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

Not Applicable

Terminated

• Conditions: Fall Risk, Fall Prevention
• Interventions: Other: Training on perturbation treadmill; Other: Exercises of dynamic stability under unstable conditions

• Registration Number: NCT04087512
• Lead Sponsor: Leon Brüll

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-06
• Study First Submitted QC: 2019-09-11
• Study First Posted: 2019-09-12
• Study Start: 2019-09-23
• Primary Completion: 2020-10-23
• Study Completion: 2020-10-23
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-18
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Instrumented perturbation-based balance training	Training on perturbation treadmill	-
Conventional perturbation-based balance training	Exercises of dynamic stability under unstable conditions	-

Primary Outcome Measures

Name	Time	Method
Balance performance	Change from baseline to post intervention test (an average of 7 weeks)	Brief Balance Evaluation Systems Test (Brief-BESTest)

Secondary Outcome Measures

Name	Time	Method
Reactive balance performance	Change from baseline to post intervention test (an average of 7 weeks)	Step, stepping, fall-threshold test on Balance Tutor
Limits of stability	Change from baseline to post intervention test (an average of 7 weeks)	Limits of stability on force plate
Neuromuscular control during perturbations	Change 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
Spatio-temporal gait parameters	Change from baseline to post intervention test (an average of 7 weeks)	GAITRite System
Functional leg strength (a)	Change from baseline to post intervention test (an average of 7 weeks)	30 s Chair rise test
Functional leg strength (b)	Change from baseline to post intervention test (an average of 7 weeks)	Timed Up-and-Go test
Static balance performance	Change from baseline to post intervention test (an average of 7 weeks)	Center of pressure on force plate
Feasibility of training paradigms	Post intervention test (on average 7 weeks after baseline)	Acceptance of training questionnaire; range: 1-6 points, high value indicates high acceptance
Force capacity of knee extensors	Change from baseline to post intervention test (an average of 7 weeks)	Isometric force test on force plate
Fear of falling	Change 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

Trial Locations

Locations (1)

Heidelberg University, Network Aging Research; 🇩🇪 Heidelberg, Germany