Gait, SpasticNCT04636424
Weight Distribution Asymmetry in Relation to Speed During Gait in Children With Spastic Cerebral Palsy.
A study testing assesment of gait in people with Gait, Spastic, run by Cairo University at 1 site in Egypt.
Trial summary
Background: Improving walking ability is one of the major concerns in therapeutic interventions for children with cerebral palsy. Aim: determine the relation between the weight distributed on both lower limb and speed during walking. Read more about this study
- Who is it for?
- Ages 10 to 12 years
- Conditions the study is for
- Gait, Spastic
- What is being tested?
- assesment of gait
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Dec 2019to 1 Nov 2020
- 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 10 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The selection criteria to the diplegic group were as follows:
- children diagnosed as spastic diplegia or hemiplegia;
- the ability to stand independently without support for not less than 30 seconds;
- the ability to walk independently; a classification of level II in the Gross Motor Function Classification System (GMFCS);
- and capability to understand simple verbal commands.
Who cannot join
- Participants were excluded if they were treated for lower limbs orthopedic surgical or with botulinum toxin injection within the last 6 months
- or if they had fixed lower limb deformity.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy,Cairo University
Cairo, Giza Governorate, 02
About this study
Background: Improving walking ability is one of the major concerns in therapeutic interventions for children with cerebral palsy.
Aim: determine the relation between the weight distributed on both lower limb and speed during walking.
Read the detailed description
sixty children with spastic diplegia (group A) and forty-five with hemiparesis ( group B) with age ranged from ten to twelve, they had spasticity grade 1 and 1+ according to modified ashworth scale and they were able to walk with assistance (level II on Gross Motor Classification System).Evaluation was held by the Biodex gait trainer for measuring weight distribution on both lower limbs and speed during gait to determine if there was a relation between weight distribution asymmetry and the speed of gait of those children
- Conditions
- Gait, Spastic
- Being tested
- assesment of gait
- Keywords
- assymetry-gait-speed-cerebral palsy
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assesment of gaitOther
speed and weight distribution during gait
| Study group | Role | What they receive |
|---|---|---|
| spastic diplegic group | Experimental | assessment of the speed and weight distribution during gait Receives: Other: assesment of gait |
| hemiplegic group | Experimental | assessment of the speed and weight distribution during gait Receives: Other: assesment of gait |
What is being measured
The primary outcome is the main question the study is designed to answer.
speed of gait
the velocity of walking
Measured: 12 weaks
Secondary outcomes (1)
foot to foot distribution
weight loaded on each lower limb during gait assessment
Measured: 12 weaks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start3 Dec 2019
- Primary completion5 Mar 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gait, SpasticStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 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, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636424
- Sponsor's protocol ID
- correlation study
- Status last verified
- Nov 2020
- First submitted
- 8 Nov 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the results will be shared with other researchers as the paper published
Publications
Nahla M. Ibrahim, Mai Elsayed Abbass. EFFECT OF PEDAL TRAINING ON GAIT SPEED IN CHILDREN WITH HEMIPARETIC CEREBRAL PALSY.Int J Physiother Res 2017;5(6):2560-65. ISSN 2321-1822
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Distribution Asymmetry in Relation to Speed During Gait in Children With Spastic Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT04636424
- Acronym / sponsor ID
- correlation study
- Conditions
- Gait, Spastic
- Keywords
- assymetry-gait-speed-cerebral palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 19 Nov 2020 (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: Improving walking ability is one of the major concerns in therapeutic interventions for children with cerebral palsy.
Aim: determine the relation between the weight distributed on both lower limb and speed during walking.
Detailed description
sixty children with spastic diplegia (group A) and forty-five with hemiparesis ( group B) with age ranged from ten to twelve, they had spasticity grade 1 and 1+ according to modified ashworth scale and they were able to walk with assistance (level II on Gross Motor Classification System).Evaluation was held by the Biodex gait trainer for measuring weight distribution on both lower limbs and speed during gait to determine if there was a relation between weight distribution asymmetry and the speed of gait of those children
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spastic diplegic group | Experimental | Other: assesment of gaitassessment of the speed and weight distribution during gait |
| hemiplegic group | Experimental | Other: assesment of gaitassessment of the speed and weight distribution during gait |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- children diagnosed as spastic diplegia or hemiplegia;
- the ability to stand independently without support for not less than 30 seconds;
- the ability to walk independently; a classification of level II in the Gross Motor Function Classification System (GMFCS);
- and capability to understand simple verbal commands.
Key exclusion criteria (2 listed)
- Participants were excluded if they were treated for lower limbs orthopedic surgical or with botulinum toxin injection within the last 6 months
- or if they had fixed lower limb deformity.
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 |
|---|---|---|
| assesment of gaitspeed and weight distribution during gait | Other | hemiplegic group, spastic diplegic group |
Primary outcome
speed of gait
Time frame: 12 weaks
the velocity of walking
1 secondary outcome
foot to foot distribution
Time frame: 12 weaks
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 19 Nov 2020.
- BackgroundNahla M. Ibrahim, Mai Elsayed Abbass. EFFECT OF PEDAL TRAINING ON GAIT SPEED IN CHILDREN WITH HEMIPARETIC CEREBRAL PALSY.Int J Physiother Res 2017;5(6):2560-65. ISSN 2321-1822
- Individual participant dataSharing planned: Yes. the results will be shared with other researchers as the paper published
Related trials for Gait, Spastic
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Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
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Flexibility, Resistance, Aerobic, Movement Execution Training in Adults With Hereditary Spastic Paraplegia
Hereditary Spastic Paraplegia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
Not yet recruiting
Dual-Task Training in Children With Spastic Diplegic Cerebral Palsy
Spastic Diplegia Cerebral Palsy
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 study director
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 assesment of gait in people with Gait, Spastic, 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 2 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 19 Nov 2020. 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?
speed of gait (time frame: 12 weaks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04636424, which also lists 1 linked publication.
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 19 Nov 2020.