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

Fall Risk, Fall Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04087512
• Other study ID #: AZ Schwe 2019 /1-2
• Status: Terminated
• Phase: N/A
• Start date: September 23, 2019
• Est. completion date: October 23, 2020

Study information

• Verified date: September 2022
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 71
• Est. completion date: October 23, 2020
• Est. primary completion date: October 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fall Risk, Fall Prevention

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Heidelberg University, Network Aging Research	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
Leon Brüll	Humboldt-Universität zu Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Balance performance	Brief Balance Evaluation Systems Test (Brief-BESTest)	Change from baseline to post intervention test (an average of 7 weeks)
Secondary	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)
Secondary	Reactive balance performance	Step, stepping, fall-threshold test on Balance Tutor	Change from baseline to post intervention test (an average of 7 weeks)
Secondary	Static balance performance	Center of pressure on force plate	Change from baseline to post intervention test (an average of 7 weeks)
Secondary	Limits of stability	Limits of stability on force plate	Change from baseline to post intervention test (an average of 7 weeks)
Secondary	Spatio-temporal gait parameters	GAITRite System	Change from baseline to post intervention test (an average of 7 weeks)
Secondary	Functional leg strength (a)	30 s Chair rise test	Change from baseline to post intervention test (an average of 7 weeks)
Secondary	Functional leg strength (b)	Timed Up-and-Go test	Change from baseline to post intervention test (an average of 7 weeks)
Secondary	Force capacity of knee extensors	Isometric force test on force plate	Change from baseline to post intervention test (an average of 7 weeks)
Secondary	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)
Secondary	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)