Perturbation-Based Treadmill Training to Prevent Unrecovered Falls in Geriatric Patients
Training at the Limit of Balance Control on a Perturbation Treadmill to Prevent Unrecovered Falls in Geriatric Patients With and Without Cognitive Impairment
University of Oldenburg
396 participants
Nov 25, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- ≥ 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 Criteria11
- 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
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Interventions
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.
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.
Locations(3)
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NCT06652828