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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05893303
Other study ID # BAYEK022.04
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 31, 2023
Est. completion date May 15, 2024

Study information

Verified date July 2023
Source European University of Lefke
Contact Hasan Cellatoglu, PT, MSc
Phone 00905428774661
Email hasancellatoglu96@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Proprioceptive neuromuscular facilitation (PNF) has been defined as a comprehensive rehabilitation approach focusing on a motor learning effect, especially in the elderly. Therefore, PNF can be an effective treatment method for our purpose which is to analyze if PNF techniques improve balance and gait characteristics in elderly with scapular disposition and to determine the difference when used with the gait education


Description:

Participants will be randomly divided into 2 groups. Scapular PNF techniques in addition to gait training will be applied to the 1st group for 8 weeks, and only gait training exercises will be applied to the 2nd group for 8 weeks. Individuals will be evaluated in detail at the beginning, and end of the study, and after 3 months as a follow-up evaluation. For the assessment of scapular disposition, the Visual Scapular Disposition Test and Lateral Scapular Slide Test will be applied. Walking Speed will be evaluated with a dedicated area by measuring the distance. The Modified Dynamic Gait Index will be used for measuring the ability of the participant to maintain walking balance while responding to different task demands. For fall risks and functional mobility Timed Up and Go Test and Falls Efficacy Scale will be used. For balance assessment Berg Balance Scale and Functional Reach Test. For assessment of the quality of life, SF-36 will be used. Posture will be assessed with a dedicated application called PostureCo


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date May 15, 2024
Est. primary completion date December 15, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years to 74 Years
Eligibility Inclusion Criteria: - Having scapular disposition (Patients will be determined after the visual scapular disposition test and lateral scapular slide test) - With no injuries - Able to walk without any assistive devices - To be able to read and write in Turkish Exclusion Criteria: - Having a musculoskeletal or neurological problem that causes issues with applying the intervention. - Any orthopedic, neurological, cardiac, vestibular, visual, or psychiatric impairment which would not allow them to perform - Had physiotherapy during the past 3 months

Study Design


Related Conditions & MeSH terms


Intervention

Other:
1st Group
1st group is going to undergo scapula-oriented PNF techniques (diagonal) which are anterior elevation and posterior depression - posterior elevation and anterior depression with 20 repetitions with rhythmic initiation and repeated contractions facilitation techniques during all patterns. In addition to PNF techniques, gait training is going to be applied as standing with balance exercises (15 repetitions) as well as specific exercises for the stance and swing phases of the gait which are; stepping forward and sideways (15 repetitions), and gait education (walking 3 lapses within 2 meters parallel bar)
2nd Group
2nd group is going to undergo only gait training and balance exercises (15 repetitions) as well as specific exercises for the stance and swing phases of the gait which are; stepping forward and sideways (15 repetitions), and gait education (walking 3 lapses within 2 meters parallel bar)

Locations

Country Name City State
Turkey Fizyomorfo Fizyoterapi Rehabilitasyon ve Saglikli Yasam Merkezi Guzelyurt Trnc

Sponsors (1)

Lead Sponsor Collaborator
European University of Lefke

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Scapular Disposition Test During the visual scapular disposition test, patients will be asked to perform bilateral shoulder elevation movements and scapular movements will be observed in order to determine scapular dyskinesia 5 minutes
Primary Lateral Scapular Slide Test During the lateral scapular slide test, patients will be evaluated in 3 different arm positions while standing. at each position, special measurements of the scapula will be taken with measurement tape. If the difference between measurements in the same position is more than 1.5 centimeters (cm), the patient will be recorded as having scapular dyskinesia 5 minutes
Primary Walking Speed Participants normal walking speed measurement will be taken by asking patient to walk a dedicated 15m line and normal walking speed will be measured after 3 repetitions average time calculated 5 minutes
Primary Modified Dynamic Gait Index (mDGI) The DGI tests the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions. 10 minutes
Primary Timed Up and Go Test The timed "get up and walk" test is the basic functional mobility test for the elderly which they will be asked to stand up from a regular chair, walk 3 meters, turn and walk back to the chair and sit. 5 minutes
Primary Berg Balance Scale Berg Balance Scale (BDI) is generally used to measure balance performance in elderly patients. It is effective in assessing postural control and predicting fall risk. 5 minutes
Primary Functional Reach Test Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for assessing dynamic balance in one simple task. It will be done in the standing position, by measuring the distance between the length of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support, and this information is correlated with the risk of falling 5 minutes
Primary Falls Efficacy Scale The Falls Efficacy Scale is a short, easy to administer tool that measures the level of concern about falling during social and physical activities inside and outside the home whether or not the person actually does the activity. 5 minutes
Primary PostureCO PostureCo, Inc. is a technology company focusing on posture and movement analysis, it takes the data for the posture and movements. A special posture application for mobile phones will be used to determine postural sway. Data will be collected by scanning each patient and analyzing the posture. 5 minutes
Primary SF-36 The 36-item Short Form (SF-36) is a commonly used questionnaire for measuring health-related quality of life. Each patient will be asked to answer the questions in order to get the results for the quality of life 5 minutes
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