- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04423497
ESTIMATION OF BALANCE STATUS IN HEMIPARETICS
ESTIMATION OF BALANCE STATUS IN PATIENTS WITH HEMIPARESIS: AN ARTIFICIAL NEURAL NETWORK IMPLEMENTATION
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The demographics and clinical information of the participants' were recorded. Clinical information consists of some basic medical data for the patients. Hodkinson Mental Test was used to assess the cognitive status of the participants if they met inclusion criteria. Balance Evaluation Systems Test was used to assess balance status of the participants.
Feed-forward back-propagation ANNs was used in this study by employing Levenberg-Marquardt training algorithm. Tangent hyperbolic transfer functions were used in the hidden layer. Matlab (Version R2017b, Mathworks Inc, USA) was used in ANNs modeling. 70% (n=46), 15% (n=10) and 15% (n=10) of the data obtained from the participants were used for training, validation and test in the study, respectively. Multiple linear regression (MLR) models also were used to compare with ANNs.
Firstly, the ANNs were modeled for the first aim of the study. We used the data of the five traditional balance tests in the BESTest that did not use the real values (the timing or distance), but just the classified values (0-3 points in the BESTest) to train ANNs. Five balance tests were functional reach test (cm), one leg standing test for right and left side (sec), 6-metre timed walk test (sec) and timed up and go test (sec). Then, we compare the manual total BESTest scores with the predicted scores by the ANNs.
Secondly, we removed 6 sections of the BESTest one by one and modeled with the remaining 5 sections of the test to estimate the total BESTest score. After this modeling, we removed each item one by one in the first section and estimated the first section total score. We repeated the process for all the sections of the BESTest.
Statistical Analysis
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being aged between 35-65 years,
- Able to walk independently or with a walking aid,
- Able to stand at least 1 minute independently,
- Having single hemiparesis,
- Getting at least 8 points from Hodkinson Mental Test.
Exclusion Criteria:
- Having comorbidities affecting their balance,
- Having communication problems.
- Patients who cannot comprehend the directions given to them were excluded from the study.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance Evaluation Systems Test (BESTest)
Time Frame: two years
|
Biomechanical constraints, stability limits/verticality, anticipatory postural adjustments, postural responses, sensory orientation and stability in gait
|
two years
|
|
Artificial Neural Networks Modeling
Time Frame: two years
|
comparing the manual total BESTest scores with the predicted scores by the ANNs
|
two years
|
|
Artificial Neural Networks Modeling
Time Frame: two years
|
determining the highest contributions of BESTest subsets in order to find ANNs predictive results of BESTest subsets.
|
two years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Güzin Kara, PhD, PT, Pamukkale University
Publications and helpful links
General Publications
- Kaczmarczyk K, Wit A, Krawczyk M, Zaborski J, Gajewski J. Associations between gait patterns, brain lesion factors and functional recovery in stroke patients. Gait Posture. 2012 Feb;35(2):214-7. doi: 10.1016/j.gaitpost.2011.09.009. Epub 2011 Sep 19.
- Demir U, Kocaoğlu S, Akdoğan E. Human impedance parameter estimation using artificial neural network for modelling physiotherapist motion. Biocybernetics and Biomedical Engineering. 2016; 36(2): 318-326
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 60116787-020/5431
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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