Perturbation-based treadmill training to prevent falls in older adults
Training at the Limit of Balance Control on a Perturbation Treadmill to Prevent Unrecovered Falls in Geriatric Patients With and Without Cognitive Impairment
This study is testing a special treadmill training program to see if it can help older adults at high risk of falling stay safe and avoid serious falls.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 396 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | University of Oldenburg Academic / other |
| Locations | 3 sites (Heidelberg, Baden-Wurttemberg and 2 other locations) |
| Trial ID | NCT06652828 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of perturbation-based balance training (PBT) in preventing unrecovered falls among geriatric patients aged 70 and older who are at a high risk of falling. A total of 396 participants will be randomly assigned to receive either PBT or conventional treadmill training over nine sessions. The study will assess the primary outcome of unrecovered falls, defined as falls where individuals cannot get up independently, over a 12-month follow-up period. Additional outcomes will include mobility, balance performance, and health-related quality of life, with assessments conducted before, immediately after, and at 6 and 12 months post-intervention.
Who should consider this trial
Good fit: Ideal candidates are geriatric patients aged 70 years and older with a prospective fall risk of 40% or more.
Not a fit: Patients with severe cognitive impairment, certain medical conditions, or those unable to participate in the training may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of falls and improve the quality of life for older adults at risk.
How similar studies have performed: Previous studies have shown promise in using perturbation-based training for fall prevention, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Heidelberg, Baden-Wurttemberg and 2 other locations
- Geriatric Center, Heidelberg University Hospital, Agaplesion Bethanien Krankenhaus — Heidelberg, Baden-Wurttemberg, Germany (Recruiting)
- Department of Geriatric Medicine, University Hospital Marien Hospital Herne - Ruhr-University Bochum — Herne, North Rhine-Westphalia, Germany (Recruiting)
- Carl von Ossietzky Universität, Department für Versorgungsforschung, Abteilung Geriatrie — Oldenburg, Germany (Recruiting)
Study contacts
- Principal investigator: Tania Zieschang, Prof. Dr. med. — Carl von Ossietzky University Oldenburg
- Study coordinator: Tania Prof. Dr. med. Zieschang
- Email: tania.zieschang@uol.de
- Phone: +49 441 798-4760
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.