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

NCT ID: NCT04087512

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-23
• Study Completion Date: 2020-10-23

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Instrumented perturbation-based balance training

Group Type: EXPERIMENTAL

Training on perturbation treadmill

Intervention Type: 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.

Conventional perturbation-based balance training

Group Type: EXPERIMENTAL

Exercises of dynamic stability under unstable conditions

Intervention Type: 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.

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Humboldt-Universität zu Berlin

OTHER

Sponsor Role: collaborator

Leon Brüll

OTHER

Sponsor Role: lead

Responsible Party

Leon Brüll

M.A.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Heidelberg University, Network Aging Research

Heidelberg, , Germany

Countries

Germany

Other Identifiers

AZ Schwe 2019 /1-2

Identifier Type: -

Identifier Source: org_study_id