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Not yet recruitingNCT07654335PACE-RUpdated Jun 24, 2026

Experimental PBT Study in Fall-prone Subjects

An interventional study of PBT in Stroke and Aging, sponsored by University Rehabilitation Institute, Republic of Slovenia. Not yet recruiting at 1 site in Slovenia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by University Rehabilitation Institute, Republic of Slovenia · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stroke
  • Aging

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Keywords

  • Accidental Falls
  • Walking
  • Fall prevention
  • Perturbation-based training
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 50 is close to the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University Rehabilitation Institute, Republic of Slovenia is the lead sponsor of 21 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study 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).

    Device: PBT

  • 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

Interventions

  • DevicePBT

    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

06

What researchers measure

Primary outcomes

  1. Perturbation strength

    Perturbation strength that can be reliably counteracted - difference score (minimum 0N, no upper limit, stronger perturbation means better outcome, larger difference means better outcome)

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

Secondary outcomes

  1. mini-BESTest

    Mini Balance Evaluation Systems Test - difference score (score range 0-28, higher score means better outcome, larger difference means better outcome)

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

  2. ABC Scale

    Activities-Specific Balance Confidence Scale - difference score (score range 0%-100%, higher score means better outcome, larger difference means better outcome)

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

Other outcomes

  1. Adverse events

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

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

07

Study locations

1 site
08

References and documents

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. PubMed 41336813 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07654335
Lead sponsor
University Rehabilitation Institute, Republic of Slovenia
Responsible party
Sponsor
First posted
Jun 17, 2026
Start date
Sep 2026 (estimated)
Primary completion
Sep 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
Jun 24, 2026

Study contacts

Katja Groleger Sršen, MD, PhD
Contact
katja.groleger@ir-rs.si
+386 1 4758283
Zlatko Matjačić, PhD
principal investigator · University Rehabilitation Institute, Republic of Slovenia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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