Cerebral PalsyNCT05294874
Gait Rehabilitation in Diplegic Children
A study testing gait training in people with Cerebral Palsy and Spastic Diplegia, run by Cairo University at 1 site in Egypt.
Trial summary
Background: Standing and walking serve an individual's basic need to move from place to place, and both are the most common activities that people do on a daily basis. Aim: to investigate the combined effect of botulinum toxin A (BoNT-A) injection and ankle weight on the gait of diplegic children who are using Ankle… Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Cerebral Palsy, Spastic Diplegia
- What is being tested?
- gait training
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2021to 25 Nov 2021
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosed as spastic diplegia.
- They were able to follow simple verbal instructions.
- The use of Ankle Foot Orthoses.
- Spasticity grade of 1+ or 2 in both calf and hamstring muscles according to modified Ashworth's scale (MAS).
- level I or II on the Gross Motor Function Classification System (GMFCS).
Who cannot join
- fixed contractures or deformities in the lower limbs.
- surgical orthopedic intervention.
- Botulinum A injection or use of neuromuscular blockers in the previous 6 months before the start of study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy,Cairo University
Cairo, Giza Governorate, 02
About this study
Official title: Gait Rehabilitation in Ambulant Diplegic Children Using BOTOX and Ankle Weights
Background: Standing and walking serve an individual's basic need to move from place to place, and both are the most common activities that people do on a daily basis.
Aim: to investigate the combined effect of botulinum toxin A (BoNT-A) injection and ankle weight on the gait of diplegic children who are using Ankle foot orthoses.
Read the detailed description
Methods: Sixty children with spastic diplegia were included in this prospective, controlled trial. Children were divided into three groups, each with 20 patients: Group 1 received classical gait rehabilitation; Group 2 received the same gait training while adding ankle weight ; and Group 3 received the same as group 2 plus botulinum toxin injection. The Modified Ashworth Scale (MAS),knee range-of-motion measures, and Hoffman /Myogenic reflex ratio were used to examine patients before the commencement of treatment and post-treatment.
- Conditions
- Cerebral Palsy, Spastic Diplegia
- Being tested
- gait training
- Keywords
- gait, diplegia, ankle weight, botox injection
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gait trainingOther
Also called rehabilitation
walking forward, sideway and backward walking on balance board
| Study group | Role | What they receive |
|---|---|---|
| classical gait training | Active comparator | physical therapy exercises including classical gait training Receives: Other: gait training |
| classical gait training using ankle weight | Active comparator | physical therapy exercises including classical gait training while using ankle weight Receives: Other: gait training |
| gait training using ankle weight after botulinum toxin injection | Experimental | physical therapy exercises including classical gait training while using ankle weight and with BOTOX injection Receives: Other: gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of knee excursion during gait
evaluation of knee flexion range of motion during gait using two dimension gait analysis.
Measured: after 3 months of the treatment program.
evaluation of spasticity: modified ashowrth scale scores
hamstring and calf muscles evaluation of spasticity through passive movement .the score ranged from 0 ( nearly normal) to 5 (rigid in flexion or extension)
Measured: after 3 months of the treatment program.
Secondary outcomes (1)
electromyography to asses spasticity in hamstring and calf muscles
Hoffman/Myogenic reflex to assess spasticity ratio
Measured: after 3 months of the treatment program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start15 Jul 2021
- Primary completion14 Nov 2021
- Study completion25 Nov 2021
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
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahla Mohamed Ibrahim, Cairo University
- Investigators
- Nahla mohamed, phd, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294874
- Sponsor's protocol ID
- pediatrics
- Status last verified
- Mar 2022
- First submitted
- 6 Mar 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: tables and figures of statistical analysis published
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Rehabilitation in Ambulant Diplegic Children Using BOTOX and Ankle Weights
- ClinicalTrials.gov ID
- NCT05294874
- Acronym / sponsor ID
- pediatrics
- Conditions
- Cerebral Palsy, Spastic Diplegia
- Keywords
- gait, diplegia, ankle weight, botox injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 14 Nov 2021 (actual)
- Study completion
- 25 Nov 2021 (actual)
- First posted
- 24 Mar 2022 (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.
Background: Standing and walking serve an individual's basic need to move from place to place, and both are the most common activities that people do on a daily basis.
Aim: to investigate the combined effect of botulinum toxin A (BoNT-A) injection and ankle weight on the gait of diplegic children who are using Ankle foot orthoses.
Detailed description
Methods: Sixty children with spastic diplegia were included in this prospective, controlled trial. Children were divided into three groups, each with 20 patients: Group 1 received classical gait rehabilitation; Group 2 received the same gait training while adding ankle weight ; and Group 3 received the same as group 2 plus botulinum toxin injection. The Modified Ashworth Scale (MAS),knee range-of-motion measures, and Hoffman /Myogenic reflex ratio were used to examine patients before the commencement of treatment and post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| classical gait training | Active comparator | Other: gait trainingphysical therapy exercises including classical gait training |
| classical gait training using ankle weight | Active comparator | Other: gait trainingphysical therapy exercises including classical gait training while using ankle weight |
| gait training using ankle weight after botulinum toxin injection | Experimental | Other: gait trainingphysical therapy exercises including classical gait training while using ankle weight and with BOTOX injection |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- diagnosed as spastic diplegia.
- They were able to follow simple verbal instructions.
- The use of Ankle Foot Orthoses.
- Spasticity grade of 1+ or 2 in both calf and hamstring muscles according to modified Ashworth's scale (MAS).
- level I or II on the Gross Motor Function Classification System (GMFCS).
Key exclusion criteria (3 listed)
- fixed contractures or deformities in the lower limbs.
- surgical orthopedic intervention.
- Botulinum A injection or use of neuromuscular blockers in the previous 6 months before the start of study.
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 |
|---|---|---|
| gait trainingAlso: rehabilitationwalking forward, sideway and backward walking on balance board | Other | classical gait training, classical gait training using ankle weight, gait training using ankle weight after botulinum toxin injection |
Primary outcome
measurement of knee excursion during gait
Time frame: after 3 months of the treatment program.
evaluation of knee flexion range of motion during gait using two dimension gait analysis.
evaluation of spasticity: modified ashowrth scale scores
Time frame: after 3 months of the treatment program.
hamstring and calf muscles evaluation of spasticity through passive movement .the score ranged from 0 ( nearly normal) to 5 (rigid in flexion or extension)
1 secondary outcome
electromyography to asses spasticity in hamstring and calf muscles
Time frame: after 3 months of the treatment program.
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 24 Mar 2022.
- Individual participant dataSharing planned: Yes. tables and figures of statistical analysis published
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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.
Nahla mohamed, phd principal investigator
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 gait training in people with Cerebral Palsy and Spastic Diplegia, 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 3 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 24 Mar 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?
measurement of knee excursion during gait (time frame: after 3 months of the treatment program.). 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 24 Mar 2022.