Perturbation-Based Treadmill Training to Prevent Unrecovered Falls in Geriatric Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorUniversity of Oldenburg
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
≥ 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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Conventional Treadmill Walking (CTT)
Other interventionThe 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)
Other interventionOverall, 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.
Treatment groups
396 Participants
are divided into 2 treatment groupsGroup A: Conventional Treadmill Training (CTT)Active comparator 1 intervention
Group B: Perturbation-Based Balance Training (PBT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of unrecovered falls
Falls are assessed using fall calendars, telephone interviews, and proxy information.
Time frame
Continuously from intervention end until 12 months after the end of the interventionSecondary outcomes
1
Rate of falls
Falls are assessed using fall calenders, telephone interviews, and proxy information.
Time frame
Continuously from intervention end until 12 months after the end of the intervention2
Physical activity
Physical activity will be measured over 7 days using a body-fixed inertial measurement unit (AX6, Axivity Ltd., Newcastle, UK) , which will be placed at lumbar level (L5) of the participant. The sensor measures linear acceleration data in 3 dimensions in combination with angular data. From these data, besides others, time spent with physical activity, steps as well as time spent in the supine sitting or standing position can be determined and reported. Data will be used to describe the participants and to report falls per physical activity.
Time frame
Before the training intervention (up to 4 weeks before the beginning of the training), after the intervention (up to 8 weeks after its beginning), 6 months after the intervention, and 12 months after the intervention3
Stepping response (a)
Modified Stepping Threshold Tests (i.e. single step, multiple step threshold). Participants will experience suface perturbations in ante-posterior as well as mediolateral direction with increasing intensity until they have to perform a single compensatory step or multiple steps to recover balance. Higher perturbation levels for the single or multiple step threshold indicate better static reactive balance.
Time frame
12 months after the intervention4
Stepping reponse (b)
Choice Stepping Reaction Test
Time frame
Before the training intervention (up to 4 weeks before the beginning of the training), after the intervention (up to 8 weeks after its beginning), 6 months after the intervention, and 12 months after the interventionOther outcomes
1
Assessment of safety
Intervention-related adverse events
Time frame
Continuously from baseline assessment until 12 months after the end of the intervention (intervention starts at maximum 4 weeks after baseline assessment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Oldenburg
Lead sponsor
Marienhospital Herne
Collaborator
University of Ulm
Collaborator
University of Konstanz
Collaborator
University Hospital, Aachen
Collaborator
Robert Bosch-Krankenhaus Stuttgart
Collaborator
University Hospital Heidelberg
Collaborator
Technische Hochschule Ulm
Collaborator
Source ClinicalTrials.gov