Geriatric RehabilitationNCT05893303
Effect of Proprioceptive Neuromuscular Facilitation Techniques on Elderly People with Scapular Disposition
A study testing 1st Group and 2nd Group in people with Geriatric Rehabilitation and Scapular Dyskinesis, run by European University of Lefke at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 65 to 74 years
- Conditions the study is for
- Geriatric Rehabilitation, Scapular Dyskinesis
- What is being tested?
- 1st Group and 2nd Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 May 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 74 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fizyomorfo Fizyoterapi Rehabilitasyon ve Saglikli Yasam Merkezi
Güzelyurt, TRNC, 99750
About this study
Official title: 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
Read the 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
- Conditions
- Geriatric Rehabilitation, Scapular Dyskinesis
- Being tested
- 1st Group, 2nd Group
- Keywords
- Geriatric Rehabilitation, Scapular Disposition, Balance, Posture, Gait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1st GroupOther
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 GroupOther
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)
| Study group | Role | What they receive |
|---|---|---|
| PNF Technique Group | Experimental | Participants in this group will receive PNF techniques and gait training 3 times per week for 8 weeks Receives: Other: 1st Group |
| Gait Training Group | Active comparator | Participants in this group will receive only gait training 3 times per week for 8 weeks Receives: Other: 2nd Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 minutes
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
Measured: 5 minutes
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
Measured: 5 minutes
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.
Measured: 10 minutes
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.
Measured: 5 minutes
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.
Measured: 5 minutes
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
Measured: 5 minutes
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.
Measured: 5 minutes
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.
Measured: 5 minutes
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
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start31 May 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- European University of Lefke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beliz Belgen Kaygisiz, PT, PhD, Principal investigator, European University of Lefke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893303
- Sponsor's protocol ID
- BAYEK022.04
- Status last verified
- Jul 2023
- First submitted
- 30 May 2023
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Proprioceptive Neuromuscular Facilitation (PNF) Techniques on Balance and Gait Characteristics of Elderly People with Scapular Disposition: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05893303
- Acronym / sponsor ID
- BAYEK022.04
- Conditions
- Geriatric Rehabilitation, Scapular Dyskinesis
- Keywords
- Geriatric Rehabilitation, Scapular Disposition, Balance, Posture, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- European University of LefkeUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNF Technique Group | Experimental | Other: 1st GroupParticipants in this group will receive PNF techniques and gait training 3 times per week for 8 weeks |
| Gait Training Group | Active comparator | Other: 2nd GroupParticipants in this group will receive only gait training 3 times per week for 8 weeks |
Who may qualify
- Ages
- 65 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1st Group1st 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) | Other | PNF Technique Group |
| 2nd Group2nd 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) | Other | Gait Training Group |
Primary outcome
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
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
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
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.
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.
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.
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
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beliz Belgen Kaygisiz, PT, PhD principal investigator
European University of Lefke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1st Group and 2nd Group in people with Geriatric Rehabilitation and Scapular Dyskinesis, run by European University of Lefke at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Scapular Disposition Test (time frame: 5 minutes). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.