Effect of Proprioceptive Neuromuscular Facilitation Techniques on Elderly People with Scapular Disposition

October 3, 2024 updated by: European University of Lefke

Effect of Proprioceptive Neuromuscular Facilitation (PNF) Techniques on Balance and Gait Characteristics of Elderly People with Scapular Disposition: a Randomized Controlled Trial

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Trnc
      • Guzelyurt, Trnc, Turkey, 99750
        • Fizyomorfo Fizyoterapi Rehabilitasyon ve Saglikli Yasam Merkezi

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PNF Technique Group
Participants in this group will receive PNF techniques and gait training 3 times per week for 8 weeks
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)
Active Comparator: Gait Training Group
Participants in this group will receive only gait training 3 times per week for 8 weeks
Other: 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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Scapular Disposition Test
Time Frame: 5 minutes
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
Lateral Scapular Slide Test
Time Frame: 5 minutes
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
Walking Speed
Time Frame: 5 minutes
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
Modified Dynamic Gait Index (mDGI)
Time Frame: 10 minutes
The DGI tests the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions.
10 minutes
Timed Up and Go Test
Time Frame: 5 minutes
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
Berg Balance Scale
Time Frame: 5 minutes
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
Functional Reach Test
Time Frame: 5 minutes
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
Falls Efficacy Scale
Time Frame: 5 minutes
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
PostureCO
Time Frame: 5 minutes
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
SF-36
Time Frame: 5 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
European University of Lefke

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Beliz Belgen Kaygisiz, PT, PhD, European University of Lefke

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BAYEK022.04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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