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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-stroke patients | Experimental | Each participant will undergo perturbation-based training and assessment according to an ABA (no intervention/intervention/no intervention) design with assessment at the beginning and end of each phase (four time-points). |
|
| Elderly adults | Active Comparator | Each participant will undergo perturbation-based training and assessment according to an ABA (no intervention/intervention/no intervention) design with assessment at the beginning and end of each phase (four time-points). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBT | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Perturbation strength | Perturbation strength that can be reliably counteracted - difference score (minimum 0N, no upper limit, stronger perturbation means better outcome, larger difference means better outcome) | Difference between the two assessments - one day before the first and one day after the last training session |
| Measure | Description | Time Frame |
|---|---|---|
| mini-BESTest | Mini Balance Evaluation Systems Test - difference score (score range 0-28, higher score means better outcome, larger difference means better outcome) | Difference between the two assessments - one day before the first and one day after the last training session |
| ABC Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of adverse events (fatigue, pain, secured falls) during training (fewer events mean better outcome) | During all the nine training sessions across the three weeks |
Inclusion Criteria for both arms:
Exclusion Criteria for both arms:
Additional Inclusion Criteria for post-stroke patients:
Additional Inclusion Criteria for older adults:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katja Groleger Sršen, MD, PhD | Contact | +386 1 4758283 | katja.groleger@ir-rs.si |
| Name | Affiliation | Role |
|---|---|---|
| Zlatko Matjačić, PhD | University Rehabilitation Institute, Republic of Slovenia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Rehabilitation Institute, Republic of Slovenia | Ljubljana | 1000 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41336813 | Background | Olensek A, Zadravec M, Matjacic Z. A novel methodological approach for inducing slips, trips and pelvic pulls during treadmill walking. Annu Int Conf IEEE Eng Med Biol Soc. 2025 Jul;2025:1-7. doi: 10.1109/EMBC58623.2025.11251529. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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Activities-Specific Balance Confidence Scale - difference score (score range 0%-100%, higher score means better outcome, larger difference means better outcome) |
| Difference between the two assessments - one day before the first and one day after the last training session |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |