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Experimental PBT Study in Fall-prone Subjects

No phase Interventional Stroke Aging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PBT.
Who it may be relevant to
Registry conditions: Stroke, Aging. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Slovenia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Experimental Perturbation-based-training Study in Patients After Stroke and Older Adults

Overview

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

  • Device PBT
    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.

Primary outcome measures

  • Perturbation strength [Time frame: Difference between the two assessments - one day before the first and one day after the last training session]
Secondary outcome measures (2)
  • mini-BESTest [Time frame: Difference between the two assessments - one day before the first and one day after the last training session]
  • ABC Scale [Time frame: Difference between the two assessments - one day before the first and one day after the last training session]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Slovenia · 1 center
  • University Rehabilitation Institute, Republic of Slovenia — Ljubljana

Publications

  • 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. PMID 41336813

Identifiers

NCT: NCT07654335 · URIS202601

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗