Cerebral PalsyNCT06927869
Pully System Exercise Role in Management of Spasticity
A study testing designed physical therapy , pully system exercise in people with Cerebral Palsy, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to investigate the effect of pully system exercise in in management of spasticity in cerebral palsy children Does pully system exercise has role in management of spasticity in cerebral palsy children ? Participants will: The participants assigned to the control group will receive a… Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- designed physical therapy , pully system exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2025to 1 Aug 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The degree of spasticity is (1) according to Modified Ashwarth's scale
- They able to understand orders given to them.
- All children evaluated before and after the suggested period of the physical therapy program (3months).
Who cannot join
- - No fixed deformities.
- They have neither visual nor auditory problems.
- They have neither perceptual nor cognitive problems.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Pully System Exercise in Management of Spasticity in Cerebral Palsy Children: A Randomized Clinical Trial
The goal of this clinical trial is to investigate the effect of pully system exercise in in management of spasticity in cerebral palsy children
Does pully system exercise has role in management of spasticity in cerebral palsy children ?
Participants will:
The participants assigned to the control group will receive a standard care program. This program is designed to provide basic supportive therapies without the specialized pulley system exercises
Read the detailed description
there are two groups one group will receive traditional physical therapy programme another group will receive pully system exercise
- Conditions
- Cerebral Palsy
- Being tested
- designed physical therapy , pully system exercise
- Keywords
- pully system, cerebral palsy, spasticity
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
designed physical therapy , pully system exerciseOther
Participants assigned to the intervention group will engage in a specially designed physical therapy program focusing on pulley system exercises. The program is scheduled to occur three times per week, which is frequent enough to potentially induce meaningful improvements while allowing adequate rest between sessions to prevent fatigue and overtraining
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | the l group will receive a standard care program. Receives: Other: designed physical therapy , pully system exercise |
| study | Experimental | study group will received pulley system exercises Receives: Other: designed physical therapy , pully system exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
gross motor function of children with cerebral palsy using GMFMS
evaluate change that occurs over time in the gross motor function of children with cerebral palsy
Measured: 3 months
pediatric balance scale
A 14-item criterion-referenced measure that examines functional balance in the context of everyday tasks in the pediatric population.
Measured: 3 months
Secondary outcomes (1)
spasticity with EMG
In assessing muscle tone it is important to consider all the inputs and outputs affecting it, using biomechanical-EMG techniques for measuring active tone
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start20 Apr 2025
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Yousef Abdel Elglil Yousef Elsebahy, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927869
- Sponsor's protocol ID
- KFSIRB200-193
- Status last verified
- Apr 2025
- First submitted
- 11 Feb 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pully System Exercise in Management of Spasticity in Cerebral Palsy Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06927869
- Acronym / sponsor ID
- KFSIRB200-193
- Conditions
- Cerebral Palsy
- Keywords
- pully system, cerebral palsy, spasticity
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 15 Apr 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.
The goal of this clinical trial is to investigate the effect of pully system exercise in in management of spasticity in cerebral palsy children
Does pully system exercise has role in management of spasticity in cerebral palsy children ?
Participants will:
The participants assigned to the control group will receive a standard care program. This program is designed to provide basic supportive therapies without the specialized pulley system exercises
Detailed description
there are two groups one group will receive traditional physical therapy programme another group will receive pully system exercise
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Other: designed physical therapy , pully system exercisethe l group will receive a standard care program. |
| study | Experimental | Other: designed physical therapy , pully system exercisestudy group will received pulley system exercises |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The degree of spasticity is (1) according to Modified Ashwarth's scale
- They able to understand orders given to them.
- All children evaluated before and after the suggested period of the physical therapy program (3months).
Key exclusion criteria (3 listed)
- - No fixed deformities.
- They have neither visual nor auditory problems.
- They have neither perceptual nor cognitive problems.
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 |
|---|---|---|
| designed physical therapy , pully system exerciseParticipants assigned to the intervention group will engage in a specially designed physical therapy program focusing on pulley system exercises. The program is scheduled to occur three times per week, which is frequent enough to potentially induce meaningful improvements while allowing adequate rest between sessions to prevent fatigue and overtraining | Other | group 1, study |
Primary outcome
gross motor function of children with cerebral palsy using GMFMS
Time frame: 3 months
evaluate change that occurs over time in the gross motor function of children with cerebral palsy
pediatric balance scale
Time frame: 3 months
A 14-item criterion-referenced measure that examines functional balance in the context of everyday tasks in the pediatric population.
1 secondary outcome
spasticity with EMG
Time frame: 3 months
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 25 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 designed physical therapy , pully system exercise in people with Cerebral Palsy, 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 3 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: enrolling by invitation, as of the sponsor's last update on 25 Jun 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?
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?
gross motor function of children with cerebral palsy using GMFMS (time frame: 3 months). 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 25 Jun 2025.