Effect of Weight on Hip Excursion During Gait | NCT05579535

Studies
Effect of Weight on Hip Excursion During Gait

NCT05579535

Sponsor

Cairo University

Status

Completed

Last Update Posted

Oct 13, 2022Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Gait, Spastic

Interventions

gait training exercises

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 3, 2022Actual

Primary Completion Date

Oct 3, 2022Actual

Completion Date

Oct 7, 2022Actual

First Submitted Date

Oct 10, 2022

First Submission Date that Met QC Criteria

Oct 11, 2022

First Posted Date

Oct 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2022

Last Update Posted Date

Oct 13, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nahla Mohamed Ibrahim, lecturer at pediatric department faculty of physical therapy, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group A	Active Comparator	classical gait training	Other: gait training exercises
group B	Experimental	gait training while using weight around ankle	Other: gait training exercises

Interventions

Name	Type	Description	Arm Group Labels	Other Names
gait training exercises	Other	walking exercises in different directions	group A group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hip excursion	hip excursion during gait cycle	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Nahla mohamed, phd	Cairo University	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11851738	Background	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.

ID	Term
D020233	Gait Disorders, Neurologic
D001835	Body Weight

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms