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Fall PreventionTRAILNCT06652828

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

A study testing Conventional Treadmill Walking (CTT) and Perturbation-Based Balance Training (PBT) in people with Fall Prevention and Exercise, run by University of Oldenburg at 3 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Fall Prevention, Exercise, Geriatrics
What is being tested?
Conventional Treadmill Walking (CTT) and Perturbation-Based Balance Training (PBT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
396 participants
Where
3 sitesGermany
Study dates
25 Nov 2024to 30 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • ≥ 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Tania Prof. Dr. med. Zieschang contact

+49 441 798-4760

tania.zieschang@uol.de

Jessica PD Dr. Koschate-Storm contact

+49 441 798-4760

jessica.koschate-storm@uol.de

Germany3 sites, 3 recruiting
  • Geriatric Center, Heidelberg University Hospital, Agaplesion Bethanien Krankenhaus

    Heidelberg, Baden-Wurttemberg, 69126

    Clemens Becker, Prof. Dr., 496221-319-1759, Clemens.becker@rbk.de

    Christian Werner, Dr., +496221-319-1759, christian.werner@med.uni-heidelberg.de

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

    Herne, North Rhine-Westphalia, 44625

    Rainer Wirth, Prof. Dr. med., +49 2323 - 499 - 3387, Rainer.wirth@elisabethgruppe.de

    Ulrike Trampisch, Dr., +49 2323 - 499 - 3387, Ulrike.Trampisch@elisabethgruppe.de

    Recruiting
  • Carl von Ossietzky Universität, Department für Versorgungsforschung, Abteilung Geriatrie

    Oldenburg, 26129

    Tania Zieschang, Prof. Dr. med., +49 441 798-4760, tania.zieschang@uol.de

    Jessica Koschate-Storm, PD Dr., +49 441 798-4760, jessica.koschate-storm@uol.de

    Recruiting

Other trials in Germany

About this study

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

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.

Read the detailed description

Falls are common and the leading cause of injuries among older adults, but falls may be attenuated by the promising and time-efficient intervention called perturbation-based balance training (PBT). The aim of the TRAIL-study is to confirm the effectiveness of a treadmill PBT protocol for preventing unrecovered falls in geriatric patients with and without cognitive impairment. This study is designed as a confirmatory, multicenter, assessor-blinded, randomized controlled study. The 396 geriatric patients aged ≥70 years with ≥40% prospective fall risk and being capable of walking ≥70 m in a 2-Minute Walk Test will receive 9 sessions of PBT on a treadmill (intervention) or a conventional treadmill training (control group; CTT).

Outcome assessments will be performed shortly after the intervention interval as well as 6 and 12 months thereafter. The primary outcome is defined as unrecovered falls (defined as falls in which persons who fell are unable to get up independently) within 12-month follow-up. Falls are documented over at least 12 months using calendars, telephone interviews, and proxy information. Secondary outcomes include mobility, balance performance, concerns about falling, physical activity and capacity, stepping responses, health-related quality of life, cognitive functioning, mobility, reactive dynamic balance and training acceptability of PBT. The study will be accompanied by a patient advisory board and an expert advisory board and focus groups will be conducted to involve the target group.

Based on pilot studies and the available literature, we expect a ≥50% reduction of unrecovered falls during the following year in the intervention group (PBT) compared to the control group (CTT).

Being tested
Conventional Treadmill Walking (CTT), Perturbation-Based Balance Training (PBT)
Keywords
treadmill, unrecovered falls, fall risk, training, falls, balance, rehabilitaion
Medical subject headings
Motor Activity, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional Treadmill Walking (CTT)Other

    Also called Exercise intervention

    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.

  • Perturbation-Based Balance Training (PBT)Other

    Also called Gait adaptability training, Reactive balance training

    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.

Study groups in NCT06652828
Study groupRoleWhat they receive
Conventional Treadmill Training (CTT)Active comparatorNot described
Receives: Other: Conventional Treadmill Walking (CTT)
Perturbation-Based Balance Training (PBT)ExperimentalNot described
Receives: Other: Perturbation-Based Balance Training (PBT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of unrecovered falls

    Falls are assessed using fall calendars, telephone interviews, and proxy information.

    Measured: Continuously from intervention end until 12 months after the end of the intervention

Secondary outcomes (17)
  1. Rate of falls

    Falls are assessed using fall calenders, telephone interviews, and proxy information.

    Measured: Continuously from intervention end until 12 months after the end of the intervention

  2. 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.

    Measured: 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

  3. 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.

    Measured: 12 months after the intervention

  4. Stepping reponse (b)

    Choice Stepping Reaction Test

    Measured: 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

  5. Cognitive functioning (a)

    Montreal Cognitive Assessment (MoCA). Minimum value: 0 points; Maximum value: 30 points; higher values indicate better cognitive functioning.

    Measured: Before the training intervention (up to 4 weeks before the beginning of the training), and 12 months after the intervention

  6. Cognitive functioning (b)

    TMT (Trail Making Test)

    Measured: 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

  7. Concerns about falling

    Short Falls Efficacy Scale International (Short FES-I). Minimum value: 7 points, Maximum value: 28 points; higher values indicate more concerns about falling.

    Measured: 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

  8. Health-related quality of life

    Euro Quality of Life with visual analogue scales (EQ-VAS), values of 0-100: lower values indicate worse subjective health; EuroQol 5-Dimensions 5-Levels

    Measured: 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

  9. Physical capacity (a)

    2MWT (2 Minute Walk Test )

    Measured: 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

  10. Physical capacity (b)

    SPPB (Short Physical Performance Battery), including balance, leg strength and gait speed; minimum value: 0 points; maximum value: 12 points; higher values indicate better physical capacity.

    Measured: 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

  11. Physical capacity (c)

    TUG (Timed "Up and Go"-Test)

    Measured: 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

  12. Nutritional status

    MNA (Mini Nutritional Assessment); values of 0-30: lower values indicate worse nutritional status

    Measured: Before the training intervention (up to 4 weeks before the beginning of the training), 6 months after the intervention, and 12 months after the intervention

  13. Reactive dynamic balance (a)

    Adapted Compensatory Arm and Leg Movements after perturbations induced on the treadmill during walking. Minimum value: 16 points; Maximum value: 108 points; higher values indicate better reactive dynamic balance.

    Measured: 3rd (during the on average 1st week of the intervention) and last training session (during the on average 3rd week, at maximum 6th week of the intervention) (intervention group only), and 12 months after the intervention (intervention and control group)

  14. Reactive dynamic balance (b)

    Spatio-temporal, kinematic and stability parameters (video-based, inertial measurement units and center of pressure data)

    Measured: 3rd (during the on average 1st week of the intervention) and last training session (during the on average 3rd week, at maximum 6th week of the intervention) (intervention group only), and 12 months after the intervention (intervention and control group)

  15. Laboratory falls

    Falls after perturbations on the treadmill. A fall is determined based on video recordings. A fall is defined as unambiguous support by the safety harness after the perturbation.

    Measured: during 3rd (on average 1st week of the intervention) and last training session (on average 3rd week, at maximum 6th week of the intervention; intervention group only), and 12 months after the intervention (intervention and control group)

  16. Acceptability of PBT

    Theoretical Framework of Acceptability-based Questionnaire

    Measured: during the last training session (during the on average 3rd week, at maximum 6th week of the intervention, in the intervention group only)

  17. Vibration sensation

    Vibration measurement at the inner ankle using a tuning fork. Minimum value: 1 point, Maximum value: 8 points; higher values indicate higher sensation

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2024
  2. Study start25 Nov 2024
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
396 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06652828
Sponsor's protocol ID
2022-UOL-MG-005-01
Other IDs
01KG2303
Acronym
TRAIL
Status last verified
May 2025
First submitted
17 Oct 2024
Last updated
14 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be made available upon reasonable request via e-mail.

Publications

  • Koschate-Storm J, Werner C, Bartel J, Bauer JM, Becker C, Drefs S, El-Seoud N, Giehl C, Hackbarth M, Hezel N, Klenk J, Trampisch U, Wirth R, Zieschang T, Schwenk M. 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. BMC Geriatr. 2025 Dec 23;26(1):143. doi: 10.1186/s12877-025-06599-w.

    PubMed 41436967

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Treadmill Walking (CTT) and Perturbation-Based Balance Training (PBT) in people with Fall Prevention and Exercise, run by University of Oldenburg at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tania Prof. Dr. med. Zieschang (+49 441 798-4760, tania.zieschang@uol.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of unrecovered falls (time frame: Continuously from intervention end until 12 months after the end of the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06652828, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.

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