Cerebral PalsyNCT06646718
Effect Of Closed Kinetic Chain On Hip Stability In Spastic Cerebral Palsy Post Selective Dorsal Rhizotomy
A study testing Close kinetic chain exercise group and Traditional physical therapy. in people with Cerebral Palsy and Selective Dorsal Rhizotomy, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Purpose of the study: To evaluate the effect of closed kinetic chain on hip stability after selective dorsal rhizotomy on spastic cerebral palsy. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Cerebral Palsy, Selective Dorsal Rhizotomy
- What is being tested?
- Close kinetic chain exercise group and Traditional physical therapy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2024to 20 Oct 2024
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1-Patients will be aged from 5 to 14 years
- 2- will be included both genders post selective dorsal rhizotomy.
- 3- The GMFCS level I-II spastic diplegia, able to stand up from a chair independently and maintain standing for more than 5 seconds without falling.
- 4- Had not received any strength training program in the past 3 months before the study.
- 5- Able to attend physical therapy (PT) treatment at least three a week before and during this study.
Who cannot join
- 1-have perceptual, cognitive, visual and auditory disorder.
- 2- botulinum toxin injection to the lower extremities within 6 Months.
- 3- Medical conditions that prevented children from participating in the exercises.
- 4- Previous lower extremity surgery, such as prior hamstring muscle Lengthening. 5- Existence of any orthopedic condition or any static hip, knee or ankle deformities.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of physical therapy, Kafr elsheikh University
Kafr ash Shaykh, Kafr Elsheikh
About this study
Purpose of the study:
To evaluate the effect of closed kinetic chain on hip stability after selective dorsal rhizotomy on spastic cerebral palsy.
Read the detailed description
- This is a prospective randomized controlled clinical trial, conducted at Kafr El sheikh Hospital.
- Sixty-six children of both genders.
- The study will include children (age 5-14years) post selective dorsal rhizotomy.
- Children meeting the inclusion criteria will be randomly assigned to one of two groups:
- Experimental Group: children in this group will receive closed kinetic chain.
- Control Group: Patients in this group will receive Traditional physical therapy.
- Randomization will be achieved using computer-generated random numbers to ensure an equal distribution of patients between the two groups.
- Conditions
- Cerebral Palsy, Selective Dorsal Rhizotomy
- Being tested
- Close kinetic chain exercise group, Traditional physical 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.
Close kinetic chain exercise groupProcedure or surgery
Also called Experimental group intervention
●Close kinetic chain exercise group: group A will receive forward step-ups, lateral step-ups, squats, sit-to-stand, and stoop-and-recover exercises. session will be initiated with a 10 min warm-up period, including stretching of the major muscles and muscle groups, then 40 min different exercises and terminated with a 10 min cool-down period in the form of aerobic exercises.
Traditional physical therapy.Procedure or surgery
Also called Control group intervention
●Traditional physiotherapy: group B will receive stretching for the lower extremity muscles, namely hip flexors and adductors, hamstrings, and calf muscles; and strengthening exercises for core muscles, hip extensors, flexors and abductors, internal and external rotators of the hip, flexors and extensors of the knee, ankle dorsi flexors, kneeling exercises, and standing and gait training
| Study group | Role | What they receive |
|---|---|---|
| ❖ Experimental Group: group A | Experimental | Group A (study group): will include 33 children after selective dorsal rhizotomy surgery from both gender will be selected from the Outpatient Clinic. Able to attend physical therapy (PT) treatment at least three a week before and during this study. who will receive closed kinetic chain. Receives: Procedure: Close kinetic chain exercise group |
| ❖ Control Group:Group B | Other | ●Group B (control group): will include 33 children who will receive Traditional physiotherapy. will include 33 children after selective dorsal rhizotomy surgery from both gender Receives: Procedure: Traditional physical therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic dynamometry:
Isokinetic dynamometry testing is a device used within sports and exercise science as well as clinical testing environments that is used to evaluate joint torque. Isokinetic dynamometers are able to test the strength (torque) and power of different muscle groups.
is a safe and reliable method accepted as the "gold standard" in the evaluation of muscle strength.
It will be used before and after intervention to measure muscle strength
Measured: 12 weeks
X-ray:
used to assess the alignment of the hip joint, detect any abnormalities, and determine the degree of bone deformities or hip dislocation.
Will be used before and after intervention to determine hip angles
Measured: 12 weeks
The Pediatric Balance Scale:
The Pediatric Balance Scale (PBS), which is a modification of Berg Balance Scale (BBS) designed for children and adolescents aged 5 to 15 years, to assess functional balance abilities. The scale is composed of 14 items that are scored on a criterion-based 0 to 4 scale. The range of scores in the PBS is 0 to 56. each activity is rated on a five-point scale (0-4) so that the maximum score is 56. Patients who score 41 or higher are considered to be a low fall risk, those who score between 21 and 40 are considered to be moderate fall risks, and those who score below 20 are considered to be high fall risks. It will be completed in 15-20 minutes
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start30 Jan 2024
- Primary completion12 Oct 2024 (estimated)
- Study completion20 Oct 2024 (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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * The study will include children (age 5-14years) post selective dorsal rhizotomy. * Children meeting the inclusion criteria will be randomly assigned to one of two groups: * Experimental Group: children in this group will receive closed kinetic chain. * Control Group: Patients in this group will receive Traditional physical therapy.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaza Salah Eldin Ahmed Mostafa Elabd, Kafrelsheikh University
- Investigators
- Abdelaziz Ali Sherief, Professor, Study director, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646718
- Sponsor's protocol ID
- KFSIRB200-171
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 17 Oct 2024
- 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 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Closed Kinetic Chain On Hip Stability In Spastic Cerebral Palsy Post Selective Dorsal Rhizotomy
- ClinicalTrials.gov ID
- NCT06646718
- Acronym / sponsor ID
- KFSIRB200-171
- Conditions
- Cerebral Palsy, Selective Dorsal Rhizotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 12 Oct 2024 (estimated)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 17 Oct 2024 (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 the effect of closed kinetic chain on hip stability after selective dorsal rhizotomy on spastic cerebral palsy.
Detailed description
- This is a prospective randomized controlled clinical trial, conducted at Kafr El sheikh Hospital.
- Sixty-six children of both genders.
- The study will include children (age 5-14years) post selective dorsal rhizotomy.
- Children meeting the inclusion criteria will be randomly assigned to one of two groups:
- Experimental Group: children in this group will receive closed kinetic chain.
- Control Group: Patients in this group will receive Traditional physical therapy.
- Randomization will be achieved using computer-generated random numbers to ensure an equal distribution of patients between the two groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * The study will include children (age 5-14years) post selective dorsal rhizotomy. * Children meeting the inclusion criteria will be randomly assigned to one of two groups: * Experimental Group: children in this group will receive closed kinetic chain. * Control Group: Patients in this group will receive Traditional physical therapy.
| Arm | Type | Receives |
|---|---|---|
| ❖ Experimental Group: group A | Experimental | Procedure: Close kinetic chain exercise groupGroup A (study group): will include 33 children after selective dorsal rhizotomy surgery from both gender will be selected from the Outpatient Clinic. Able to attend physical therapy (PT) treatment at least three a week before and during this study. who will receive closed kinetic chain. |
| ❖ Control Group:Group B | Other | Procedure: Traditional physical therapy.●Group B (control group): will include 33 children who will receive Traditional physiotherapy. will include 33 children after selective dorsal rhizotomy surgery from both gender |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 1-Patients will be aged from 5 to 14 years
- 2- will be included both genders post selective dorsal rhizotomy.
- 3- The GMFCS level I-II spastic diplegia, able to stand up from a chair independently and maintain standing for more than 5 seconds without falling.
- 4- Had not received any strength training program in the past 3 months before the study.
- 5- Able to attend physical therapy (PT) treatment at least three a week before and during this study.
Key exclusion criteria (4 listed)
- 1-have perceptual, cognitive, visual and auditory disorder.
- 2- botulinum toxin injection to the lower extremities within 6 Months.
- 3- Medical conditions that prevented children from participating in the exercises.
- 4- Previous lower extremity surgery, such as prior hamstring muscle Lengthening. 5- Existence of any orthopedic condition or any static hip, knee or ankle 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 |
|---|---|---|
| Close kinetic chain exercise groupAlso: Experimental group intervention●Close kinetic chain exercise group: group A will receive forward step-ups, lateral step-ups, squats, sit-to-stand, and stoop-and-recover exercises. session will be initiated with a 10 min warm-up period, including stretching of the major muscles and muscle groups, then 40 min different exercises and terminated with a 10 min cool-down period in the form of aerobic exercises. | Procedure or surgery | ❖ Experimental Group: group A |
| Traditional physical therapy.Also: Control group intervention●Traditional physiotherapy: group B will receive stretching for the lower extremity muscles, namely hip flexors and adductors, hamstrings, and calf muscles; and strengthening exercises for core muscles, hip extensors, flexors and abductors, internal and external rotators of the hip, flexors and extensors of the knee, ankle dorsi flexors, kneeling exercises, and standing and gait training | Procedure or surgery | ❖ Control Group:Group B |
Primary outcome
Isokinetic dynamometry:
Time frame: 12 weeks
Isokinetic dynamometry testing is a device used within sports and exercise science as well as clinical testing environments that is used to evaluate joint torque. Isokinetic dynamometers are able to test the strength (torque) and power of different muscle groups. is a safe and reliable method accepted as the "gold standard" in the evaluation of muscle strength. It will be used before and after intervention to measure muscle strength
X-ray:
Time frame: 12 weeks
used to assess the alignment of the hip joint, detect any abnormalities, and determine the degree of bone deformities or hip dislocation. Will be used before and after intervention to determine hip angles
The Pediatric Balance Scale:
Time frame: 12 weeks
The Pediatric Balance Scale (PBS), which is a modification of Berg Balance Scale (BBS) designed for children and adolescents aged 5 to 15 years, to assess functional balance abilities. The scale is composed of 14 items that are scored on a criterion-based 0 to 4 scale. The range of scores in the PBS is 0 to 56. each activity is rated on a five-point scale (0-4) so that the maximum score is 56. Patients who score 41 or higher are considered to be a low fall risk, those who score between 21 and 40 are considered to be moderate fall risks, and those who score below 20 are considered to be high fall risks. It will be completed in 15-20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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.
Abdelaziz Ali Sherief, Professor study director
Kafrelsheikh 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 Close kinetic chain exercise group and Traditional physical therapy. in people with Cerebral Palsy and Selective Dorsal Rhizotomy, 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 4 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 17 Oct 2024. 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?
Isokinetic dynamometry: (time frame: 12 weeks). The study lists 3 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 17 Oct 2024.