- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02836587
The Influence of Balance Training on Postural Control in Elderly
September 19, 2017 updated by: Zdenek Svoboda, Palacky University
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 Overview
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Olomouc, Czechia, 77111
- Faculty of Physical Culture, Palacky University Olomouc
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: interventional
Experimental group will undergo balance training for 8 weeks.
|
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.
|
No Intervention: control
Control group will have no assigned intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline Berg balance scale score after completing intervention
Time Frame: 2 months
|
2 months
|
Change from baseline mean velocity of centre of pressure during quiet stance after completing intervention
Time Frame: 2 months
|
2 months
|
Change from baseline stride time variability after completing intervention
Time Frame: 2 months
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline Falls efficacy scale - International score after completing intervention
Time Frame: 2 months
|
2 months
|
Change from baseline gait velocity after completing intervention
Time Frame: 2 months
|
2 months
|
Change from baseline short-term Lyapunov exponents after completing intervention
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zdenek Svoboda, Ph.D., Faculty of Physical Culture, Palacky University Olomouc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Actual)
July 16, 2017
Study Completion (Actual)
September 19, 2017
Study Registration Dates
First Submitted
June 7, 2016
First Submitted That Met QC Criteria
July 14, 2016
First Posted (Estimate)
July 19, 2016
Study Record Updates
Last Update Posted (Actual)
September 20, 2017
Last Update Submitted That Met QC Criteria
September 19, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- UPOL_FTK_001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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