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Clinical Trials in Germany / NCT06652828
Recruiting Not applicable

Perturbation-Based Treadmill Training to Prevent Unrecovered Falls in Geriatric Patients

NCT06652828 · tracked via the Priya Life Science Germany tracker
Sponsor
University of Oldenburg
Phase
Not applicable
Started
2024-11-25
Last updated
2025-05-14

Condition(s) studied

Fall PreventionExerciseGeriatricsCognitive ImpairmentPerturbation

Investigational drug(s) / intervention(s)

Conventional Treadmill Walking (CTT)Perturbation-Based Balance Training (PBT)

Conventional Treadmill Walking (CTT): The CTT serves as a comparison to PBT. It involves standard treadmill walking without perturbations on the same treadmill. This intervention is conducted over the same defined period as PBT (3-6 weeks), with a matched frequency and exercise time compared to the PBT group for consistency. Participants are secured with safety harnesses while walking.

Perturbation-Based Balance Training (PBT): Overall, 9 training sessions with different objectives and progression regarding perturbation directions, predictability, and intensity will be conducted within 3-6 weeks. During the initial sessions, familiarizing participants with the treadmill and establishing their individual walking pace will be focused. Pace can be individually adjusted in each training session. Participants are secured with safety harnesses while walking.

Study 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

Sex
ALL
Min age
70 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Geriatric Center, Heidelberg University Hospital, Agaplesion Bethanien Krankenhaus Heidelberg Baden-Wurttemberg Recruiting
Department of Geriatric Medicine, University Hospital Marien Hospital Herne - Ruhr-University Bochum Herne North Rhine-Westphalia Recruiting
Carl von Ossietzky Universität, Department für Versorgungsforschung, Abteilung Geriatrie Oldenburg Germany Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06652828 on ClinicalTrials.gov ↗ ← All trials in Germany