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

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 Overview

• Status: Terminated
• Conditions: Fall Risk, Fall Prevention
• Intervention / Treatment: Other: Training on perturbation treadmill; Other: Exercises of dynamic stability under unstable conditions

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69115
    • Heidelberg University, Network Aging Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Instrumented perturbation-based balance training	Other: Training 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.
Experimental: Conventional perturbation-based balance training	Other: Exercises 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Leon Brüll
• Collaborators: Humboldt-Universität zu Berlin

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2019
• Primary Completion (Actual): October 23, 2020
• Study Completion (Actual): October 23, 2020

Study Registration Dates

• First Submitted: September 6, 2019
• First Submitted That Met QC Criteria: September 11, 2019
• First Posted (Actual): September 12, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 18, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: exercise; perturbation-based balance training
• Other Study ID Numbers: AZ Schwe 2019 /1-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No