Health TrialsbyHealthPanel

Experimental PBT Study in Fall-prone Subjects

ConditionsStrokeAging
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Rehabilitation Institute, Republic of Slovenia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ability for independent community walking without aids;

sufficient cognitive, visual, and communication abilities for study participation.

Disqualifiers

musculoskeletal impairments;

cardiovascular health-related problems;

other health conditions that could interfere with the training.

discharge from their regular rehabilitation;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Post-stroke patientsExperimental treatment 1 intervention
Group B: Elderly adultsActive comparator 1 intervention

Trial outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Rehabilitation Institute, Republic of Slovenia

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: