Suit TherapyNCT07096531
Effectiveness of Suit Therapy With Dual Task Exercises on Gross Motor Functions and Walking in Children With Diplegic Cerebral Palsy
A study testing Suit therapy and Suit therapy + Dual-task exercises in people with Suit Therapy and Dual Task Exercises, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study aims to investigate the effect of suit therapy combined with dual-task training on gross motor performance and walking abilities in children with diplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Suit Therapy, Dual Task Exercises, Gross Motor Functions
- What is being tested?
- Suit therapy and Suit therapy + Dual-task exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 6 to 12 years.
- Both sexes.
- A medical diagnosis of spastic diplegic CP made by pediatricians or pediatric neurologists.
- Children with spasticity grades ranged from 1 to 2+ according to the Modified Ashworth scale (MAS).
- Children who can sit on the chair with good balance and recognize and follow verbal orders and commands are included in both testing and training techniques.
Who cannot join
- They had a permanent deformity (bony or soft tissue contractures).
- Children having visual or auditory defects.
- Current hospitalization for urgent medical reasons.
- Severe mental retardation.
- Children who will undergo fewer than twelve regular sessions of physical therapy at their place will not be included in the survey.
- Children with a history of epileptic seizure or any diagnosed cardiac or orthopedic disability that may hinder assessment methods and treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh
Waleed S Althobaiti, MBBCH, 0536164010, Walthubiti89@hotmail.com
Mohamed B Ibrahim, MD
About this study
Official title: The Effectiveness of Suit Therapy With Dual Task Exercises on Gross Motor Functions and Walking in Children With Diplegic Cerebral Palsy
This study aims to investigate the effect of suit therapy combined with dual-task training on gross motor performance and walking abilities in children with diplegic cerebral palsy.
Read the detailed description
Cerebral palsy (CP) is a non-progressive motor impairment syndrome caused by brain defects or lesions that occur in an immature brain before, during, or within two years after birth.
Therapeutic approaches for CP include neurodevelopmental treatment, Vojta therapy, sensory integration therapy, and conductive education. Specific therapeutic strategies for CP may differ, but they all aim to improve the independence of children with CP.
Suit therapy is a relatively new and experimental form of therapy designed to help those with cerebral palsy improve muscle tone, posture, and movements.
- Conditions
- Suit Therapy, Dual Task Exercises, Gross Motor Functions, Walking, Children, Diplegic Cerebral Palsy
- Being tested
- Suit therapy, Suit therapy + Dual-task exercises
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suit therapyOther
Patients will receive suit therapy.
Suit therapy + Dual-task exercisesOther
Patients will receive suit therapy in addition to dual-task exercises.
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Active comparator | Patients will receive suit therapy. Receives: Other: Suit therapy |
| Group (B) | Experimental | Patients will receive suit therapy in addition to dual-task exercises. Receives: Other: Suit therapy + Dual-task exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Gross Motor Function Measure 88 (GMFM-88)
The Gross Motor Function Measure (GMFM) 88 will be used to determine the severity of each case and to assess the child's motor performance in five dimensions: lying and rolling (17 items); sitting (20 items); crawling and kneeling (14 items); standing (13 items); and walking, running, and jumping (24 items). All items will be checked and scored before interpretation of the child's performance in each dimension. Scores of each dimension will be expressed as a percentage of the maximum scores for that dimension. The total score will be obtained by averaging the percentage scores across the five dimensions. Individual dimensions of GMFM-88 can be administered depending on the child's current level of function.
Measured: 3 months post-exercise
Secondary outcomes (1)
Evaluation of balance using the Pediatric Balance Scale (PBS)
The Pediatric Balance Scale (PBS) is a standardized tool for testing balance. The items can be measured within 15 minutes and do not require specialized equipment. The Pediatric Balance Scale is a modified version of the Berg Balance Scale, used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function), with a maximum score of 56 points
Measured: 3 months post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Oct 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suit TherapyStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Saleh Althobaiti, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096531
- Sponsor's protocol ID
- KFSIRB200-533
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Suit Therapy With Dual Task Exercises on Gross Motor Functions and Walking in Children With Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07096531
- Acronym / sponsor ID
- KFSIRB200-533
- Conditions
- Suit Therapy, Dual Task Exercises, Gross Motor Functions, Walking, Children, Diplegic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 31 Jul 2025 (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.
This study aims to investigate the effect of suit therapy combined with dual-task training on gross motor performance and walking abilities in children with diplegic cerebral palsy.
Detailed description
Cerebral palsy (CP) is a non-progressive motor impairment syndrome caused by brain defects or lesions that occur in an immature brain before, during, or within two years after birth.
Therapeutic approaches for CP include neurodevelopmental treatment, Vojta therapy, sensory integration therapy, and conductive education. Specific therapeutic strategies for CP may differ, but they all aim to improve the independence of children with CP.
Suit therapy is a relatively new and experimental form of therapy designed to help those with cerebral palsy improve muscle tone, posture, and movements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Active comparator | Other: Suit therapyPatients will receive suit therapy. |
| Group (B) | Experimental | Other: Suit therapy + Dual-task exercisesPatients will receive suit therapy in addition to dual-task exercises. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age from 6 to 12 years.
- Both sexes.
- A medical diagnosis of spastic diplegic CP made by pediatricians or pediatric neurologists.
- Children with spasticity grades ranged from 1 to 2+ according to the Modified Ashworth scale (MAS).
- Children who can sit on the chair with good balance and recognize and follow verbal orders and commands are included in both testing and training techniques.
Key exclusion criteria (6 listed)
- They had a permanent deformity (bony or soft tissue contractures).
- Children having visual or auditory defects.
- Current hospitalization for urgent medical reasons.
- Severe mental retardation.
- Children who will undergo fewer than twelve regular sessions of physical therapy at their place will not be included in the survey.
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 |
|---|---|---|
| Suit therapyPatients will receive suit therapy. | Other | Group (A) |
| Suit therapy + Dual-task exercisesPatients will receive suit therapy in addition to dual-task exercises. | Other | Group (B) |
Primary outcome
Evaluation of Gross Motor Function Measure 88 (GMFM-88)
Time frame: 3 months post-exercise
The Gross Motor Function Measure (GMFM) 88 will be used to determine the severity of each case and to assess the child's motor performance in five dimensions: lying and rolling (17 items); sitting (20 items); crawling and kneeling (14 items); standing (13 items); and walking, running, and jumping (24 items). All items will be checked and scored before interpretation of the child's performance in each dimension. Scores of each dimension will be expressed as a percentage of the maximum scores for that dimension. The total score will be obtained by averaging the percentage scores across the five dimensions. Individual dimensions of GMFM-88 can be administered depending on the child's current level of function.
1 secondary outcome
Evaluation of balance using the Pediatric Balance Scale (PBS)
Time frame: 3 months post-exercise
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suit therapy and Suit therapy + Dual-task exercises in people with Suit Therapy and Dual Task Exercises, run by Kafrelsheikh 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 31 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Waleed S Althobaiti, MBBCH (0536164010, Walthubiti89@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Gross Motor Function Measure 88 (GMFM-88) (time frame: 3 months post-exercise). 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 31 Jul 2025.