Diplegic Cerebral PalsyNCT05420363
Influence of Surface Characteristics of Gait Training on Gait Kinematics and Walking Capacity in Children With Diplegic CP
A study testing different walking surfaces and traditional gait training over hard surface only in people with Diplegic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
Using challenging surfaces of gait training, which require constant adjustments of the body's movement patterns to maintain stability and provide different sensory and proprioceptive inputs to mimic real life situation is appropriate for children with CP. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Diplegic Cerebral Palsy
- What is being tested?
- different walking surfaces and traditional gait training over hard surface only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to 1 Sep 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 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Their ages will range from 6 to 8 years old.
- The degree of spasticity will range from grade 1 or 1+ according to Modified Ashworth Scale.
- They will be at level II on GMFCS .
- They will be able to follow verbal command or instructions.
Who cannot join
- 1. Fixed deformities of lower limbs. 2. Sever visual or auditory problems. 3. History of surgical interference in lower limbs less than one year. 4. Botulinum toxin injections to the lower limb during the previous 4 months.
Trial locations and contacts
1 site in 1 country.
walaa A. Abd El-Nabie, Ass. Prof. contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo university , Faculty of Physical Therapy
Cairo
About this study
Official title: Influence of Surface Characteristics of Gait Training on Gait Kinematics and Walking Capacity in Children With Diplegic Cerebral Palsy
Using challenging surfaces of gait training, which require constant adjustments of the body's movement patterns to maintain stability and provide different sensory and proprioceptive inputs to mimic real life situation is appropriate for children with CP. So, the purpose of the current study is to investigate the influence of surface characteristics of gait training on gait kinematics and walking capacity in children with diplegic CP.
Read the detailed description
The purpose of the study is to determine the influence of surface characteristics (different surfaces materials and textures) of gait training on kinematics gait parameters (step length, step width, double support time and cadence) and the functional walking capacity in children with diplegic CP.
- Conditions
- Diplegic Cerebral Palsy
- Being tested
- different walking surfaces, traditional gait training over hard surface only
- Keywords
- CP , Diplegia
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different walking surfacesOther
different surfaces materials and textures as sand ,grass, air mattress , foam mattress ,gravels and Rollator
traditional gait training over hard surface onlyOther
The children will receive gait training over hard surface and even ground only and bare feet without wearing any foot ware or orthosis
| Study group | Role | What they receive |
|---|---|---|
| traditional physical therapy + gait training on different surfaces. | Experimental | Children in study group will receive designed physical therapy program in addition to gait training on different surfaces. Receives: Other: different walking surfaces |
| traditional physical therapy + traditional gait training | Experimental | -Children in control group will receive designed physical therapy program in addition to traditional gait training hard surface . Receives: Other: traditional gait training over hard surface only |
What is being measured
The primary outcome is the main question the study is designed to answer.
kinematics gait parameters
step length
Measured: over 3 months
kinematics gait parameters
step width
Measured: over 3 months
kinematics gait parameters
double support time
Measured: over 3 months
kinematics gait parameters
cadence
Measured: over 3 months
Secondary outcomes (1)
Six-minute walking test
The 6-minute walk test (6MWT) is self-paced walking test commonly used to assess functional capacity in children with CP. It can be easily applied in clinical sitting; it reflects functional capacity in terms of activities of daily living
Measured: over 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diplegic 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Aly Mohamed saied, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420363
- Sponsor's protocol ID
- P.T.REC/012/003599
- Status last verified
- Jun 2022
- First submitted
- 10 Jun 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- 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 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Surface Characteristics of Gait Training on Gait Kinematics and Walking Capacity in Children With Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05420363
- Acronym / sponsor ID
- P.T.REC/012/003599
- Conditions
- Diplegic Cerebral Palsy
- Keywords
- CP , Diplegia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 15 Jun 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.
Using challenging surfaces of gait training, which require constant adjustments of the body's movement patterns to maintain stability and provide different sensory and proprioceptive inputs to mimic real life situation is appropriate for children with CP. So, the purpose of the current study is to investigate the influence of surface characteristics of gait training on gait kinematics and walking capacity in children with diplegic CP.
Detailed description
The purpose of the study is to determine the influence of surface characteristics (different surfaces materials and textures) of gait training on kinematics gait parameters (step length, step width, double support time and cadence) and the functional walking capacity in children with diplegic CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional physical therapy + gait training on different surfaces. | Experimental | Other: different walking surfacesChildren in study group will receive designed physical therapy program in addition to gait training on different surfaces. |
| traditional physical therapy + traditional gait training | Experimental | Other: traditional gait training over hard surface only-Children in control group will receive designed physical therapy program in addition to traditional gait training hard surface . |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Their ages will range from 6 to 8 years old.
- The degree of spasticity will range from grade 1 or 1+ according to Modified Ashworth Scale.
- They will be at level II on GMFCS .
- They will be able to follow verbal command or instructions.
Key exclusion criteria (1 listed)
- 1. Fixed deformities of lower limbs. 2. Sever visual or auditory problems. 3. History of surgical interference in lower limbs less than one year. 4. Botulinum toxin injections to the lower limb during the previous 4 months.
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 |
|---|---|---|
| different walking surfacesdifferent surfaces materials and textures as sand ,grass, air mattress , foam mattress ,gravels and Rollator | Other | traditional physical therapy + gait training on different surfaces. |
| traditional gait training over hard surface onlyThe children will receive gait training over hard surface and even ground only and bare feet without wearing any foot ware or orthosis | Other | traditional physical therapy + traditional gait training |
Primary outcome
kinematics gait parameters
Time frame: over 3 months
step length
kinematics gait parameters
Time frame: over 3 months
step width
kinematics gait parameters
Time frame: over 3 months
double support time
kinematics gait parameters
Time frame: over 3 months
cadence
1 secondary outcome
Six-minute walking test
Time frame: over 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Individual participant dataSharing planned: No
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Dual-Task Training in Children With Spastic Diplegic Cerebral Palsy
Spastic Diplegia Cerebral Palsy
Not yet recruitingObservational study
Sleep Quality, Caregiver Burden, Stress, and Self-Efficacy in Parents of Children With Spastic Diplegic Cerebral Palsy: A Comparison by Night Orthosis Use
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Effects of Transcranial Direct Current Stimulation Combined With Virtual Reality on Gait and Self-Esteem in Children With Spastic Cerebral Palsy
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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.
walaa A. Abd El-Nabie, Ass. Prof. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing different walking surfaces and traditional gait training over hard surface only in people with Diplegic 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 1 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 15 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shimaa A. Mohamed, B.Sc. (01287270680, shimaaaly@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
kinematics gait parameters (time frame: over 3 months). The study lists 4 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 15 Jun 2022.