Experimental PBT Study in Fall-prone Subjects (PACE-R)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Aging
• Intervention / Treatment: Device: PBT

Detailed Description

We will recruit two convenience samples 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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katja Groleger Sršen, MD, PhD; Phone Number: +386 1 4758283; Email: katja.groleger@ir-rs.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Rehabilitation Institute, Republic of Slovenia
    • Contact: Urška Puh, PT, PhD; Phone Number: +386 1 4758152; Email: urska.puh@ir-rs.si

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	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.; Other Names: PACE-R
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).	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.; Other Names: PACE-R

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
mini-BESTest	Mini Balance Evaluation Systems Test - difference score	Difference between the two assessments - one day before the first and one day after the last training session
ABC Scale	Activities-Specific Balance Confidence Scale - difference score	Difference between the two assessments - one day before the first and one day after the last training session

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Number of adverse events (fatigue, pain, secured falls) during training	During all the nine training sessions across the three weeks

Collaborators and Investigators

• Sponsor: University Rehabilitation Institute, Republic of Slovenia
• Investigators: Principal Investigator: Zlatko Matjačić, PhD, University Rehabilitation Institute, Republic of Slovenia

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: June 12, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Walking; Fall prevention; Accidental Falls; Perturbation-based training
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: URIS202601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No