Cerebral PalsyNCT04271618
Modulation of Sagittal Spinal Geometry in Children With Cerebral Palsy
A study testing TheraTogs Orthotic Undergarment in people with Cerebral Palsy, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial summary
The aim of this study will be to evaluate the the effect of Thera Togs soft orthotic undergarment on modulation of the spinal geometry and mobility in sagittal plan in children with spastic diplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- TheraTogs Orthotic Undergarment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 12 Feb 2020to 1 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Have a definite diagnosis of spastic diplegia obtained from medical files or personal physicians and supported by magnetic resonance images (MRIs).
- Their weight should be less than 40 kg.
- The degree of spasticity in the affected lower extremity will ranged between grades (1, 1+\&2) according to Modified Ashworth Scale.
- The levels of gross motor function will be selected at level II according to Gross Motor Function Classification System.
- The children will be included have the ability to stand alone for five minutes.
- Children should be able to understand and follow instructions.
- The degree of the spinal kyphosis ,for all participated children , in sagittal plane should be not more than 55° as Kyphosis above 55° is considered as fixed hyper-kyphosis while
Who cannot join
- Children with GMFCS levels III, IV, and V or use any assistive mobility devices
- Children suffering from allergic problems in their skin.
- Children with visual, auditory or cognitive deficits.
- Fixed and significant deformities of the lower limb and spine.
- Children with surgical interference for the lower limb and spine within the previous 2 years.
- Children with seizures.
- Children with fixed hyper-kyphosis (kyphotic angle is more than 55°).
- Children who used any medications (e.g., steroids) that affect growth or body composition.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Maternity and Children Hospital
Mecca, Mecca Region, 149239
About this study
Official title: Modulation of Sagittal Spinal Geometry in Children With Cerebral Palsy: Randomized Controlled Trial
The aim of this study will be to evaluate the the effect of Thera Togs soft orthotic undergarment on modulation of the spinal geometry and mobility in sagittal plan in children with spastic diplegic cerebral palsy.
Read the detailed description
Forty children with spastic diplegic CP will be assigned and randomly distributed into two equall groups (A\& B). Control group (A) will receive conventional rehabilitation program for postural correction 2 hours/3 sessions' weekly/3 successive months. Study group (B) will receive conventional rehabilitation protocol as in group (A) plus wearing TheraTogs soft orthotic undergarment. Children evaluation will be carried out before and after the intervention programs to assess postural deviations using the Formetric system.
- Conditions
- Cerebral Palsy
- Being tested
- TheraTogs Orthotic Undergarment
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraTogs Orthotic UndergarmentOther
Strapping undergarment made from a lightweight, breathable fabric that is velcro sensitive. It consists of sleeveless vest (tank-Top), two shorts (Hipster) each with two thigh cuffs and limb cuffs
| Study group | Role | What they receive |
|---|---|---|
| Traditional Treatment Arm | Active comparator | Participants in this group will receive conventional rehabilitation program for postural correction 2 hours/3 sessions' weekly/3 successive months. Receives: Other: TheraTogs Orthotic Undergarment |
| TheraTogs Undergarment Arm | Experimental | Participants in this group will receive the same conventional rehabilitation program as in traditional group in addition to wearing of TheraTogs soft orthotic undergarment with strapping system. Receives: Other: TheraTogs Orthotic Undergarment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Thoracic kyphotic angle at 3 months
Thoracic kyphotic angle will be calculated from the sagittal profile by Foremetric system.
Measured: Baseline and 3 months post-intervention
Change from baseline lumber lordotic angle at 3 months
Lumber lordotic angle will be calculated from the sagittal profile by Foremetric system.
Measured: Baseline and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start12 Feb 2020
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, 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, Shamekh Mohamed El-Shamy, Umm Al-Qura University
- Investigators
- Shamekh M El-Shamy, Ph.D., Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271618
- Sponsor's protocol ID
- Umm Al-Qura U
- Status last verified
- Feb 2020
- First submitted
- 12 Feb 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Sagittal Spinal Geometry in Children With Cerebral Palsy: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04271618
- Acronym / sponsor ID
- Umm Al-Qura U
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 17 Feb 2020 (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 this study will be to evaluate the the effect of Thera Togs soft orthotic undergarment on modulation of the spinal geometry and mobility in sagittal plan in children with spastic diplegic cerebral palsy.
Detailed description
Forty children with spastic diplegic CP will be assigned and randomly distributed into two equall groups (A\& B). Control group (A) will receive conventional rehabilitation program for postural correction 2 hours/3 sessions' weekly/3 successive months. Study group (B) will receive conventional rehabilitation protocol as in group (A) plus wearing TheraTogs soft orthotic undergarment. Children evaluation will be carried out before and after the intervention programs to assess postural deviations using the Formetric system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Treatment Arm | Active comparator | Other: TheraTogs Orthotic UndergarmentParticipants in this group will receive conventional rehabilitation program for postural correction 2 hours/3 sessions' weekly/3 successive months. |
| TheraTogs Undergarment Arm | Experimental | Other: TheraTogs Orthotic UndergarmentParticipants in this group will receive the same conventional rehabilitation program as in traditional group in addition to wearing of TheraTogs soft orthotic undergarment with strapping system. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Have a definite diagnosis of spastic diplegia obtained from medical files or personal physicians and supported by magnetic resonance images (MRIs).
- Their weight should be less than 40 kg.
- The degree of spasticity in the affected lower extremity will ranged between grades (1, 1+\&2) according to Modified Ashworth Scale.
- The levels of gross motor function will be selected at level II according to Gross Motor Function Classification System.
- The children will be included have the ability to stand alone for five minutes.
Key exclusion criteria (8 listed)
- Children with GMFCS levels III, IV, and V or use any assistive mobility devices
- Children suffering from allergic problems in their skin.
- Children with visual, auditory or cognitive deficits.
- Fixed and significant deformities of the lower limb and spine.
- Children with surgical interference for the lower limb and spine within the previous 2 years.
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 |
|---|---|---|
| TheraTogs Orthotic UndergarmentStrapping undergarment made from a lightweight, breathable fabric that is velcro sensitive. It consists of sleeveless vest (tank-Top), two shorts (Hipster) each with two thigh cuffs and limb cuffs | Other | TheraTogs Undergarment Arm, Traditional Treatment Arm |
Primary outcome
Change from baseline Thoracic kyphotic angle at 3 months
Time frame: Baseline and 3 months post-intervention
Thoracic kyphotic angle will be calculated from the sagittal profile by Foremetric system.
Change from baseline lumber lordotic angle at 3 months
Time frame: Baseline and 3 months post-intervention
Lumber lordotic angle will be calculated from the sagittal profile by Foremetric system.
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 28 Apr 2021.
- 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.
Shamekh M El-Shamy, Ph.D. principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraTogs Orthotic Undergarment in people with Cerebral Palsy, 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?
The sponsor lists 7 inclusion and 8 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 28 Apr 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 from baseline Thoracic kyphotic angle at 3 months (time frame: Baseline and 3 months post-intervention). The study lists 2 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 28 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.