Bilateral Cerebral PalsyNCT05006144
Effects of Physical Training Following Selective Dorsal Rhizotomy on Non-ambulant Children With Bilateral Spastic Cerebral Palsy
A study testing physical therapy excercises, Standard Orthotic Management and selective dorsal rhizotomy in people with Bilateral Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
Children with spastic bilateral cerebral palsy are late developers. delayed gross and fine motor development require early intervention to improve the child performance and avoid secondary impairments. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Bilateral Cerebral Palsy
- What is being tested?
- physical therapy excercises, Standard Orthotic Management and selective dorsal rhizotomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2022to 24 Dec 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 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- CP, spastic diplegia
- 4-7 years of age
- On Level IV-V on Gross Motor Function Classification System
- Partial trunk control (sitting with support).
Who cannot join
- Structural non-reducible deformities or musculoskeletal surgery in the lower extremities in the past 12 months
- Ankle clonus
- Exaggerated deep tendon reflex in the legs
- Babinski sign;
- Moderate to severe signs of dystonia, athetosis or ataxia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Physical Training Following Selective Dorsal Rhizotomy on Trunk Control, Selectivity and Upper Extremity Function of Non-ambulant Children With Bilateral Spastic Cerebral Palsy: A Randomized Controlled Trial
Children with spastic bilateral cerebral palsy are late developers. delayed gross and fine motor development require early intervention to improve the child performance and avoid secondary impairments.
Read the detailed description
increased tone of lower extremity muscles interfere with the child sitting posture and trunk control. delayed sitting and lack of trunk control contribute to the impairments of upper extremity functions.
selective dorsal rhizotomy is a surgical procedure to control increased tone of the lower extremities. Therefore, the current study is carried out to investigate the effects of selective dorsal rhizotomy on trunk control, selectivity and upper extremity function of non-ambulant children with bilateral spastic cerebral palsy
- Conditions
- Bilateral Cerebral Palsy
- Being tested
- physical therapy excercises, Standard Orthotic Management, selective dorsal rhizotomy
- Keywords
- Bilateral Cerebral Palsy, Selective dorsal rhizotomy, segmental trunk control, Motor development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapy excercisesOther
- Sequenced trunk co-activation exercises
- Righting and protective reactions
- Functional stretching exercises.
Standard Orthotic ManagementOther
A custom-made articulating ankle foot orthosis
selective dorsal rhizotomyOther
All SDRs were performed by a single neurosurgeon through an osteoplastic laminotomy from L2 to L5
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | control group Receives: Other: physical therapy excercises; Other: Standard Orthotic Management |
| SDR-group | Experimental | selective dorsal rhizotomy Receives: Other: physical therapy excercises; Other: Standard Orthotic Management; Other: selective dorsal rhizotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Segmental trunk control
The Segmental Assessment of Trunk Control is applied to assess upright trunk postural control in sitting position based on subdividing the trunk into 6 segments. The head/trunk control is acquired segment by segment if upright sitting posture can be maintained under three conditions including: static control at static position, active control while the child moves the head and/or arm and reactive control after external perturbation.The trunk segments according to the scale include: head/neck, thoracic (upper, mid and lower) and lumbar (upper and lower) segments. It is an ordinal scale with a grade 1 to 7 is assigned for each segment with the score 7 indicates that the infant can't retain independent sitting (no hand support). A score of 8 is given as full trunk control is gained.
Measured: period of the treatment was 4 successive months
Gross motor function
The gross motor function measure-88 is a valid and reliable criterion referenced instrument; is currently used to evaluate the motor function over time in individuals with cerebral palsy.
Measured: period of the treatment was 4 successive months
Secondary outcomes (1)
upper extremity function
The quality of upper extremity skill test is a reliable and valid tool used to measure the motor function in children with cerebral palsy ages of 18 months to 8 years. T
Measured: period of the treatment was 4 successive months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start10 Aug 2022
- Primary completion30 Jan 2024
- Study completion24 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mahmoud Abd-elmonem, Cairo University
- Investigators
- Hazem A Aly, Phd, Study chair, PhD of physical therapy for pediatrics, faculty of physical therapyCairo universityAhmed rabie, Phd, Study director, Department of neurosurgery, faculty of medicine , Alexandria university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006144
- Sponsor's protocol ID
- spastic cerebral palsy
- Status last verified
- Apr 2026
- First submitted
- 7 Aug 2021
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Training Following Selective Dorsal Rhizotomy on Trunk Control, Selectivity and Upper Extremity Function of Non-ambulant Children With Bilateral Spastic Cerebral Palsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05006144
- Acronym / sponsor ID
- spastic cerebral palsy
- Conditions
- Bilateral Cerebral Palsy
- Keywords
- Bilateral Cerebral Palsy, Selective dorsal rhizotomy, segmental trunk control, Motor development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 24 Dec 2025 (actual)
- First posted
- 16 Aug 2021 (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.
Children with spastic bilateral cerebral palsy are late developers. delayed gross and fine motor development require early intervention to improve the child performance and avoid secondary impairments.
Detailed description
increased tone of lower extremity muscles interfere with the child sitting posture and trunk control. delayed sitting and lack of trunk control contribute to the impairments of upper extremity functions.
selective dorsal rhizotomy is a surgical procedure to control increased tone of the lower extremities. Therefore, the current study is carried out to investigate the effects of selective dorsal rhizotomy on trunk control, selectivity and upper extremity function of non-ambulant children with bilateral spastic cerebral palsy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: physical therapy excercises, Other: Standard Orthotic Managementcontrol group |
| SDR-group | Experimental | Other: physical therapy excercises, Other: Standard Orthotic Management, Other: selective dorsal rhizotomyselective dorsal rhizotomy |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- CP, spastic diplegia
- 4-7 years of age
- On Level IV-V on Gross Motor Function Classification System
- Partial trunk control (sitting with support).
Key exclusion criteria (5 listed)
- Structural non-reducible deformities or musculoskeletal surgery in the lower extremities in the past 12 months
- Ankle clonus
- Exaggerated deep tendon reflex in the legs
- Babinski sign;
- Moderate to severe signs of dystonia, athetosis or ataxia.
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 |
|---|---|---|
| physical therapy excercises* Sequenced trunk co-activation exercises * Righting and protective reactions * Functional stretching exercises. | Other | SDR-group, control group |
| Standard Orthotic ManagementA custom-made articulating ankle foot orthosis | Other | SDR-group, control group |
| selective dorsal rhizotomyAll SDRs were performed by a single neurosurgeon through an osteoplastic laminotomy from L2 to L5 | Other | SDR-group |
Primary outcome
Segmental trunk control
Time frame: period of the treatment was 4 successive months
The Segmental Assessment of Trunk Control is applied to assess upright trunk postural control in sitting position based on subdividing the trunk into 6 segments. The head/trunk control is acquired segment by segment if upright sitting posture can be maintained under three conditions including: static control at static position, active control while the child moves the head and/or arm and reactive control after external perturbation.The trunk segments according to the scale include: head/neck, thoracic (upper, mid and lower) and lumbar (upper and lower) segments. It is an ordinal scale with a grade 1 to 7 is assigned for each segment with the score 7 indicates that the infant can't retain independent sitting (no hand support). A score of 8 is given as full trunk control is gained.
Gross motor function
Time frame: period of the treatment was 4 successive months
The gross motor function measure-88 is a valid and reliable criterion referenced instrument; is currently used to evaluate the motor function over time in individuals with cerebral palsy.
1 secondary outcome
upper extremity function
Time frame: period of the treatment was 4 successive months
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 28 Apr 2026.
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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.
Hazem A Aly, Phd study chair
PhD of physical therapy for pediatrics, faculty of physical therapyCairo university
Ahmed rabie, Phd study director
Department of neurosurgery, faculty of medicine , Alexandria 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 physical therapy excercises, Standard Orthotic Management and selective dorsal rhizotomy in people with Bilateral 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 4 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: finished, as of the sponsor's last update on 28 Apr 2026. 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?
Segmental trunk control (time frame: period of the treatment was 4 successive 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 28 Apr 2026.