StrokePACE-RNCT07654335
Experimental PBT Study in Fall-prone Subjects
A study testing PBT in people with Stroke and Aging, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- PBT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSlovenia
- Study dates
- Sep 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ability for independent community walking without aids;
- sufficient cognitive, visual, and communication abilities for study participation.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site
University Rehabilitation Institute, Republic of Slovenia
Ljubljana, 1000
Urška Puh, PT, PhD, +386 1 4758152, urska.puh@ir-rs.si
About this study
Official title: 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.
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.
- Being tested
- PBT
- Keywords
- Accidental Falls, Walking, Fall prevention, Perturbation-based training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBTDevice
Also called PACE-R
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: PBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Difference between the two assessments - one day before the first and one day after the last training session
Secondary outcomes (2)
mini-BESTest
Mini Balance Evaluation Systems Test - difference score (score range 0-28, higher score means better outcome, larger difference means better outcome)
Measured: 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 (score range 0%-100%, higher score means better outcome, larger difference means better outcome)
Measured: Difference between the two assessments - one day before the first and one day after the last training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Rehabilitation Institute, Republic of Slovenia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zlatko Matjačić, PhD, Principal investigator, University Rehabilitation Institute, Republic of Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654335
- Sponsor's protocol ID
- URIS202601
- Acronym
- PACE-R
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Perturbation-based-training Study in Patients After Stroke and Older Adults
- ClinicalTrials.gov ID
- NCT07654335
- Acronym / sponsor ID
- PACE-R / URIS202601
- Keywords
- Accidental Falls, Walking, Fall prevention, Perturbation-based training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Rehabilitation Institute, Republic of SloveniaUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Post-stroke patients | Experimental | Device: PBTEach 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). |
| Elderly adults | Active comparator | Device: PBTEach 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ability for independent community walking without aids;
- sufficient cognitive, visual, and communication abilities for study participation.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBTAlso: PACE-REach 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. | Device | Elderly adults, Post-stroke patients |
Primary outcome
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)
2 secondary outcomes
mini-BESTest
Time frame: Difference between the two assessments - one day before the first and one day after the last training session
ABC Scale
Time frame: Difference between the two assessments - one day before the first and one day after the last training session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Background: PubMed 41336813Olensek 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zlatko Matjačić, PhD principal investigator
University Rehabilitation Institute, Republic of Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PBT in people with Stroke and Aging, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katja Groleger Sršen, MD, PhD (+386 1 4758283, katja.groleger@ir-rs.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07654335, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.