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

Study Overview
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Brief Summary
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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.

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

Conditions
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Fall Risk, Fall Prevention

Intervention / Treatment
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* Other: Training on perturbation treadmill
* Other: Exercises of dynamic stability under unstable conditions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Instrumented perturbation-based balance training<br> | Other: Training on perturbation treadmill<br>* 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.<br>|
| Experimental: Conventional perturbation-based balance training<br> | Other: Exercises of dynamic stability under unstable conditions<br>* 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.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance performance | Brief Balance Evaluation Systems Test (Brief-BESTest) | Change from baseline to post intervention test (an average of 7 weeks) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perturbation-based balance training, exercise