Gait, SpasticNCT05579535
Effect of Weight on Hip Excursion During Gait
A study testing gait training exercises in people with Gait, Spastic, run by Cairo University at 1 site in Egypt.
Trial summary
Background: Children with diplegia had considerably larger hip and knee excursion during gait cycle than did normal developing children. Objective: To investigate the effect of using weight around the ankle on hip excursion in children with diplegia. Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Gait, Spastic
- What is being tested?
- gait training exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Aug 2022to 7 Oct 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 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- able to follow simple basic commands,
- identified with gait abnormalities described as level II on Gross Motor Function Classification System (GMFCS).
- diagnosed as spastic diplegia.
Who cannot join
- severe visual or auditory problems,
- lower limb surgical orthopaedic surgery or
- BOTOX injection in the six months preceding the start of the study,
- and uncontrolled seizures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Weight on Hip Excursion During Gait in Children With Diplegia
Background: Children with diplegia had considerably larger hip and knee excursion during gait cycle than did normal developing children.
Objective: To investigate the effect of using weight around the ankle on hip excursion in children with diplegia.
Read the detailed description
Fifty children with spastic diplegic cerebral palsy were assigned into two groups at random (A, B). Both groups had received the same prescribed exercise program with classical gait training for group A and gait training while using weight around ankle for group B. Treatment was conducted for one hour three sessions per week for successive 3 months. Two-dimensional (2D) gait analysis was used to evaluate hip excursion throughout the gait cycle before and after three months of therapy.
- Conditions
- Gait, Spastic
- Being tested
- gait training exercises
- Keywords
- Ankle;, diplegia, gait, hip excursion, weight
- Medical subject headings
- Gait Disorders, Neurologic, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gait training exercisesOther
Also called gait rehabilitation
walking exercises in different directions
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | classical gait training Receives: Other: gait training exercises |
| group B | Experimental | gait training while using weight around ankle Receives: Other: gait training exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
hip excursion
hip excursion during gait cycle
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start3 Aug 2022
- Primary completion3 Oct 2022
- Study completion7 Oct 2022
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 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
- NCT05579535
- Sponsor's protocol ID
- weight during gait
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: available when contact the corresponding author including protocol
Publications
Rodda J, Graham HK. Classification of gait patterns in spastic hemiplegia and spastic diplegia: a basis for a management algorithm. Eur J Neurol. 2001 Nov;8 Suppl 5:98-108. doi: 10.1046/j.1468-1331.2001.00042.x.
PubMed 11851738
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Weight on Hip Excursion During Gait in Children With Diplegia
- ClinicalTrials.gov ID
- NCT05579535
- Acronym / sponsor ID
- weight during gait
- Conditions
- Gait, Spastic
- Keywords
- Ankle;, diplegia, gait, hip excursion, weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 13 Oct 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: Children with diplegia had considerably larger hip and knee excursion during gait cycle than did normal developing children.
Objective: To investigate the effect of using weight around the ankle on hip excursion in children with diplegia.
Detailed description
Fifty children with spastic diplegic cerebral palsy were assigned into two groups at random (A, B). Both groups had received the same prescribed exercise program with classical gait training for group A and gait training while using weight around ankle for group B. Treatment was conducted for one hour three sessions per week for successive 3 months. Two-dimensional (2D) gait analysis was used to evaluate hip excursion throughout the gait cycle before and after three months of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Other: gait training exercisesclassical gait training |
| group B | Experimental | Other: gait training exercisesgait training while using weight around ankle |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- able to follow simple basic commands,
- identified with gait abnormalities described as level II on Gross Motor Function Classification System (GMFCS).
- diagnosed as spastic diplegia.
Key exclusion criteria (4 listed)
- severe visual or auditory problems,
- lower limb surgical orthopaedic surgery or
- BOTOX injection in the six months preceding the start of the study,
- and uncontrolled seizures.
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 training exercisesAlso: gait rehabilitationwalking exercises in different directions | Other | group A, group B |
Primary outcome
hip excursion
Time frame: 3 months
hip excursion during gait cycle
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 Oct 2022.
- Background: PubMed 11851738Rodda J, Graham HK. Classification of gait patterns in spastic hemiplegia and spastic diplegia: a basis for a management algorithm. Eur J Neurol. 2001 Nov;8 Suppl 5:98-108. doi: 10.1046/j.1468-1331.2001.00042.x.
- Individual participant dataSharing planned: Yes. available when contact the corresponding author including protocol
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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 exercises 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 3 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 Oct 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?
hip excursion (time frame: 3 months). 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 NCT05579535, 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 13 Oct 2022.