Actively Recruiting

Phase Not Applicable
Age: 70Years +
All Genders
ID06652828

Training at the Limit of Balance Control on a Perturbation Treadmill to Prevent Unrecovered Falls in Geriatric Patients With and Without Cognitive Impairment

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

396

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Oldenburg

Lead Sponsor

M

Marienhospital Herne

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how well perturbation-based balance training (PBT) works to prevent unrecovered falls in older adults aged 70 years and above who have at least a 40% risk of falling within a year. This study also evaluates the safety and feasibility of PBT. It is a confirmatory, multicenter, assessor-blinded, randomized controlled trial that includes patients with and without cognitive impairment. The primary focus is on reducing falls where individuals cannot get up independently, with a total of 396 participants enrolled. Participants will receive nine training sessions over 3 to 6 weeks. They are randomly assigned to either the PBT group, which practices balance training on a treadmill with varying perturbations, or a control group receiving conventional treadmill walking without perturbations. Both groups train with safety harnesses and matched exercise times to ensure consistency. Assessments occur before and after the intervention phase. Throughout the study, participants will be monitored for falls using calendars, phone interviews, and proxy reports for up to 12 months after training ends. Additional evaluations include mobility, balance, concerns about falling, physical activity, cognitive function, quality of life, stepping responses, and nutritional status. Follow-up assessments are conducted at 6 and 12 months after the intervention to measure outcomes and training acceptability. The entire study spans over a year, with continuous safety and progress monitoring.

CONDITIONS

Brief 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 following year according to the Fall Risk Assessment Tool (FRAT-up)
  • Ability to walk at least 70 meters in the 2 Minute Walk Test
  • Ability to reach the study site at least by taxi
  • Written informed consent according to guidelines and laws
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 to 6 weeks

Participants receive 9 sessions of treadmill training over 3 to 6 weeks, either perturbation-based balance training (PBT) or conventional treadmill walking (CTT). Safety harnesses are used during all sessions.

9 training sessions

Follow-up

Duration - 12 months

Participants are monitored for unrecovered falls and other health outcomes for 12 months after the end of the treadmill training intervention.

Regular assessments including fall documentation via calendars, telephone interviews, and proxy information

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 Universitรคt, Department fรผr Versorgungsforschung, Abteilung Geriatrie

Oldenburg, Germany, 26129

Actively Recruiting

Loading map...

Research Team

T

Tania Prof. Dr. med. Zieschang

J

Jessica PD Dr. Koschate-Storm

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Similar Trials

The SPARK Trial: A Digital Exercise Intervention for Patient...

Spondyloarthritis

Actively Recruiting

1 location

A Digital Life Story to Support Person-centred Care for Olde...

Cognitive Impairment

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Treadmill perturbation-based balance training to prevent unrecovered falls in fall-prone older adults with and without cognitive impairment: protocol for the multi-center randomized controlled TRAIL study.

J Koschate-Storm, C Werner, J Bartel...

https://pubmed.ncbi.nlm.nih.gov/41436967