NCT06652828 Perturbation-Based Treadmill Training to Prevent Unrecovered Falls in Geriatric Patients
| NCT ID | NCT06652828 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oldenburg |
| Condition | Fall Prevention |
| Study Type | INTERVENTIONAL |
| Enrollment | 396 participants |
| Start Date | 2024-11-25 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 396 participants in total. It began in 2024-11-25 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Tania Zieschang, Prof. Dr. med.
PRINCIPAL INVESTIGATOR
Carl von Ossietzky University Oldenburg
Frequently Asked Questions
Who can join the NCT06652828 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Fall Prevention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06652828 currently recruiting?
Yes, NCT06652828 is actively recruiting participants. Contact the research team at tania.zieschang@uol.de for enrollment information.
Where is the NCT06652828 trial being conducted?
This trial is being conducted at Heidelberg, Germany, Herne, Germany, Oldenburg, Germany.
Who is sponsoring the NCT06652828 clinical trial?
NCT06652828 is sponsored by University of Oldenburg. The principal investigator is Tania Zieschang, Prof. Dr. med. at Carl von Ossietzky University Oldenburg. The trial plans to enroll 396 participants.