Comparison of an Instrumented and a Conventional Perturbation-Based Balance Training for Preventing Falls in Older Persons
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- Balance performance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
Assessors are blinded during baseline-assessment.
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Control
Instrumented perturbation-based balance training
Intervention: Training on perturbation treadmill (Other)
Conventional perturbation-based balance training
Intervention: Exercises of dynamic stability under unstable conditions (Other)
Outcomes
Primary Outcomes
Balance performance
Time Frame: Change from baseline to post intervention test (an average of 7 weeks)
Brief Balance Evaluation Systems Test (Brief-BESTest)
Secondary Outcomes
- Limits of stability(Change from baseline to post intervention test (an average of 7 weeks))
- Reactive balance performance(Change from baseline to post intervention test (an average of 7 weeks))
- Neuromuscular control during perturbations(Change from baseline to post intervention test (an average of 7 weeks))
- Spatio-temporal gait parameters(Change from baseline to post intervention test (an average of 7 weeks))
- Functional leg strength (a)(Change from baseline to post intervention test (an average of 7 weeks))
- Functional leg strength (b)(Change from baseline to post intervention test (an average of 7 weeks))
- Static balance performance(Change from baseline to post intervention test (an average of 7 weeks))
- Feasibility of training paradigms(Post intervention test (on average 7 weeks after baseline))
- Force capacity of knee extensors(Change from baseline to post intervention test (an average of 7 weeks))
- Fear of falling(Change from baseline to post intervention test (an average of 7 weeks))
Investigators
Leon Brüll
M.A.
Heidelberg University