Fall Risk, Fall PreventionNCT04087512
Instrumented vs. Conventional Perturbation-based Balance Training for Fall Prevention
A study testing Training on perturbation treadmill and Exercises of dynamic stability under unstable conditions in people with Fall Risk, Fall Prevention, run by Leon Brüll at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall Risk, Fall Prevention
- What is being tested?
- Training on perturbation treadmill and Exercises of dynamic stability under unstable conditions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteGermany
- Study dates
- 23 Sep 2019to 23 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Severe cardiovascular or metabolic disorders
- Orthopaedic restrictions or diseases
- Strong dizziness
- Current chemotherapy
- Severe respiratory disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Fall Risk, Fall Prevention
- Being tested
- Training on perturbation treadmill, Exercises of dynamic stability under unstable conditions
- Keywords
- perturbation-based balance training, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training on perturbation treadmillOther
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 conditionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Instrumented perturbation-based balance training | Experimental | Not described Receives: Other: Training on perturbation treadmill |
| Conventional perturbation-based balance training | Experimental | Not described Receives: Other: Exercises of dynamic stability under unstable conditions |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance performance
Brief Balance Evaluation Systems Test (Brief-BESTest)
Measured: Change from baseline to post intervention test (an average of 7 weeks)
Secondary outcomes (10)
Neuromuscular control during perturbations
Muscle synergies derived by non-negative matrix factorization from surface electromyography on 13 leg muscles
Measured: Change from baseline to post intervention test (an average of 7 weeks)
Reactive balance performance
Step, stepping, fall-threshold test on Balance Tutor
Measured: Change from baseline to post intervention test (an average of 7 weeks)
Static balance performance
Center of pressure on force plate
Measured: Change from baseline to post intervention test (an average of 7 weeks)
Limits of stability
Limits of stability on force plate
Measured: Change from baseline to post intervention test (an average of 7 weeks)
Spatio-temporal gait parameters
GAITRite System
Measured: Change from baseline to post intervention test (an average of 7 weeks)
Functional leg strength (a)
30 s Chair rise test
Measured: Change from baseline to post intervention test (an average of 7 weeks)
Functional leg strength (b)
Timed Up-and-Go test
Measured: Change from baseline to post intervention test (an average of 7 weeks)
Force capacity of knee extensors
Isometric force test on force plate
Measured: 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
Measured: 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
Measured: Post intervention test (on average 7 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start23 Sep 2019
- Primary completion23 Oct 2020
- Study completion23 Oct 2020
Why it stopped: Due to sudden Corona pandemic related restrictions and an expiration of funding in case of further delay it was decided to prematurely terminate study recruitment and proceed evaluation with a smaller sample size than intended (n=71 instead n=111).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall Risk, Fall PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leon Brüll
- Sponsor type
- University, hospital or other
- Collaborators
- Humboldt-Universität zu Berlin
- Responsible party
- Sponsor-investigator, Leon Brüll, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087512
- Sponsor's protocol ID
- AZ Schwe 2019 /1-2
- Status last verified
- Sep 2022
- First submitted
- 6 Sep 2019
- Last updated
- 21 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of an Instrumented and a Conventional Perturbation-Based Balance Training for Preventing Falls in Older Persons
- ClinicalTrials.gov ID
- NCT04087512
- Acronym / sponsor ID
- AZ Schwe 2019 /1-2
- Conditions
- Fall Risk, Fall Prevention
- Keywords
- perturbation-based balance training, exercise
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to sudden Corona pandemic related restrictions and an expiration of funding in case of further delay it was decided to prematurely terminate study recruitment and proceed evaluation with a smaller sample size than intended (n=71 instead n=111).
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Leon BrüllUniversity, hospital or other
- Collaborators
- Humboldt-Universität zu Berlin
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training on perturbation treadmillPerturbations 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. | Other | Instrumented perturbation-based balance training |
| Exercises of dynamic stability under unstable conditionsThe 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. | Other | Conventional perturbation-based balance training |
Primary outcome
Balance performance
Time frame: Change from baseline to post intervention test (an average of 7 weeks)
Brief Balance Evaluation Systems Test (Brief-BESTest)
10 secondary outcomes
Neuromuscular control during perturbations
Time frame: Change from baseline to post intervention test (an average of 7 weeks)
Reactive balance performance
Time frame: Change from baseline to post intervention test (an average of 7 weeks)
Static balance performance
Time frame: Change from baseline to post intervention test (an average of 7 weeks)
Limits of stability
Time frame: Change from baseline to post intervention test (an average of 7 weeks)
Spatio-temporal gait parameters
Time frame: Change from baseline to post intervention test (an average of 7 weeks)
Functional leg strength (a)
Time frame: Change from baseline to post intervention test (an average of 7 weeks)
Functional leg strength (b)
Time frame: Change from baseline to post intervention test (an average of 7 weeks)
Force capacity of knee extensors
Time frame: Change from baseline to post intervention test (an average of 7 weeks)
Fear of falling
Time frame: Change from baseline to post intervention test (an average of 7 weeks)
Feasibility of training paradigms
Time frame: Post intervention test (on average 7 weeks after baseline)
Results and safety
The study was stopped early (reason given: Due to sudden Corona pandemic related restrictions and an expiration of funding in case of further delay it was decided to prematurely terminate study recruitment and proceed evaluation with a smaller sample size than intended (n=71 instead n=111).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training on perturbation treadmill and Exercises of dynamic stability under unstable conditions in people with Fall Risk, Fall Prevention, run by Leon Brüll at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to sudden Corona pandemic related restrictions and an expiration of funding in case of further delay it was decided to prematurely terminate study recruitment and proceed evaluation with a smaller sample size than intended (n=71 instead n=111).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance performance (time frame: Change from baseline to post intervention test (an average of 7 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.