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NCT Number: NCT07654335

Experimental PBT Study in Fall-prone Subjects

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

Location contact

Urška Puh, PT, PhD

CONTACT

[email protected]

+386 1 4758152

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: PACE-R

Primary outcomes

  1. 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

  1. mini-BESTest

    Time frame: 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)

  2. ABC Scale

    Time frame: 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)

Other outcomes

  1. Adverse events

    Time frame: During all the nine training sessions across the three weeks

    Number of adverse events (fatigue, pain, secured falls) during training (fewer events mean better outcome)

Study contacts

Contact information is provided by the study sponsor or research team.

Katja Groleger Sršen, MD, PhD

CONTACT

[email protected]

+386 1 4758283

Sponsors and collaborators

Lead sponsor

University Rehabilitation Institute, Republic of Slovenia

Other

Registry information

Official study title

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

Acronym: PACE-R

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 17, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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