Perturbation-Based Treadmill Training to Prevent Unrecovered Falls in Geriatric Patients (NCT06652828) | Clinical Trial Compass
RecruitingNot Applicable
Perturbation-Based Treadmill Training to Prevent Unrecovered Falls in Geriatric Patients
Germany396 participantsStarted 2024-11-25
Plain-language summary
The goal of this clinical trial is to determine the effectiveness of perturbation-based balance training (PBT) in preventing unrecovered falls among geriatric patients aged ≥70 years with a prospective fall risk of ≥40%. The study will also assess the safety and feasibility of PBT. The main research questions are:
A total of 396 participants will receive 9 training sessions of either PBT or conventional treadmill training and will attend an assessment before and after the intervention, as well as 6 and 12 months follow up. Falls will be documented throughout the entire study period using calendars, telephone interviews, and proxy information. The primary outcome, unrecovered falls, will be recorded after the end of the intervention until 12 months follow up.
Who can participate
Age range
70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥ 70 years
* ≥40% prospective fall risk for the following year according to the Fall Risk Assessment Tool (FRAT-up)
* Walking distance ≥ 70 m in the 2 Minute Walk Test
* Possibility to reach the study site at least via taxi
* Written informed consent, obtained according to international guidelines and local laws
Exclusion Criteria:
* MoCA score \< 10 pts (or MMSE \< 17 pts)
* Performing a Timed up and Go test (TUG) \<10 s
* Leg amputation
* Osteosynthesis or joint replacement of lower extremities within the past 6 weeks.
* Blindness
* Parkinson's disease with Hoehn and Yahr stage \> 3
* Body weight \>135 kg and height \>185 cm
* Life-expectancy \<12 months, instable or severe illness
* Inability to communicate verbally and coorporate appropriatly
* (Prior) participation perturbation training programs
* Gait-relevant foot-drop paresis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of unrecovered falls
Timeframe: Continuously from intervention end until 12 months after the end of the intervention