Aging, Stroke
Conditions
Keywords
Accidental Falls, Walking, Fall prevention, Perturbation-based training
Brief summary
The study will investigate safety, usability, feasibility and preliminary efficacy of perturbation-based training in participants post-stroke and older adults with mild balance deficits. Both group will receive three weks of training. The primary outcome measure will be derived from laboratory-induced falls.
Detailed description
Two convenience samples will be recruited to serve as self-controls, 20 post-stroke adults and 30 community-dwelling older adults. Participants post stroke will be recruited after discharge from their regular rehabilitation. Each subject will undergo individually customised perturbation-based training sessions with safety harnesses. The participants will be assessed at four time points: at baseline, after 3 weeks (at the beginning of training), at the end of 3-week training, and at 3-week follow-up. Safety, usability and efficacy of training will be evaluated using slip-, trip- and platform-movement-based perturbations induced by a Stewart platform and dual-belt treadmill, whereby the perturbation strength that can be reliably counteracted will be recorded, and using standardised clinical outcome measures.
Interventions
DEVICEPBT
Each subject will undergo 9 perturbation-based training sessions with safety harnesses, and the device will deliver waist pulls during treadmill walking. Training sessions will be individually customised. Perturbation intensity will be progressively increased by a physiotherapist according to the subject's abilities. Training sessions will last approximately 30 minutes, 2-3 times per week.
Sponsors
University Rehabilitation Institute, Republic of Slovenia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Two groups, each group will follow the ABA protocol with A meaning no intervention and B meaning intervention. There will therefore be four assessment points.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
for both arms: * ability for independent community walking without aids; * sufficient cognitive, visual, and communication abilities for study participation.
Exclusion criteria
for both arms: * musculoskeletal impairments; * cardiovascular health-related problems; * other health conditions that could interfere with the training. Additional Inclusion Criteria for post-stroke patients: * discharge from their regular rehabilitation; * at least 6 months after first unilateral cerebral stroke; * 18 to 70 years of age; * absence of additional neurologic conditions. Additional Inclusion Criteria for older adults: * age 65 to 75 years; * no known health-related problems significantly affecting balance and walking.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perturbation strength | Difference between the two assessments - one day before the first and one day after the last training session | Perturbation strength that can be reliably counteracted - difference score (minimum 0N, no upper limit, stronger perturbation means better outcome, larger difference means better outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mini-BESTest | Difference between the two assessments - one day before the first and one day after the last training session | Mini Balance Evaluation Systems Test - difference score (score range 0-28, higher score means better outcome, larger difference means better outcome) |
| ABC Scale | Difference between the two assessments - one day before the first and one day after the last training session | Activities-Specific Balance Confidence Scale - difference score (score range 0%-100%, higher score means better outcome, larger difference means better outcome) |
Countries
Slovenia
Contacts
CONTACTKatja Groleger Sršen, MD, PhD
PRINCIPAL_INVESTIGATORZlatko Matjačić, PhD
University Rehabilitation Institute, Republic of Slovenia
Outcome results
None listed