Cerebral PalsyNCT05316090
Effect of Core Stability Excercises Program on Reaching in Children With Cerebral Palsy
A study testing Core stability exercises program and Traditional physical therapy program in people with Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
Purpose of the study: To evaluate effect of core stability exercises program on upper limb reaching in children with spastic hemiparetic cerebral palsy. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Core stability exercises program and Traditional physical therapy program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Feb 2021to 8 Aug 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The age of the selected children ranged from 3 To 6 years old.
- Degree of spasticity is ranging from 1 to 1+, according to modified Ashworth scale(Bohannon and Smith, 1987).
- Children with hemiparetic cerebral palsy
Who cannot join
- 1. Fructures and fixed deformities
Trial locations and contacts
1 site in 1 country.
About this study
Purpose of the study:
To evaluate effect of core stability exercises program on upper limb reaching in children with spastic hemiparetic cerebral palsy.
Read the detailed description
Thirty spastic hemiparetic cerebral palsied children of both sexes will be selected from General hospitals and private centers in El-Minia government with the following criteria:
- The age of the selected children ranged from 3 To 6 years old.
- Degree of spasticity is ranging from 1 to 1+, according to modified Ashworth scale
- Children in study group will be treated using core stability exercises program in addition to traditional program and children in the control group will be treated using traditional physical therapy program.
- Trunk control measurement scale and pediatric reach test will be used to evaluate each child individually before and after 6 successive weeks of treatment, three times per week.
- Conditions
- Cerebral Palsy
- Being tested
- Core stability exercises program, Traditional physical therapy program
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stability exercises programProcedure or surgery
Strengthening to the trunk muscles
Traditional physical therapy programProcedure or surgery
Neurodevelopmental training excercises
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Children in study group treated using core stability exercises program in addition to traditional program Receives: Procedure: Core stability exercises program; Procedure: Traditional physical therapy program |
| control group | Active comparator | Children in the control group treated using traditional physical therapy program. Receives: Procedure: Traditional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric reach test
Reaching score
Measured: assessment after 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start8 Feb 2021
- Primary completion1 Aug 2021
- Study completion8 Aug 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.
- 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
- Model description
- study group and control group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Elsayed Abbass, Cairo University
- Investigators
- Mai Abbass, Ph.D., Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316090
- Sponsor's protocol ID
- P.T.REC/012/003125
- Status last verified
- Mar 2022
- First submitted
- 23 Mar 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- 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 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Core Stability Excercises Program on Reaching in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05316090
- Acronym / sponsor ID
- P.T.REC/012/003125
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 8 Aug 2021 (actual)
- First posted
- 7 Apr 2022 (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.
Purpose of the study:
To evaluate effect of core stability exercises program on upper limb reaching in children with spastic hemiparetic cerebral palsy.
Detailed description
Thirty spastic hemiparetic cerebral palsied children of both sexes will be selected from General hospitals and private centers in El-Minia government with the following criteria:
- The age of the selected children ranged from 3 To 6 years old.
- Degree of spasticity is ranging from 1 to 1+, according to modified Ashworth scale
- Children in study group will be treated using core stability exercises program in addition to traditional program and children in the control group will be treated using traditional physical therapy program.
- Trunk control measurement scale and pediatric reach test will be used to evaluate each child individually before and after 6 successive weeks of treatment, three times per week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- study group and control group
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Procedure: Core stability exercises program, Procedure: Traditional physical therapy programChildren in study group treated using core stability exercises program in addition to traditional program |
| control group | Active comparator | Procedure: Traditional physical therapy programChildren in the control group treated using traditional physical therapy program. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The age of the selected children ranged from 3 To 6 years old.
- Degree of spasticity is ranging from 1 to 1+, according to modified Ashworth scale(Bohannon and Smith, 1987).
- Children with hemiparetic cerebral palsy
Key exclusion criteria (1 listed)
- 1. Fructures and fixed deformities
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 |
|---|---|---|
| Core stability exercises programStrengthening to the trunk muscles | Procedure or surgery | study group |
| Traditional physical therapy programNeurodevelopmental training excercises | Procedure or surgery | control group, study group |
Primary outcome
Pediatric reach test
Time frame: assessment after 6 weeks of intervention
Reaching score
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 7 Apr 2022.
- 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.
Mai Abbass, Ph.D. study director
Cairo 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 Core stability exercises program and Traditional physical therapy program in people with Cerebral Palsy, 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 3 inclusion and 1 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 7 Apr 2022. 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?
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?
Pediatric reach test (time frame: assessment after 6 weeks of intervention). 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 Apr 2022; AzTrials last refreshed its copy on 31 Oct 2026.