Accidental FallsNCT02836587
The Influence of Balance Training on Postural Control in Elderly
A study testing Balance training in people with Accidental Falls, run by Palacky University at 1 site in Czechia.
Trial summary
Fall related injuries are major health problem which effect especially elderly population. After experiencing a fall, most of the elderly are unable to resume their previous mobility and the fear of future falls affects their daily life. Falls in elderly population are often related to balance or gait problems. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Balance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCzechia
- Study dates
- Sep 2016to 19 Sep 2017
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 60+
- ability to stand and walk without aid or support
- participation in the institutional program "Falls risk and balance assessment" with successful completion of one year of observation for falls
Who cannot join
- neuromuscular or orthopaedic impairments that severely limit mobility and balance
- surgery or injury on the musculoskeletal system less than 2 years before baseline measurement
- any acute illness
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Faculty of Physical Culture, Palacky University Olomouc
Olomouc, 77111
About this study
Fall related injuries are major health problem which effect especially elderly population. After experiencing a fall, most of the elderly are unable to resume their previous mobility and the fear of future falls affects their daily life. Falls in elderly population are often related to balance or gait problems. The aim of this study is to assess the influence of balance training on postural and motor control of healthy elderly participants. The study is designed as a parallel interventional study with experimental and control group (allocation ratio 1:1). Participants' general health, balance abilities, fear of falling and gait stability and variability will be assessed on the baseline measurement, right after and 2 months after the completion of the training programme. Experimental group will undergo training focused on development of balance abilities and strength twice a week (60 minutes in length each) for 8 weeks. Participants will receive individualized exercises which will be focused on the main 4 types - stance exercises, gait and transition exercises and strength exercises especially focused on muscle strength of lower extremities.
- Conditions
- Accidental Falls
- Being tested
- Balance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance trainingBehavioural
The interventional program will last 8 weeks with the intensity of two 60-minutes lectures a week. Training sessions will be delivered by a physiotherapist to small groups of patients (3-5). Participants will receive individualized exercises which will be focused on main 4 types - stance exercises, gait and transition exercises and strength exercises especially focused on muscle strength of the lower extremities. The difficulty level will be increased progressively after participant's ability to complete each exercise independently (e.g. eyes closed, exercises on balance equipment - wobble board, foam etc., addition of a secondary cognitive task). The training session will consist of a ten-minute warm-up followed by five-minute stretching, 30 minutes of balance training and 15 minutes of stretching and relaxation.
| Study group | Role | What they receive |
|---|---|---|
| interventional | Experimental | Experimental group will undergo balance training for 8 weeks. Receives: Behavioral: Balance training |
| control | No intervention | Control group will have no assigned intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Berg balance scale score after completing intervention
Measured: 2 months
Change from baseline mean velocity of centre of pressure during quiet stance after completing intervention
Measured: 2 months
Change from baseline stride time variability after completing intervention
Measured: 2 months
Secondary outcomes (3)
Change from baseline Falls efficacy scale - International score after completing intervention
Measured: 2 months
Change from baseline gait velocity after completing intervention
Measured: 2 months
Change from baseline short-term Lyapunov exponents after completing intervention
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startSep 2016
- Primary completion16 Jul 2017
- Study completion19 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies 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
- Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palacky University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zdenek Svoboda, Palacky University
- Investigators
- Zdenek Svoboda, Ph.D., Principal investigator, Faculty of Physical Culture, Palacky University Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836587
- Sponsor's protocol ID
- UPOL_FTK_001
- Status last verified
- Sep 2017
- First submitted
- 7 Jun 2016
- Last updated
- 20 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Balance Training on Postural Control in Elderly
- ClinicalTrials.gov ID
- NCT02836587
- Acronym / sponsor ID
- UPOL_FTK_001
- Conditions
- Accidental Falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Palacky UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 16 Jul 2017 (actual)
- Study completion
- 19 Sep 2017 (actual)
- First posted
- 19 Jul 2016 (estimated)
- 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.
Fall related injuries are major health problem which effect especially elderly population. After experiencing a fall, most of the elderly are unable to resume their previous mobility and the fear of future falls affects their daily life. Falls in elderly population are often related to balance or gait problems. The aim of this study is to assess the influence of balance training on postural and motor control of healthy elderly participants. The study is designed as a parallel interventional study with experimental and control group (allocation ratio 1:1). Participants' general health, balance abilities, fear of falling and gait stability and variability will be assessed on the baseline measurement, right after and 2 months after the completion of the training programme. Experimental group will undergo training focused on development of balance abilities and strength twice a week (60 minutes in length each) for 8 weeks. Participants will receive individualized exercises which will be focused on the main 4 types - stance exercises, gait and transition exercises and strength exercises especially focused on muscle strength of lower extremities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional | Experimental | Behavioral: Balance trainingExperimental group will undergo balance training for 8 weeks. |
| control | No intervention | –Control group will have no assigned intervention. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 60+
- ability to stand and walk without aid or support
- participation in the institutional program "Falls risk and balance assessment" with successful completion of one year of observation for falls
Key exclusion criteria (3 listed)
- neuromuscular or orthopaedic impairments that severely limit mobility and balance
- surgery or injury on the musculoskeletal system less than 2 years before baseline measurement
- any acute illness
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 |
|---|---|---|
| Balance trainingThe interventional program will last 8 weeks with the intensity of two 60-minutes lectures a week. Training sessions will be delivered by a physiotherapist to small groups of patients (3-5). Participants will receive individualized exercises which will be focused on main 4 types - stance exercises, gait and transition exercises and strength exercises especially focused on muscle strength of the lower extremities. The difficulty level will be increased progressively after participant's ability to complete each exercise independently (e.g. eyes closed, exercises on balance equipment - wobble board, foam etc., addition of a secondary cognitive task). The training session will consist of a ten-minute warm-up followed by five-minute stretching, 30 minutes of balance training and 15 minutes of stretching and relaxation. | Behavioural | interventional |
Primary outcome
Change from baseline Berg balance scale score after completing intervention
Time frame: 2 months
Change from baseline mean velocity of centre of pressure during quiet stance after completing intervention
Time frame: 2 months
Change from baseline stride time variability after completing intervention
Time frame: 2 months
3 secondary outcomes
Change from baseline Falls efficacy scale - International score after completing intervention
Time frame: 2 months
Change from baseline gait velocity after completing intervention
Time frame: 2 months
Change from baseline short-term Lyapunov exponents after completing intervention
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
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Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
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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.
Zdenek Svoboda, Ph.D. principal investigator
Faculty of Physical Culture, Palacky University Olomouc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance training in people with Accidental Falls, run by Palacky University at 1 site in Czechia.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 20 Sep 2017. 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 Czechia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline Berg balance scale score after completing intervention (time frame: 2 months). The study lists 3 primary outcomes in all. 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 20 Sep 2017.