Cerebral PalsyNCT04997044
Effect of Designed Physical Training After Selective Dorsal Rhizotomy on Motor Function of Ambulant Children With Spastic Diplegia
A study testing Concomitant physical rehabilitation, Standard Orthotic Management and selective dorsal rhizotomy in people with Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
The management of cerebral palsy is complex and requires a multidisciplinary approach. Selective dorsal rhizotomy is a neurosurgical technique that aims to reduce spasticity in the lower limbs and improve motor function. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Concomitant physical rehabilitation, Standard Orthotic Management and selective dorsal rhizotomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2020to 30 Jun 2022
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- CP, spastic diplegia
- 4-8 years of age
- The ability to walk with or without assistive devices typically on Level II-III on Gross Motor Function Classification System
- At least six months after the last Botulinum toxin A injection in the lower extremities
- Average intelligent quotient according to medical records for active participation
- Good trunk control with good antigravity strength of lower extremity on clinical examination.
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- Exclusionary criteria
- Ankle clonus; exaggerated deep tendon reflex in the legs
- Babinski sign
- Structural non-reducible deformities or musculoskeletal surgery in the lower extremities in the past 12 months
- Moderate to severe signs of dystonia, athetosis or ataxia.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study Investigating the Effect of Designed Physical Training After Selective Dorsal Rhizotomy on Motor Function of Ambulant Children With Spastic Diplegia
The management of cerebral palsy is complex and requires a multidisciplinary approach. Selective dorsal rhizotomy is a neurosurgical technique that aims to reduce spasticity in the lower limbs and improve motor function.
Read the detailed description
the current study is designed to assess the effectiveness of Selective dorsal rhizotomy on motor function in ambulant children with spastic diplegia. therefore, A convenient sample of ambulant children with spastic diplegia will be allocated to two groups of equal numbers (control and experimental)
- Conditions
- Cerebral Palsy
- Being tested
- Concomitant physical rehabilitation, Standard Orthotic Management, selective dorsal rhizotomy
- Keywords
- standard orthotic management, Selective dorsal rhizotomy, Bilateral Cerebral Palsy, Functional balance, Energy Cost of Walking, Functional capacity, Selective voluntary motor control:
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concomitant physical rehabilitationOther
Children of this group will receive a regular exercise rehabilitation program including starching exercises, functional strength training and static and dynamic balance exercises.The program will be conducted by six licensed pediatric physical therapists for one hour/session, 3 times/week, and six successive months.
Standard Orthotic ManagementOther
A custom-made articulating ankle foot orthosis was prescribed with a hinge at the level of the medial malleolus extends distally to the tip of the toes and proximally on the posterior surface of the leg to about 5 cm below the knee and secured straps. It is fabricated to permit free ankle dorsiflexion and lock the plantar flexion at 0 dorsiflexion. The splinting schedule started gradually for 2 h/day in the first month, 4 h/day in the second month to the entire wake-up time of the day.
selective dorsal rhizotomyOther
The surgical procedures were tailored to each child according to preoperative assessment plan. All SDRs were performed by a single neurosurgeon through an osteoplastic laminotomy from L2 to L5 that left the facet joints intact.
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | control group Receives: Other: Concomitant physical rehabilitation; Other: Standard Orthotic Management |
| Experimental group | Experimental | selective dorsal rhizotomy group Receives: Other: Concomitant physical rehabilitation; 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.
Functional Balance
The pediatric balance scale was used to assess the child's functional performance with total score is 56 and higher score representing a better performance.
Measured: after 6 months and after 1 year (follow-up)
Gross motor function
The gross motor function measure-88 is used to evaluate the motor function with total score is 100 and higher scores representing a better performance.
Measured: after 6 months and after 1 year (follow-up)
Secondary outcomes (3)
Selective voluntary motor control
Selective motor control of lower extremity scale is used for assessment of motor control of the lower limb joints in children with spastic cerebral palsy with a maximum score of 20 points, 10 points for each limb.
Measured: after 6 months and after 1 year (follow-up)
Energy cost of walking
The energy expenditure index (beats/meter) can be calculated as; walking heart rate (beats/min) minus resting heart rate (beats/ min) on walking velocity (meters/min).
Measured: after 6 months and after 1 year (follow-up)
Functional capacity
The six-minute walking test is used to assess walking capacity in children with and without disabilities.
Measured: after 6 months and after 1 year (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start20 Oct 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 42 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 universitySara S Saad-Eldien, PhD, Principal investigator, Cairo university, faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997044
- Sponsor's protocol ID
- selective dorsal rhizotomy
- Status last verified
- Dec 2022
- First submitted
- 4 Aug 2021
- Last updated
- 7 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Investigating the Effect of Designed Physical Training After Selective Dorsal Rhizotomy on Motor Function of Ambulant Children With Spastic Diplegia
- ClinicalTrials.gov ID
- NCT04997044
- Acronym / sponsor ID
- selective dorsal rhizotomy
- Conditions
- Cerebral Palsy
- Keywords
- standard orthotic management, Selective dorsal rhizotomy, Bilateral Cerebral Palsy, Functional balance, Energy Cost of Walking, Functional capacity, Selective voluntary motor control:
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 9 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.
The management of cerebral palsy is complex and requires a multidisciplinary approach. Selective dorsal rhizotomy is a neurosurgical technique that aims to reduce spasticity in the lower limbs and improve motor function.
Detailed description
the current study is designed to assess the effectiveness of Selective dorsal rhizotomy on motor function in ambulant children with spastic diplegia. therefore, A convenient sample of ambulant children with spastic diplegia will be allocated to two groups of equal numbers (control and experimental)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: Concomitant physical rehabilitation, Other: Standard Orthotic Managementcontrol group |
| Experimental group | Experimental | Other: Concomitant physical rehabilitation, Other: Standard Orthotic Management, Other: selective dorsal rhizotomyselective dorsal rhizotomy group |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- CP, spastic diplegia
- 4-8 years of age
- The ability to walk with or without assistive devices typically on Level II-III on Gross Motor Function Classification System
- At least six months after the last Botulinum toxin A injection in the lower extremities
- Average intelligent quotient according to medical records for active participation
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Concomitant physical rehabilitationChildren of this group will receive a regular exercise rehabilitation program including starching exercises, functional strength training and static and dynamic balance exercises.The program will be conducted by six licensed pediatric physical therapists for one hour/session, 3 times/week, and six successive months. | Other | Experimental group, control group |
| Standard Orthotic ManagementA custom-made articulating ankle foot orthosis was prescribed with a hinge at the level of the medial malleolus extends distally to the tip of the toes and proximally on the posterior surface of the leg to about 5 cm below the knee and secured straps. It is fabricated to permit free ankle dorsiflexion and lock the plantar flexion at 0 dorsiflexion. The splinting schedule started gradually for 2 h/day in the first month, 4 h/day in the second month to the entire wake-up time of the day. | Other | Experimental group, control group |
| selective dorsal rhizotomyThe surgical procedures were tailored to each child according to preoperative assessment plan. All SDRs were performed by a single neurosurgeon through an osteoplastic laminotomy from L2 to L5 that left the facet joints intact. | Other | Experimental group |
Primary outcome
Functional Balance
Time frame: after 6 months and after 1 year (follow-up)
The pediatric balance scale was used to assess the child's functional performance with total score is 56 and higher score representing a better performance.
Gross motor function
Time frame: after 6 months and after 1 year (follow-up)
The gross motor function measure-88 is used to evaluate the motor function with total score is 100 and higher scores representing a better performance.
3 secondary outcomes
Selective voluntary motor control
Time frame: after 6 months and after 1 year (follow-up)
Energy cost of walking
Time frame: after 6 months and after 1 year (follow-up)
Functional capacity
Time frame: after 6 months and after 1 year (follow-up)
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 Dec 2022.
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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
Sara S Saad-Eldien, PhD principal investigator
Cairo university, faculty of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concomitant physical rehabilitation, Standard Orthotic Management and selective dorsal rhizotomy 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 11 inclusion and 0 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 Dec 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?
Functional Balance (time frame: after 6 months and after 1 year (follow-up)). 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 7 Dec 2022.