Genu RecurvatumNCT07008521
UNIVERSAL EXERCISE UNIT and REBOUND THERAPY ON GENU RECURVATUM Cerebral Palsy Childeren
A study testing Universal exercise unit, Rebound Therapy and Traditional physical therapy program in people with Genu Recurvatum, run by Cairo University at 1 site in Egypt.
Trial summary
to investigate and compare between effectiveness of Universal Exercise Unit and Rebound Therapy on genu recurvatum, muscle strength, balance, functional mobility and quality of life in spastic cerebral palsy children Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Genu Recurvatum
- What is being tested?
- Universal exercise unit, Rebound Therapy 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
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 1 Oct 2025
- 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 5 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -Children with spastic CP both hemiplegic and diplegic.
- Their ages will be ranged from 5-7 years old.
- They will have mild spasticity (grade 1 and 1+) according to Modified Ashworth scale .
- They will be in level I and II according to gross motor function classification system (GMFCS) .
- They will be able to understand orders given to them.
Who cannot join
- Subjects will be excluded if they have the following:
- Visual or hearing impairment.
- Severe limb deformities as structural genurecurvatum.
- Surgical interference in the lower limbs for the last 6 months.
- Botulinum toxin injection of the spastic lower limb muscles during the last six months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECT OF UNIVERSAL EXERCISE UNIT VERSUS REBOUND THERAPY ON GENU RECURVATUM IN CHILDREN WITH SPASTIC CEREBRAL PALSY
to investigate and compare between effectiveness of Universal Exercise Unit and Rebound Therapy on genu recurvatum, muscle strength, balance, functional mobility and quality of life in spastic cerebral palsy children
Read the detailed description
Children will be equally assigned into three groups using simple randomization, control group, study group (A) and study group (B). Each group will consist of 20 children with spastic CP to overcome any drop out may occur.
Control group: Children in this group will receive a traditional physical therapy program.
Study group (A): Children in this group will receive a traditional physical therapy program in addition to universal exercise unit program.
Study group (B): Children in this group will receive the same traditional physical therapy program in addition to rebound therapy.
Evaluation will be carried out for each child individually before and after 3 months of treatment.
- Conditions
- Genu Recurvatum
- Being tested
- Universal exercise unit, Rebound Therapy, Traditional physical therapy program
- Keywords
- genu recurvatum, Cerebral Palsy, Universal Exercise Unit, Rebound Therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal exercise unitProcedure or surgery
universal exercise unit (UEU) for study groip (A)
Rebound TherapyProcedure or surgery
rebound therpay for study group (B)
Traditional physical therapy programProcedure or surgery
traditional physical therapy program for contrl group
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Control group: Children in this group will receive a traditional physical therapy program. Receives: Procedure: Traditional physical therapy program |
| study group A | Experimental | Study group (A): Children in this group will receive a traditional physical therapy program in addition to universal exercise unit program. Receives: Procedure: Universal exercise unit |
| Study group B | Experimental | Study group (B): Children in this group will receive the same traditional physical therapy program in addition to rebound therapy Receives: Procedure: Rebound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of genu recurvatum
degree of genu recurvatum will be measured by Radiological X-Ray
Measured: 10 minutes
Secondary outcomes (4)
muscle power
muscle power will be assessed by using Lafayette Manual Muscle Tester
Measured: 2 minutes
balance
Balance will be assessed by Pediatric Balance Scale
Measured: 20 minutes
functional mobility
Functional mobility will be assessed by Mobility Questionnaire (Mob Quest 28 )
Measured: 20 minutes
Quality of child life
Quality of life will be assessed by using Pediatric Quality of Life Inventory (PedsQL) scale
Measured: 20 minutes administration for each child
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Mar 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genu RecurvatumStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merhan Megahid Hamouda Bakr, Cairo University
- Investigators
- Nanees Essam Mohamed, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008521
- Sponsor's protocol ID
- 012005355
- Status last verified
- Aug 2024
- First submitted
- 29 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- 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 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF UNIVERSAL EXERCISE UNIT VERSUS REBOUND THERAPY ON GENU RECURVATUM IN CHILDREN WITH SPASTIC CEREBRAL PALSY
- ClinicalTrials.gov ID
- NCT07008521
- Acronym / sponsor ID
- 012005355
- Conditions
- Genu Recurvatum
- Keywords
- genu recurvatum, Cerebral Palsy, Universal Exercise Unit, Rebound Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 6 Jun 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.
to investigate and compare between effectiveness of Universal Exercise Unit and Rebound Therapy on genu recurvatum, muscle strength, balance, functional mobility and quality of life in spastic cerebral palsy children
Detailed description
Children will be equally assigned into three groups using simple randomization, control group, study group (A) and study group (B). Each group will consist of 20 children with spastic CP to overcome any drop out may occur.
Control group: Children in this group will receive a traditional physical therapy program.
Study group (A): Children in this group will receive a traditional physical therapy program in addition to universal exercise unit program.
Study group (B): Children in this group will receive the same traditional physical therapy program in addition to rebound therapy.
Evaluation will be carried out for each child individually before and after 3 months of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: Traditional physical therapy programControl group: Children in this group will receive a traditional physical therapy program. |
| study group A | Experimental | Procedure: Universal exercise unitStudy group (A): Children in this group will receive a traditional physical therapy program in addition to universal exercise unit program. |
| Study group B | Experimental | Procedure: Rebound TherapyStudy group (B): Children in this group will receive the same traditional physical therapy program in addition to rebound therapy |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- -Children with spastic CP both hemiplegic and diplegic.
- Their ages will be ranged from 5-7 years old.
- They will have mild spasticity (grade 1 and 1+) according to Modified Ashworth scale .
- They will be in level I and II according to gross motor function classification system (GMFCS) .
- They will be able to understand orders given to them.
Key exclusion criteria (5 listed)
- Subjects will be excluded if they have the following:
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 |
|---|---|---|
| Universal exercise unituniversal exercise unit (UEU) for study groip (A) | Procedure or surgery | study group A |
| Rebound Therapyrebound therpay for study group (B) | Procedure or surgery | Study group B |
| Traditional physical therapy programtraditional physical therapy program for contrl group | Procedure or surgery | control group |
Primary outcome
degree of genu recurvatum
Time frame: 10 minutes
degree of genu recurvatum will be measured by Radiological X-Ray
4 secondary outcomes
muscle power
Time frame: 2 minutes
balance
Time frame: 20 minutes
functional mobility
Time frame: 20 minutes
Quality of child life
Time frame: 20 minutes administration for each child
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Genu Recurvatum
Recruiting
Engaging Kids With Robotic Exoskeletons and Gamification
Genu Recurvatum, Crouch Gait
Enrolling by invitation
Comparison of Open Vs Closed Kinetic Chain Exercises in Genu Recurvatum Among Stroke Patients
Cerebrovascular Accident (Stroke), Knee Hyperextension
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.
Nanees Essam Mohamed, PhD 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 Universal exercise unit, Rebound Therapy and Traditional physical therapy program in people with Genu Recurvatum, 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 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?
Results are not available in the source record.
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?
degree of genu recurvatum (time frame: 10 minutes). 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 6 Jun 2025.