week, plus 20 minutes of moderate-to-high-intensity aerobic exercise before the rehabilitation session on 3 of these days, and the other group will receive 4 weeks of CI therapy, 5 days per week, without preparatory aerobic exercise.
After the completion of CI therapy, all participants will be offered an individualized 8-week telerehabilitation program to follow at home. They will use a mobile application to report physical activity and follow instructions for telerehabilitation.
All participants will complete two assessment visits (about 3 hours each), 1-2 weeks before and 1-2 weeks after CI therapy. They will also complete questionnaires electronically after the telerehabilitation program.
Daily activity will be measured twice during the study: once during a week after the intensive rehabilitation and once during a week after the telerehabilitation program. A small movement sensor worn on the thigh will be used. The sensor is attached with a soft strap or an adhesive patch and is comfortable to wear all day. The sensor shows how much a person walks, stands, or sits in everyday life. It is light, does not disturb normal activities, and only collects movement information for the study. An instruction sheet will be included to make it easy to use.
Eligibility criteria
Qualifiers
Age between 18 and 70 years.
History of a first-ever stroke occurring at least 6 months before enrollment.
Independence in personal activities of daily living (e.g., dressing, undressing, and using the toilet).
Ability to take a few steps indoors without a walking aid and without supervision; use of an orthosis is permitted.
Disqualifiers
Unstable cardiovascular disease or exercise-induced epilepsy.
Insufficient cognitive ability to participate in group-based training, including the capacity to understand, follow, and maintain verbal instructions during exercise tasks.
Blood pressure >140/90 mmHg at the first visit.
Trial design
Treatments tested in this trial
- LE-mCIMT-EXE
- LE- mCIMT-TAU
Treatment groups
Locations
Sponsors and collaborators
The Swedish School of Sport and Health Sciences
Lead sponsor
Neurology clinic, Stockholm
Collaborator
Neurocampus, Stockholm
Collaborator
Furuhöjden rehabcenter
Collaborator
Camp pro Ortopedteknik
Collaborator