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

NCT04087512 | Terminated

• 1 other identifier: AZ Schwe 2019 /1-2
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Fall Risk, Fall Prevention

Keywords

perturbation-based balance training; exercise

Outcome Measures

Primary Outcomes (1)

• Balance performance

  Brief Balance Evaluation Systems Test (Brief-BESTest)

  Change from baseline to post intervention test (an average of 7 weeks)

Secondary Outcomes (10)

• Neuromuscular control during perturbations

  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)

• Static balance performance

  Change from baseline to post intervention test (an average of 7 weeks)

• Limits of stability

  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)

Study Arms (3)

Instrumented perturbation-based balance training

EXPERIMENTAL

Other: Training on perturbation treadmill

Conventional perturbation-based balance training

EXPERIMENTAL

Other: Exercises of dynamic stability under unstable conditions

Control

NO INTERVENTION

Interventions

Training on perturbation treadmill OTHER

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.

Instrumented perturbation-based balance training

Exercises of dynamic stability under unstable conditions OTHER

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.

Conventional perturbation-based balance training

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Leon Brüll: lead
• Humboldt-Universität zu Berlin: collaborator

Study Sites (1)

Heidelberg University, Network Aging Research

Heidelberg, 69115, Germany

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors are blinded during baseline-assessment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.A.

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 12, 2019
• Study Start: September 23, 2019
• Primary Completion: October 23, 2020
• Study Completion: October 23, 2020
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

DE (1)