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Instrumented vs. Conventional Perturbation-based Balance Training for Fall Prevention

Comparison of an Instrumented and a Conventional Perturbation-Based Balance Training for Preventing Falls in Older Persons

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04087512
Enrollment
71
Registered
2019-09-12
Start date
2019-09-23
Completion date
2020-10-23
Last updated
2022-09-21

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

Conditions

Fall Risk, Fall Prevention

Keywords

perturbation-based balance training, exercise

Brief summary

In the past years, several studies have demonstrated the potential of task-specific perturbation-based balance training (PBT) for preventing falls at age. However, different paradigms of PBT have been investigated so far, while a comparison of these paradigms is lacking. Therefore, in this study, we plan to compare two promising PBT approaches in terms of feasibility and effects on fall risk-associated motor performance: 1. Training of dynamic stability mechanisms in the presence of perturbations induced by unstable surfaces; 2. Technology-supported training on a perturbation treadmill. In addition, both approaches will be compared with a passive control group. One-hundred and eleven participants aged 65 years or older will be randomly assigned to the three arms of the study. As the primary outcome, we will assess fall risk by use of the Brief-BESTest. Secondary outcomes include balance performance, functional performance, force capacity, and more. We hypothesize that both interventions will lead to a significant reduction of fall risk compared to the control group. Additionally, we will explore whether one of the two PBT paradigms is superior regarding feasibility and effectiveness.

Interventions

OTHERTraining on perturbation treadmill

Perturbations into different directions are induced during static and dynamic tasks on a treadmill. Perturbations include announced and unannounced perturbations. Intensity and number of perturbations increases over the course of the intervention based on judgement of participant. Intervention duration: 6 weeks, 3 sessions a week, each session approx. 30 minutes.

OTHERExercises of dynamic stability under unstable conditions

The mechanisms of dynamic stability recovery are trained under unstable conditions. Different unstable undergrounds are used to stand on, perform lunges or jumps. Additionally, balance is challenged by different restrictions (e.g. decreased base of support, closed eyes) or therapist-applied perturbations. Intervention duration: 6 weeks, 3 sessions a week, each session approx. 45 minutes.

Sponsors

Humboldt-Universität zu Berlin
CollaboratorOTHER
Leon Brüll
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Assessors are blinded during baseline-assessment.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Aged 65 years or older * Speaks German language * Home-dwelling or assisted living * One fall in the past 12 months OR a verified fall risk (based on subjective decreased balance AND extended Short Physical Performance Battery (SPPB) balance testing * Able to walk at least 20 minutes without aid * Available for intervention period

Exclusion criteria

* Participation in balance training in the previous 3 months * DemTec ≤ 8 Points * Body mass index \> 30 * Uncorrected vision disorder * Acute serious neurological disability affecting gait pattern * Serious sensory disorders * Severe cardiovascular or metabolic disorders * Orthopaedic restrictions or diseases * Strong dizziness * Current chemotherapy * Severe respiratory disease

Design outcomes

Primary

MeasureTime frameDescription
Balance performanceChange from baseline to post intervention test (an average of 7 weeks)Brief Balance Evaluation Systems Test (Brief-BESTest)

Secondary

MeasureTime frameDescription
Reactive balance performanceChange from baseline to post intervention test (an average of 7 weeks)Step, stepping, fall-threshold test on Balance Tutor
Static balance performanceChange from baseline to post intervention test (an average of 7 weeks)Center of pressure on force plate
Limits of stabilityChange from baseline to post intervention test (an average of 7 weeks)Limits of stability on force plate
Spatio-temporal gait parametersChange from baseline to post intervention test (an average of 7 weeks)GAITRite System
Neuromuscular control during perturbationsChange from baseline to post intervention test (an average of 7 weeks)Muscle synergies derived by non-negative matrix factorization from surface electromyography on 13 leg muscles
Functional leg strength (b)Change from baseline to post intervention test (an average of 7 weeks)Timed Up-and-Go test
Force capacity of knee extensorsChange from baseline to post intervention test (an average of 7 weeks)Isometric force test on force plate
Fear of fallingChange from baseline to post intervention test (an average of 7 weeks)Short Falls Efficacy Scale-International (Short FES-I); range: 7-28 points, high value indicates high fear of falling
Feasibility of training paradigmsPost intervention test (on average 7 weeks after baseline)Acceptance of training questionnaire; range: 1-6 points, high value indicates high acceptance
Functional leg strength (a)Change from baseline to post intervention test (an average of 7 weeks)30 s Chair rise test

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026