Experimental Perturbation-based-training Study in Patients After Stroke and Older Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Perturbation strength
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Post-stroke patients
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).
Intervention: PBT (Device)
Elderly adults
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).
Intervention: PBT (Device)
Outcomes
Primary Outcomes
Perturbation strength
Time Frame: 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 Outcomes
- ABC Scale(Difference between the two assessments - one day before the first and one day after the last training session)
- mini-BESTest(Difference between the two assessments - one day before the first and one day after the last training session)