Experimental PBT Study in Fall-prone Subjects

NCT07654335 | Not Yet Recruiting

• 1 other identifier: URIS202601
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Aging

Keywords

Accidental Falls; Walking; Fall prevention; Perturbation-based training

Outcome Measures

Primary Outcomes (1)

• Perturbation strength

  Perturbation strength that can be reliably counteracted - difference score

  Difference between the two assessments - one day before the first and one day after the last training session

Secondary Outcomes (2)

• mini-BESTest

  Difference between the two assessments - one day before the first and one day after the last training session

• ABC Scale

  Difference between the two assessments - one day before the first and one day after the last training session

Other Outcomes (1)

• Adverse events

  During all the nine training sessions across the three weeks

Study Arms (2)

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).

Device: PBT

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).

Device: PBT

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.

Also known as: PACE-R

Elderly adults; Post-stroke patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ability for independent community walking without aids;
• sufficient cognitive, visual, and communication abilities for study participation.

You may not qualify if:

• musculoskeletal impairments;
• cardiovascular health-related problems;
• other health conditions that could interfere with the training.
• discharge from their regular rehabilitation;
• at least 6 months after first unilateral cerebral stroke;
• to 70 years of age;
• absence of additional neurologic conditions.
• age 65 to 75 years;
• no known health-related problems significantly affecting balance and walking.

Sponsors & Collaborators

• University Rehabilitation Institute, Republic of Slovenia: lead

Study Sites (1)

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zlatko Matjačić, PhD

  University Rehabilitation Institute, Republic of Slovenia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katja Groleger Sršen, MD, PhD

CONTACT

+386 1 4758283; katja.groleger@ir-rs.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)