Experimental PBT Study in Fall-prone Subjects

Sponsor
University Rehabilitation Institute, Republic of Slovenia
Study ID
NCT07654335
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jun 17, 2026
Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 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).
  • Active Comparator: 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).

Primary Outcome Measure

Perturbation strength [ Time Frame: Difference between the two assessments - one day before the first and one day after the last training session ]

Central Contacts

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