KyphosisNCT05063175
Correction for Kyphotic Posture for Improving Balance in Cerebral Palsy
A study testing Conventional Physical Therapy Protocol and TheraTog orthotic undergarment with its strapping system in people with Kyphosis, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial summary
Children with spastic diplegia are at an increased risk of spinal deformities. The most common types of these spinal deformities are scoliosis and kyphosis. Thoracic hyper-kyphosis may adversely affect balance in children with cerebral palsy . Read more about this study
- Who is it for?
- Ages 8 to 10 years
- Conditions the study is for
- Kyphosis
- What is being tested?
- Conventional Physical Therapy Protocol and TheraTog orthotic undergarment with its strapping system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2018to 30 Apr 2021
- 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 8 to 10 years
- All sexes
- No healthy volunteers
- Child
The inclusion criteria were:
- Children with a diagnosis of cerebral palsy of spastic diplegia.
- They were all between 8 and 10 years old, of both sexes.
- The degree of spasticity in the affected upper and lower extremity, was ranged between grades (1, 1+\&2) according to Modified Ashworth Scale (MAS).
- Children were cognitively able to understand and follow instructions.
- The levels of their gross motor function were between level I and II according to the Gross - Motor Function Classification System (GMFCS).
- They were able to stand alone for five to ten minutes without any assistance.
- The degree of the spinal kyphosis in the sagittal plane did not exceed 45° (Cobb's angle).
The exclusion criteria were:
- Children with any orthopedic condition or fixed deformity that interfere with the spinal and limbs functions.
- Children who demonstrated allergic reactions to the adhesive tape or any other materials used in this study.
- Children with surgical interference for the lower limb and spine within the previous 2 years.
- Children with seizures, visual impairments, or perceptual problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influences of Kyphotic Posture Correction on Balance and Risk of Fall in Children With Cerebral Palsy.
Children with spastic diplegia are at an increased risk of spinal deformities. The most common types of these spinal deformities are scoliosis and kyphosis. Thoracic hyper-kyphosis may adversely affect balance in children with cerebral palsy . The treatment approaches for hyper-kyphosis involved both conservative and surgical treatments. The Conservative approach includes corrective exercises, positioning, and spinal braces. This study aimed to evaluate the effect of conservative orthotic management for kyphotic posture on balance control, and fall risk in cerebral palsied children of spastic diplegia.
Read the detailed description
Kyphosis is a posterior convexity of the spine. Children with cerebral palsy show a higher probability of progression of the kyphotic curve. If it is not adequately treated, it becomes fixed where it requires surgical management. Children with cerebral palsy have more probability to balance impairment and falls than normal children and the consequences of that fall are great. The current studies do not properly examine the effectiveness of conservative orthoses on the therapeutic management of kyphosis in children with cerebral palsy. Also, there is a shortage of studies that evaluate how correction of the thoracic kyphosis influences the balance performance and fall risk in children with cerebral palsy. TheraTogs orthosis which consists of an orthotic undergarment and external strapping system has been designed to provide a soft and passive body compression to maintain a typical body postural alignment and to improve posture control. Therefore, the objective of this study was to investigate how the correction of dorsal hyper-kyphotic posture by the TheraTogs orthotic system could influence balance control, and fall risk in cerebral palsied children of spastic diplegia.
- Conditions
- Kyphosis
- Being tested
- Conventional Physical Therapy Protocol, TheraTog orthotic undergarment with its strapping system
- Keywords
- Kyphosis, Balance, Fall Risk
- Medical subject headings
- Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Physical Therapy ProtocolOther
The conventional physical therapy protocol was prescribed to correct the kyphotic posture of the dorsal spine, and improve postural balance stability during standing and walking. The conventional therapeutic protocol for every child was three sessions per week for 12 successive weeks. Every treatment session was applied for two hours with a few minutes rest in between them.
TheraTog orthotic undergarment with its strapping systemOther
TheraTog orthotic undergarment with its strapping system was conducted for 8 hours daily for 12 successive weeks. It is made to be fitted directly on the skin as undergarments.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Children in the control group received the conventional physical therapy protocol which was prescribed to correct the kyphotic posture of the dorsal spine, and improve postural balance stability during standing and walking. Receives: Other: Conventional Physical Therapy Protocol |
| Experimental Group | Experimental | The children in the experimental group received the conventional protocol applied to the control group. Further, they wore TheraTog orthotic undergarment with its strapping system for 8 hours daily for 12 successive weeks. Receives: Other: Conventional Physical Therapy Protocol; Other: TheraTog orthotic undergarment with its strapping system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the thoracic kyphosis angle (°)
The following device (DIERS Formetric 3D/4D spine \& posture analysis system) was used to examine the change in the thoracic kyphosis angle (°). This device supplies a thorough report about the alignment of the whole spine in one assessment session. It was used for assessing the sagittal plane of the back surface of the body according to a contactless 3D - scan.
Measured: [Data was collected at baseline, and 12 weeks after intervention commencement.]
Change in the thoracic flexion and extension range of motion (degree).
Spinal mouse, a computerized spinal evaluating device, was used for evaluating the range of motion of the spinal segment in a non-invasive way. The extension and flexion range of motion of the spine were measured by the spinal mouse. The measurements were recorded from the standing position of the children.
Measured: [Data was collected at baseline, and 12 weeks after intervention commencement.]
Change in the Overall Stability Indices {percentage value (%)} for the Fall Risk Test (test that assessed the change in postural stability)
The Biodex Balance System was used to assess the Change in the Overall Stability Index of the Fall Risk Test. In this study, the dynamic level 12 was selected for applying the fall risk test. The result for every child was registered and compared to the normative data stored in the software of the device based on children age range.
Measured: [Data was collected at baseline, and 12 weeks after intervention commencement.]
Change in the Pediatric Balance Scale score (scale that assess the change in balance performance)
The Pediatric Balance Scale is a functional test that is used to evaluate balance impairments in children with motor deficits. The test consists of 14 tasks that assess balance performance in children. 0-4 is the rating score for each item, where zero is the minimum score and 56 is the maximum score for all tasks.
Measured: [Data was collected at baseline, and 12 weeks after intervention commencement.]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start1 Jan 2018
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Mohamed Abd El Kafy, Umm Al-Qura University
- Investigators
- Ehab M Abd El Kafy, Ph.D, Principal investigator, Faculty of Applied Medical Sciences - Umm Al Qura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063175
- Sponsor's protocol ID
- 19-MED-01-0005
- Status last verified
- Oct 2021
- First submitted
- 21 Sep 2021
- Last updated
- 14 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: \- The data available is Case-by-case basis at the discretion of Primary Sponsor
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influences of Kyphotic Posture Correction on Balance and Risk of Fall in Children With Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT05063175
- Acronym / sponsor ID
- 19-MED-01-0005
- Conditions
- Kyphosis
- Keywords
- Kyphosis, Balance, Fall Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 30 Sep 2021 (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.
Children with spastic diplegia are at an increased risk of spinal deformities. The most common types of these spinal deformities are scoliosis and kyphosis. Thoracic hyper-kyphosis may adversely affect balance in children with cerebral palsy . The treatment approaches for hyper-kyphosis involved both conservative and surgical treatments. The Conservative approach includes corrective exercises, positioning, and spinal braces. This study aimed to evaluate the effect of conservative orthotic management for kyphotic posture on balance control, and fall risk in cerebral palsied children of spastic diplegia.
Detailed description
Kyphosis is a posterior convexity of the spine. Children with cerebral palsy show a higher probability of progression of the kyphotic curve. If it is not adequately treated, it becomes fixed where it requires surgical management. Children with cerebral palsy have more probability to balance impairment and falls than normal children and the consequences of that fall are great. The current studies do not properly examine the effectiveness of conservative orthoses on the therapeutic management of kyphosis in children with cerebral palsy. Also, there is a shortage of studies that evaluate how correction of the thoracic kyphosis influences the balance performance and fall risk in children with cerebral palsy. TheraTogs orthosis which consists of an orthotic undergarment and external strapping system has been designed to provide a soft and passive body compression to maintain a typical body postural alignment and to improve posture control. Therefore, the objective of this study was to investigate how the correction of dorsal hyper-kyphotic posture by the TheraTogs orthotic system could influence balance control, and fall risk in cerebral palsied children of spastic diplegia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Conventional Physical Therapy ProtocolChildren in the control group received the conventional physical therapy protocol which was prescribed to correct the kyphotic posture of the dorsal spine, and improve postural balance stability during standing and walking. |
| Experimental Group | Experimental | Other: Conventional Physical Therapy Protocol, Other: TheraTog orthotic undergarment with its strapping systemThe children in the experimental group received the conventional protocol applied to the control group. Further, they wore TheraTog orthotic undergarment with its strapping system for 8 hours daily for 12 successive weeks. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Conventional Physical Therapy ProtocolThe conventional physical therapy protocol was prescribed to correct the kyphotic posture of the dorsal spine, and improve postural balance stability during standing and walking. The conventional therapeutic protocol for every child was three sessions per week for 12 successive weeks. Every treatment session was applied for two hours with a few minutes rest in between them. | Other | Control Group, Experimental Group |
| TheraTog orthotic undergarment with its strapping systemTheraTog orthotic undergarment with its strapping system was conducted for 8 hours daily for 12 successive weeks. It is made to be fitted directly on the skin as undergarments. | Other | Experimental Group |
Primary outcome
Change in the thoracic kyphosis angle (°)
Time frame: [Data was collected at baseline, and 12 weeks after intervention commencement.]
The following device (DIERS Formetric 3D/4D spine \& posture analysis system) was used to examine the change in the thoracic kyphosis angle (°). This device supplies a thorough report about the alignment of the whole spine in one assessment session. It was used for assessing the sagittal plane of the back surface of the body according to a contactless 3D - scan.
Change in the thoracic flexion and extension range of motion (degree).
Time frame: [Data was collected at baseline, and 12 weeks after intervention commencement.]
Spinal mouse, a computerized spinal evaluating device, was used for evaluating the range of motion of the spinal segment in a non-invasive way. The extension and flexion range of motion of the spine were measured by the spinal mouse. The measurements were recorded from the standing position of the children.
Change in the Overall Stability Indices {percentage value (%)} for the Fall Risk Test (test that assessed the change in postural stability)
Time frame: [Data was collected at baseline, and 12 weeks after intervention commencement.]
The Biodex Balance System was used to assess the Change in the Overall Stability Index of the Fall Risk Test. In this study, the dynamic level 12 was selected for applying the fall risk test. The result for every child was registered and compared to the normative data stored in the software of the device based on children age range.
Change in the Pediatric Balance Scale score (scale that assess the change in balance performance)
Time frame: [Data was collected at baseline, and 12 weeks after intervention commencement.]
The Pediatric Balance Scale is a functional test that is used to evaluate balance impairments in children with motor deficits. The test consists of 14 tasks that assess balance performance in children. 0-4 is the rating score for each item, where zero is the minimum score and 56 is the maximum score for all tasks.
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 14 Oct 2021.
- Individual participant dataSharing planned: Yes. - The data available is Case-by-case basis at the discretion of Primary Sponsor
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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.
Ehab M Abd El Kafy, Ph.D principal investigator
Faculty of Applied Medical Sciences - Umm Al Qura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physical Therapy Protocol and TheraTog orthotic undergarment with its strapping system in people with Kyphosis, run by Umm Al-Qura University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 14 Oct 2021. 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 Saudi Arabia. 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?
Change in the thoracic kyphosis angle (°) (time frame: [Data was collected at baseline, and 12 weeks after intervention commencement.]). The study lists 4 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 14 Oct 2021; AzTrials last refreshed its copy on 6 Nov 2026.