Serial CastingNCT07338162
Is Serial Casting a Valid Option for Management of Lower Limb Deformities in Patient With Spastic Cerebral Palsy?
A study testing Physical therapy program and Three consecutive casts + Physical therapy program in people with Serial Casting and Management, run by Cairo University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the effectiveness of serial casting as a modality of management of lower limb deformities in patients with spastic cerebral palsy (equinous - equinovarus). Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Serial Casting, Management, Lower Limb Deformities
- What is being tested?
- Physical therapy program and Three consecutive casts + Physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 1 Feb 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients from 3 to 12 years old.
- Both sex.
- Spastic cerebral palsy patients with true equinous.
- Modified Ashworth Scale score of 2 or 3 in the plantar flexor muscle complex.
- Gross Motor Functional Classification System Level I, II \& III.
Who cannot join
- Patients with bony joint limitation.
- Previous surgeries (tendon lengthening).
- Patients received Botulinum toxin A injections in the last six months.
- Patients with apparent equinus as a compensation for knee or hip flexion while dorsiflexion range is preserved at the lower extremity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Serial Casting a Valid Option for Management of Lower Limb Deformities in Patient With Spastic Cerebral Palsy (Equinus - Equinovarus)?
This study aimed to evaluate the effectiveness of serial casting as a modality of management of lower limb deformities in patients with spastic cerebral palsy (equinous - equinovarus).
Read the detailed description
Cerebral Palsy (CP) is classified as a group of postural and motor disorders caused by a non-progressive lesion to the developing brain, acquired before the age of two. Among the different types of CP, spastic CP is the most common form consisting of approximately 85.8% of diagnoses.
Current clinical management of spasticity and contracture in the lower limb includes conservative approaches such as the use of physiotherapy, orthoses, casting and splinting. Other commonly used invasive strategies for spasticity and contracture management include neurotoxin injections such as botulinum toxin A (BTX-A) and intrathecal baclofen, as well as surgery such as selective dorsal rhizotomy (SDR) and various corrective orthopaedic operations including tendon lengthening procedures and single-event multilevel surgeries (SEMLS).
- Being tested
- Physical therapy program, Three consecutive casts + 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.
Physical therapy programOther
Children with spastic cerebral palsy who is subjected to a selected physical therapy program once a day/3 times a week for three successive weeks mainly consisted of stretching and strengthening exercises, weight bearing, balance, proprioception, and ambulation training.
Three consecutive casts + Physical therapy programOther
Children with spastic cerebral palsy who is additionally subjected to three consecutive casts applied for five days each and will be removed in the last two days in each week to conduct the same selected physical therapy program.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Children with spastic cerebral palsy who is subjected to a selected physical therapy program once a day/3 times a week for three successive weeks mainly consisted of stretching and strengthening exercises, weight bearing, balance, proprioception, and ambulation training. Receives: Other: Physical therapy program |
| Group B | Experimental | Children with spastic cerebral palsy who is additionally subjected to three consecutive casts applied for five days each and will be removed in the last two days in each week to conduct the same selected physical therapy program. Receives: Other: Three consecutive casts + Physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of ankle range of motion
Ankle range of motion was assessed.
Measured: 3 months after the procedure
Secondary outcomes (4)
Tone of the calf muscle
Tone of the calf muscle was measured.
Measured: 3 months after the procedure
Detection of ankle kinematics during gait
The children will be instructed to walk and videos were taken from the side, only five sections were tested to evaluate ankle kinematics and knee position in relation to ankle (initial foot contact, foot contact at mid stance, timing of heel rise, knee position in mid stance, degree of change) with a total score of 14 on each limb.
Measured: 3 months after the procedure
Incidence of true equinous in patients with spastic cerebral palsy
Incidence of true equinous in patients with spastic cerebral palsy was assessed.
Measured: 3 months after the procedure
Modified Ashworth Scale (MAS) score
The Modified Ashworth Scale (MAS) score is a widely used measurement tool, and it is scored as follows: 0, no increase in muscle tone; 1, slight increase in muscle tone at the end of the range of motion; 2, slight increase in muscle tone through less than half of the range of motion; 3, more marked increase in muscle tone through most of the range of motion; 4, considerable increase in muscle tone; and 5, joint is rigid.
Measured: 3 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Oct 2022
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serial CastingStudies 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abdou Mohamed Dawood, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338162
- Sponsor's protocol ID
- MD-97-2023
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Serial Casting a Valid Option for Management of Lower Limb Deformities in Patient With Spastic Cerebral Palsy (Equinus - Equinovarus)?
- ClinicalTrials.gov ID
- NCT07338162
- Acronym / sponsor ID
- MD-97-2023
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 13 Jan 2026 (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.
This study aimed to evaluate the effectiveness of serial casting as a modality of management of lower limb deformities in patients with spastic cerebral palsy (equinous - equinovarus).
Detailed description
Cerebral Palsy (CP) is classified as a group of postural and motor disorders caused by a non-progressive lesion to the developing brain, acquired before the age of two. Among the different types of CP, spastic CP is the most common form consisting of approximately 85.8% of diagnoses.
Current clinical management of spasticity and contracture in the lower limb includes conservative approaches such as the use of physiotherapy, orthoses, casting and splinting. Other commonly used invasive strategies for spasticity and contracture management include neurotoxin injections such as botulinum toxin A (BTX-A) and intrathecal baclofen, as well as surgery such as selective dorsal rhizotomy (SDR) and various corrective orthopaedic operations including tendon lengthening procedures and single-event multilevel surgeries (SEMLS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Physical therapy programChildren with spastic cerebral palsy who is subjected to a selected physical therapy program once a day/3 times a week for three successive weeks mainly consisted of stretching and strengthening exercises, weight bearing, balance, proprioception, and ambulation training. |
| Group B | Experimental | Other: Three consecutive casts + Physical therapy programChildren with spastic cerebral palsy who is additionally subjected to three consecutive casts applied for five days each and will be removed in the last two days in each week to conduct the same selected physical therapy program. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients from 3 to 12 years old.
- Both sex.
- Spastic cerebral palsy patients with true equinous.
- Modified Ashworth Scale score of 2 or 3 in the plantar flexor muscle complex.
- Gross Motor Functional Classification System Level I, II \& III.
Key exclusion criteria (4 listed)
- Patients with bony joint limitation.
- Previous surgeries (tendon lengthening).
- Patients received Botulinum toxin A injections in the last six months.
- Patients with apparent equinus as a compensation for knee or hip flexion while dorsiflexion range is preserved at the lower extremity.
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 programChildren with spastic cerebral palsy who is subjected to a selected physical therapy program once a day/3 times a week for three successive weeks mainly consisted of stretching and strengthening exercises, weight bearing, balance, proprioception, and ambulation training. | Other | Group A |
| Three consecutive casts + Physical therapy programChildren with spastic cerebral palsy who is additionally subjected to three consecutive casts applied for five days each and will be removed in the last two days in each week to conduct the same selected physical therapy program. | Other | Group B |
Primary outcome
Evaluation of ankle range of motion
Time frame: 3 months after the procedure
Ankle range of motion was assessed.
4 secondary outcomes
Tone of the calf muscle
Time frame: 3 months after the procedure
Detection of ankle kinematics during gait
Time frame: 3 months after the procedure
Incidence of true equinous in patients with spastic cerebral palsy
Time frame: 3 months after the procedure
Modified Ashworth Scale (MAS) score
Time frame: 3 months after the procedure
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 13 Jan 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 program and Three consecutive casts + Physical therapy program in people with Serial Casting and Management, 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 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: finished, as of the sponsor's last update on 13 Jan 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?
Evaluation of ankle range of motion (time frame: 3 months after the procedure). 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 13 Jan 2026.