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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00037929
Enrollment
396
Registered
2025-11-06
Start date
2024-10-29
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unrecovered falls in older people

Interventions

Group 1: Intervention group: Training on a treadmill with perturbations Group 2: Control group: Conventional treadmill training (PBT)

Sponsors

Universität Oldenburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
70 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Individuals with an estimated risk of falling of = 40% for the following year according to the Fall Risk Assessment Tool (FRAT-up) 2. Men or women aged = 70 years 3. Walking distance =70 m in the 2MWT without walking aid 4. Written informed consent obtained according to international guidelines and local laws 5. Ability to understand the nature of the study and the study related procedures and to comply with them 6. Possibility to reach the study site at least via taxi

Exclusion criteria

Exclusion criteria: 1. MoCA score 3 5. Osteosynthesis or joint replacement of lower extremities within the past 6 weeks 6. Body weight =135 kg and height =185 cm according to the technical and safety requirements of the perturbation treadmill 7. Life-expectancy <12 months, instable or severe illness 8. Prior perturbation training 9. Gait-relevant foot-drop paresis

Design outcomes

Primary

MeasureTime frame
The rate of unrecovered falls over the 12-month follow-up period (unrecovered falls per person-year)

Secondary

MeasureTime frame
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 intervention. 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 intervention. 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 intervention. Time frame of the following secondary outcomes: 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 intervention. Stepping reponse (b): Choice Stepping Reaction Test. Cognitive functioning (a): Montreal Cognitive Assessment (MoCA). Minimum value: 0 points; Maximum value: 30 points; higher values indicate better cognitive functioning. Cognitive functioning (b)

Countries

Germany

Contacts

Public ContactTania Zieschang

Universität Oldenburg

tania.zieschang@uni-oldenburg.de+49441 403-3351

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026