Actively Recruiting

Phase Not Applicable
Age: 70Years +
All Genders
NCT06652828

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

Led by University of Oldenburg · Updated on 2025-05-14

396

Participants Needed

3

Research Sites

126 weeks

Total Duration

On this page

Sponsors

U

University of Oldenburg

Lead Sponsor

M

Marienhospital Herne

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 70Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 70 years or older
  • Prospective fall risk of 40% or higher for the next year according to the Fall Risk Assessment Tool (FRAT-up)
  • Able to walk at least 70 meters in the 2 Minute Walk Test
  • Able to reach the study site at least by taxi
  • Provided written informed consent as required by guidelines and laws
Not Eligible

You will not qualify if you...

  • MoCA score below 10 points or MMSE below 17 points
  • Timed Up and Go test completed in less than 10 seconds
  • Leg amputation
  • Osteosynthesis or joint replacement of lower limbs within past 6 weeks
  • Blindness
  • Parkinson's disease with Hoehn and Yahr stage greater than 3
  • Body weight over 135 kg or height over 185 cm
  • Life expectancy under 12 months or unstable/severe illness
  • Inability to communicate verbally or cooperate appropriately
  • Previous participation in perturbation training programs
  • Gait-relevant foot-drop paresis

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Geriatric Center, Heidelberg University Hospital, Agaplesion Bethanien Krankenhaus

Heidelberg, Baden-Wurttemberg, Germany, 69126

Actively Recruiting

2

Department of Geriatric Medicine, University Hospital Marien Hospital Herne - Ruhr-University Bochum

Herne, North Rhine-Westphalia, Germany, 44625

Actively Recruiting

3

Carl von Ossietzky Universität, Department für Versorgungsforschung, Abteilung Geriatrie

Oldenburg, Germany, 26129

Actively Recruiting

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Research Team

T

Tania Prof. Dr. med. Zieschang

CONTACT

J

Jessica PD Dr. Koschate-Storm

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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