Perturbation-based treadmill training to prevent falls in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.