Caregiver BurdenNCT06466239
PNF Method for Those Working in Special Education
A study testing PNF Stretching and Static Stretching in people with Caregiver Burden, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to examine the acute effect of self-proprioceptive neuromuscular facilitation (PNF) stretching on chest mobility, posterior muscle chain mobility and respiratory functions in caregivers of children with developmental delays. In the study: 1. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- PNF Stretching and Static Stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Nov 2023to 6 Jun 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteering to participate in the study
- No history of infection or flare in the previous 4 weeks
- Participants who have not been included in another clinical trial in the last month
- Those whose knee flexion angle is 15 degrees and above in the hamstring muscle shortness test
Who cannot join
- Vestibular disorders, participants with known balance impairment within the past three months due to concussion
- Those with musculoskeletal system problems in their lower extremities
- Those who had lower extremity and thorax surgery in the last year
- Those with metabolic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effect of Self-PNF Stretching on Chest Mobility, Posterior Muscle Chain Mobility and Respiratory Functions in Caregivers of Children With Developmental Delays
The aim of the study was to examine the acute effect of self-proprioceptive neuromuscular facilitation (PNF) stretching on chest mobility, posterior muscle chain mobility and respiratory functions in caregivers of children with developmental delays. In the study: 1. Does self-PNF stretching have an effect on chest mobility and posterior muscle chain mobility in caregivers of children with developmental delay? 2. Does self-PNF stretching have an effect on respiratory functions in caregivers of children with developmental delays? The questions were answered.
Read the detailed description
A cross-over randomized controlled study was designed with 30 caregivers of children with developmental disabilities. Using the online randomization method, caregivers were first assigned to either the PNF stretching group or the static stretching group. Before and after the application, rib cage mobility was evaluated by chest circumference measurement, hamstring muscle mobility by popliteal angle measurement, lumbar region mobility by Schober Test, posterior muscle chain mobility by Finger-Floor Distance Measurement Test, and respiratory functions by Respiratory Function Test. The caregiver, who entered a 1-day cleansing period, repeated the evaluation and technique application with the stretching technique that was not applied the next day.
- Conditions
- Caregiver Burden
- Being tested
- PNF Stretching, Static Stretching
- Keywords
- maintenance burden, PNF technique, rehabilitation worker
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNF StretchingOther
PNF was applied to the hamstring muscle, with a 1-day washout period in between.
Static StretchingOther
Static stretching was applied to the hamstring muscle, with a 1-day washout period in between.
| Study group | Role | What they receive |
|---|---|---|
| PNF Stretching Group | Experimental | The PNF stretching method for each muscle was applied to the athlete in the form of self-stretching by the participant, with the direct treatment concept of hold and relax technique, with the training of a specialist physiotherapist. The muscle to be stretched (the antagonist muscle for the pattern - the muscle that causes the limitation) was first brought to the position where it could be extended, and at that point, the stretched muscle was contracted submaximally (65% of the intensity determined according to the Stretch Intensity Scale) for 5 seconds, causing isometric contraction. Then, the athlete was given 5 relax commands for the tense muscle. Then, the stretched muscle was stretched as far as it could go, and the muscle that needed to be stretched was passively stretched for 20 seconds (1 set). After a 5-second rest interval, the method was repeated and 8 sets (lasting 4 minutes) were performed for 1 muscle. Stretching was done on the hamstring muscle. Receives: Other: PNF Stretching |
| Static Stretching Group | Other | Classical static stretching was applied to the hamstring muscle in the same position for 30 seconds each, 8 repetitions, a total of 4 minutes for one leg and 8 minutes for both legs, in the stance position of PNF stretching. Receives: Other: Static Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest Mobility Measurement 1- Axillary region
Normal resting tidal volume, chest width during maximum inspiration and maximum expiration were measured from the axillary region with a tape measure and recorded in centimeters.
Measured: Duration of change in 1 day.
Chest Mobility Measurement 2- Xiphoid region
Normal resting tidal volume, chest width during maximum inspiration and maximum expiration were measured from the xiphoid (epigastric) region with a tape measure and recorded in centimeters.
Measured: Duration of change in 1 day.
Chest Mobility Measurement 3- Subcostal region
Normal resting tidal volume, chest width during maximum inspiration and maximum expiration were measured from the subcostal region with a tape measure and recorded in centimeters.
Measured: Duration of change in 1 day.
Secondary outcomes (5)
Popliteal Angle Measurement
Hamstring muscle flexibility measurement. A digital goniometer was used.
Measured: Duration of change in 1 day.
Schober Test
Lumbar mobility was evaluated with the Schober Test. A tape measure was used in the testing procedure.
Measured: Duration of change in 1 day.
Posterior muscle chain mobility measurement
Posterior muscle chain mobility was evaluated with the Finger-Floor Distance Test. A tape measure was used in the testing procedure.
Measured: Duration of change in 1 day.
FVC Measurement
Respiratory Function Test. The COSMED microQuark spirometer used. Lung volume was evaluated.
Measured: Duration of change in 1 day.
FEV1 Measurement
Respiratory Function Test. The COSMED microQuark spirometer used. Lung volume was evaluated.
Measured: Duration of change in 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start4 Nov 2023
- Primary completion12 Mar 2024
- Study completion6 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caregiver BurdenStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Gedik University
- Responsible party
- Principal investigator, ebrar atak, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466239
- Sponsor's protocol ID
- PNFEffectsForCaregiver
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be evaluated if the researchers are contacted via their e-mail addresses.
Publications
Reiner M, Tilp M, Guilhem G, Morales-Artacho A, Nakamura M, Konrad A. Effects of a Single Proprioceptive Neuromuscular Facilitation Stretching Exercise With and Without Post-stretching Activation on the Muscle Function and Mechanical Properties of the Plantar Flexor Muscles. Front Physiol. 2021 Sep 14;12:732654. doi: 10.3389/fphys.2021.732654. eCollection 2021.
PubMed 34594241
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Self-PNF Stretching on Chest Mobility, Posterior Muscle Chain Mobility and Respiratory Functions in Caregivers of Children With Developmental Delays
- ClinicalTrials.gov ID
- NCT06466239
- Acronym / sponsor ID
- PNFEffectsForCaregiver
- Conditions
- Caregiver Burden
- Keywords
- maintenance burden, PNF technique, rehabilitation worker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Istanbul Gedik University
- Study start
- 4 Nov 2023 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 20 Jun 2024 (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.
The aim of the study was to examine the acute effect of self-proprioceptive neuromuscular facilitation (PNF) stretching on chest mobility, posterior muscle chain mobility and respiratory functions in caregivers of children with developmental delays. In the study: 1. Does self-PNF stretching have an effect on chest mobility and posterior muscle chain mobility in caregivers of children with developmental delay? 2. Does self-PNF stretching have an effect on respiratory functions in caregivers of children with developmental delays? The questions were answered.
Detailed description
A cross-over randomized controlled study was designed with 30 caregivers of children with developmental disabilities. Using the online randomization method, caregivers were first assigned to either the PNF stretching group or the static stretching group. Before and after the application, rib cage mobility was evaluated by chest circumference measurement, hamstring muscle mobility by popliteal angle measurement, lumbar region mobility by Schober Test, posterior muscle chain mobility by Finger-Floor Distance Measurement Test, and respiratory functions by Respiratory Function Test. The caregiver, who entered a 1-day cleansing period, repeated the evaluation and technique application with the stretching technique that was not applied the next day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNF Stretching Group | Experimental | Other: PNF StretchingThe PNF stretching method for each muscle was applied to the athlete in the form of self-stretching by the participant, with the direct treatment concept of hold and relax technique, with the training of a specialist physiotherapist. The muscle to be stretched (the antagonist muscle for the pattern - the muscle that causes the limitation) was first brought to the position where it could be extended, and at that point, the stretched muscle was contracted submaximally (65% of the intensity determined according to the Stretch Intensity Scale) for 5 seconds, causing isometric contraction. Then, the athlete was given 5 relax commands for the tense muscle. Then, the stretched muscle was stretched as far as it could go, and the muscle that needed to be stretched was passively stretched for 20 seconds (1 set). After a 5-second rest interval, the method was repeated and 8 sets (lasting 4 minutes) were performed for 1 muscle. Stretching was done on the hamstring muscle. |
| Static Stretching Group | Other | Other: Static StretchingClassical static stretching was applied to the hamstring muscle in the same position for 30 seconds each, 8 repetitions, a total of 4 minutes for one leg and 8 minutes for both legs, in the stance position of PNF stretching. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Volunteering to participate in the study
- No history of infection or flare in the previous 4 weeks
- Participants who have not been included in another clinical trial in the last month
- Those whose knee flexion angle is 15 degrees and above in the hamstring muscle shortness test
Key exclusion criteria (4 listed)
- Vestibular disorders, participants with known balance impairment within the past three months due to concussion
- Those with musculoskeletal system problems in their lower extremities
- Those who had lower extremity and thorax surgery in the last year
- Those with metabolic diseases
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 |
|---|---|---|
| PNF StretchingPNF was applied to the hamstring muscle, with a 1-day washout period in between. | Other | PNF Stretching Group |
| Static StretchingStatic stretching was applied to the hamstring muscle, with a 1-day washout period in between. | Other | Static Stretching Group |
Primary outcome
Chest Mobility Measurement 1- Axillary region
Time frame: Duration of change in 1 day.
Normal resting tidal volume, chest width during maximum inspiration and maximum expiration were measured from the axillary region with a tape measure and recorded in centimeters.
Chest Mobility Measurement 2- Xiphoid region
Time frame: Duration of change in 1 day.
Normal resting tidal volume, chest width during maximum inspiration and maximum expiration were measured from the xiphoid (epigastric) region with a tape measure and recorded in centimeters.
Chest Mobility Measurement 3- Subcostal region
Time frame: Duration of change in 1 day.
Normal resting tidal volume, chest width during maximum inspiration and maximum expiration were measured from the subcostal region with a tape measure and recorded in centimeters.
5 secondary outcomes
Popliteal Angle Measurement
Time frame: Duration of change in 1 day.
Schober Test
Time frame: Duration of change in 1 day.
Posterior muscle chain mobility measurement
Time frame: Duration of change in 1 day.
FVC Measurement
Time frame: Duration of change in 1 day.
FEV1 Measurement
Time frame: Duration of change in 1 day.
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 20 Jun 2024.
- Background: PubMed 34594241Reiner M, Tilp M, Guilhem G, Morales-Artacho A, Nakamura M, Konrad A. Effects of a Single Proprioceptive Neuromuscular Facilitation Stretching Exercise With and Without Post-stretching Activation on the Muscle Function and Mechanical Properties of the Plantar Flexor Muscles. Front Physiol. 2021 Sep 14;12:732654. doi: 10.3389/fphys.2021.732654. eCollection 2021.
- Individual participant dataSharing planned: No. It will be evaluated if the researchers are contacted via their e-mail addresses.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNF Stretching and Static Stretching in people with Caregiver Burden, run by Istanbul Medipol University Hospital 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 4 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 20 Jun 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?
Chest Mobility Measurement 1- Axillary region (time frame: Duration of change in 1 day.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06466239, which also lists 1 linked publication.
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 20 Jun 2024.