KyphosiskinesioNCT06246474
Impact of Kinesio Taping on Kyphosis and Quality of Life in Adolescents
A study testing physical therapy program in people with Kyphosis and Kyphosis Thoracic, run by Cairo University at 1 site in Egypt.
Trial summary
Kyphosis, a posture disorder, is excessive curvature of the thoracic area in the spine. In a healthy person, there is a normal kyphosis angulation in the thoracic and sacral areas in the sagittal plane. Since the sacral area is more stable, pathological conditions generally occur in the thoracic area. Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Kyphosis, Kyphosis Thoracic, Kyphosis Postural Thoracic
- What is being tested?
- physical therapy program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Apr 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 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Their age will be ranged from 15 to 18 years.
- They will have forward head posture.
- They will have postural kyphosis with Cobb\'s angle more than 45 degree.
- Their body mass index of female adolescents will be ranged between (19.5 - 20.7)
Who cannot join
- Visual or hearing defects.
- Congenital anomalies in spine region.
- Fractures of upper limb.
Trial locations and contacts
1 site in 1 country.
About this study
Kyphosis, a posture disorder, is excessive curvature of the thoracic area in the spine. In a healthy person, there is a normal kyphosis angulation in the thoracic and sacral areas in the sagittal plane. Since the sacral area is more stable, pathological conditions generally occur in the thoracic area.
Kyphosis causes a bowing of the back, which leads to a hunchback or slouching posture. Normal values for the thoracic kyphosis are between 20˚ and 40˚ of angulations. When the curve of the thoracic spine exceeds this, it is described as either a postural kyphosis or Scheuermann\'s kyphosis.
The study question is: Does kinesio taping have an effect on kyphosis and quality of life in adolescents?
Read the detailed description
The purpose of the study is to determine the effects of kinesio taping on:
- Kyphotic curve.
- Forward head posture.
- Quality of life in adolescents. Postural kyphosis is the most common type that causes slouching in thoracic curve can occur in young age, it can be called \'slouching\' and is reversible by correcting muscular imbalances.
Adolescent\'s kyphosis curve appear by bad habitual postures due to a carry-over effect from temporary changes in posture during computer use and smart phones.
Forward head posture (FHP) is characterized that cervical spine is held in protracted position for prolonged duration, it can lead to alterations in head posture ultimately leading to poor posture which is thought to be a deviation from neutral or normal posture.
Failure of the head to align with the vertical axis of the body can lead to further malalignments in the body, namely, rounded shoulders and increased thoracic kyphosis, to compensate for the altered location of the LOG, leading to further impairments . A combination of all these postural deviations is often known as "slouched posture" or "slumped posture." The Kinesio taping method was applied to correct the alignment of weak muscles as well as facilitating joint motion as a result of the tape\'s recoiling qualities. It was designed to be the approximate thickness and elasticity of skin and be worn three to five days at a time.
Kinesio taping is a therapeutic tool used with increasing frequency within musculoskeletal rehabilitation and to maintain preferred body alignment. It is a complementary treatment and is designed to facilitate the body's natural healing, Process while allowing support and stability to 5 muscles and joints without restricting the body's range of motion.
Due to the lack of research area of kinesio taping on kyphosis in adolescents, So, the purpose of the study is to know impact of the Kinesio taping on kyphosis and quality of life in adolescents.
- Conditions
- Kyphosis, Kyphosis Thoracic, Kyphosis Postural Thoracic
- Being tested
- physical therapy program
- Keywords
- kyphosis, postural kyphosis, Forward head posture, Adolseccent
- Medical subject headings
- Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapy programProcedure or surgery
Also called Kinesio taping
Arm Description: Adolescents in study group (B) will received the same designed physical therapy program for the control group in addition to Kinesio taping.
| Study group | Role | What they receive |
|---|---|---|
| control group (A) | No intervention | Adolescents in control group (A) will received a designed physical therapy program for the treatment of thoracic kyphosis |
| group (B) | Experimental | Adolescents in study group (B) will received the same designed physical therapy program for the control group in addition to Kinesio taping. Receives: Procedure: physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
cobbs angle x-ray for selection of the patient
Full length AP (anterior/ posterior, front/ back ) film x-ray will be taken of the spinal column ,these x- rays will be used to determine curve flexibility and evaluate vertebral wedging and end plate irregularities
Measured: 2 months
inclinometer for selection patients of kyphotic curve measurements
Two gravity-dependent inclinometers (Isomed, Inc, USA) will be used. The feet of the inclinometers were 2.5 cm apart, which remained constant for all subjects, manual inclinometer probes, the two MEMS sensors are mounted 90 degree
Measured: 2 months
modified baseline goniometer for FHP angle's measurement
The modified goniometer is a simple and cost-effective modification of the universal goniometer; it has an excellent reliability and validity method for objectively assessing forward head posture.
Measured: 2 months
quality of life questionnaire (PEDS) for quality of life
Pediatric Quality of Life Inventory (PedsQL) Module3.0 will be used to assess QOL of all adolescents. Arabic version will be used in this study (Shemy et al., 2019) (Appendix III). The parent will be asked about the grade of the problem of each item that the adolescents had in the past month.
Measured: 2 months
Tape measurment for chest expansion range of motion.
Tape measurment for chest expansion range of motion.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Jan 2024
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KyphosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa abd elmohsen ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246474
- Sponsor's protocol ID
- P.T.REC/012/004905
- Other IDs
- P.T.REC/012/004905
- Acronym
- kinesio
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to University rules
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Kinesio Taping on Kyphosis and Quality of Life in Adolescents
- ClinicalTrials.gov ID
- NCT06246474
- Acronym / sponsor ID
- kinesio / P.T.REC/012/004905
- Conditions
- Kyphosis, Kyphosis Thoracic, Kyphosis Postural Thoracic
- Keywords
- kyphosis, postural kyphosis, Forward head posture, Adolseccent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 7 Feb 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.
Kyphosis, a posture disorder, is excessive curvature of the thoracic area in the spine. In a healthy person, there is a normal kyphosis angulation in the thoracic and sacral areas in the sagittal plane. Since the sacral area is more stable, pathological conditions generally occur in the thoracic area.
Kyphosis causes a bowing of the back, which leads to a hunchback or slouching posture. Normal values for the thoracic kyphosis are between 20˚ and 40˚ of angulations. When the curve of the thoracic spine exceeds this, it is described as either a postural kyphosis or Scheuermann\'s kyphosis.
The study question is: Does kinesio taping have an effect on kyphosis and quality of life in adolescents?
Detailed description
The purpose of the study is to determine the effects of kinesio taping on:
- Kyphotic curve.
- Forward head posture.
- Quality of life in adolescents. Postural kyphosis is the most common type that causes slouching in thoracic curve can occur in young age, it can be called \'slouching\' and is reversible by correcting muscular imbalances.
Adolescent\'s kyphosis curve appear by bad habitual postures due to a carry-over effect from temporary changes in posture during computer use and smart phones.
Forward head posture (FHP) is characterized that cervical spine is held in protracted position for prolonged duration, it can lead to alterations in head posture ultimately leading to poor posture which is thought to be a deviation from neutral or normal posture.
Failure of the head to align with the vertical axis of the body can lead to further malalignments in the body, namely, rounded shoulders and increased thoracic kyphosis, to compensate for the altered location of the LOG, leading to further impairments . A combination of all these postural deviations is often known as "slouched posture" or "slumped posture." The Kinesio taping method was applied to correct the alignment of weak muscles as well as facilitating joint motion as a result of the tape\'s recoiling qualities. It was designed to be the approximate thickness and elasticity of skin and be worn three to five days at a time.
Kinesio taping is a therapeutic tool used with increasing frequency within musculoskeletal rehabilitation and to maintain preferred body alignment. It is a complementary treatment and is designed to facilitate the body's natural healing, Process while allowing support and stability to 5 muscles and joints without restricting the body's range of motion.
Due to the lack of research area of kinesio taping on kyphosis in adolescents, So, the purpose of the study is to know impact of the Kinesio taping on kyphosis and quality of life in adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group (A) | No intervention | –Adolescents in control group (A) will received a designed physical therapy program for the treatment of thoracic kyphosis |
| group (B) | Experimental | Procedure: physical therapy programAdolescents in study group (B) will received the same designed physical therapy program for the control group in addition to Kinesio taping. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Their age will be ranged from 15 to 18 years.
- They will have forward head posture.
- They will have postural kyphosis with Cobb\'s angle more than 45 degree.
- Their body mass index of female adolescents will be ranged between (19.5 - 20.7)
Key exclusion criteria (3 listed)
- Visual or hearing defects.
- Congenital anomalies in spine region.
- Fractures of upper limb.
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 |
|---|---|---|
| physical therapy programAlso: Kinesio tapingArm Description: Adolescents in study group (B) will received the same designed physical therapy program for the control group in addition to Kinesio taping. | Procedure or surgery | group (B) |
Primary outcome
cobbs angle x-ray for selection of the patient
Time frame: 2 months
Full length AP (anterior/ posterior, front/ back ) film x-ray will be taken of the spinal column ,these x- rays will be used to determine curve flexibility and evaluate vertebral wedging and end plate irregularities
inclinometer for selection patients of kyphotic curve measurements
Time frame: 2 months
Two gravity-dependent inclinometers (Isomed, Inc, USA) will be used. The feet of the inclinometers were 2.5 cm apart, which remained constant for all subjects, manual inclinometer probes, the two MEMS sensors are mounted 90 degree
modified baseline goniometer for FHP angle's measurement
Time frame: 2 months
The modified goniometer is a simple and cost-effective modification of the universal goniometer; it has an excellent reliability and validity method for objectively assessing forward head posture.
quality of life questionnaire (PEDS) for quality of life
Time frame: 2 months
Pediatric Quality of Life Inventory (PedsQL) Module3.0 will be used to assess QOL of all adolescents. Arabic version will be used in this study (Shemy et al., 2019) (Appendix III). The parent will be asked about the grade of the problem of each item that the adolescents had in the past month.
Tape measurment for chest expansion range of motion.
Time frame: 2 months
Tape measurment for chest expansion range of motion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: Undecided. Due to University rules
Related trials for Kyphosis
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Basic Body Awareness Therapy (BBAT) and Corrective Exercise for Adolescent Hyperkyphosis
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Surface Electromyographic Analysis of Scapular Stabilizer Muscle in Postural Hyperkyphosis
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Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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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 physical therapy program in people with Kyphosis and Kyphosis Thoracic, run by Cairo University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 7 Feb 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 Egypt. 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?
Results are not available in the source record.
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?
cobbs angle x-ray for selection of the patient (time frame: 2 months). The study lists 5 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 7 Feb 2024.