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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02836587
Other study ID # UPOL_FTK_001
Secondary ID
Status Completed
Phase N/A
First received June 7, 2016
Last updated September 19, 2017
Start date September 2016
Est. completion date September 19, 2017

Study information

Verified date September 2017
Source Palacky University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date September 19, 2017
Est. primary completion date July 16, 2017
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Balance training
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.

Locations

Country Name City State
Czechia Faculty of Physical Culture, Palacky University Olomouc Olomouc

Sponsors (1)

Lead Sponsor Collaborator
Palacky University

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline Berg balance scale score after completing intervention 2 months
Primary Change from baseline mean velocity of centre of pressure during quiet stance after completing intervention 2 months
Primary Change from baseline stride time variability after completing intervention 2 months
Secondary Change from baseline Falls efficacy scale - International score after completing intervention 2 months
Secondary Change from baseline gait velocity after completing intervention 2 months
Secondary Change from baseline short-term Lyapunov exponents after completing intervention 2 months
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