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Weight Distribution Asymmetry in Relation to Speed During Gait in Children With Spastic Cerebral Palsy.

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ClinicalTrials.gov Identifier: NCT04636424
Recruitment Status : Completed
First Posted : November 19, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Nahla Mohamed Ibrahim, Cairo University

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Gait, Spastic Other: assesment of gait Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Weight Distribution Asymmetry in Relation to Speed During Gait in Children With Spastic Cerebral Palsy.
Actual Study Start Date : December 3, 2019
Actual Primary Completion Date : March 5, 2020
Actual Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: spastic diplegic group
assessment of the speed and weight distribution during gait
 Other: assesment of gait
speed and weight distribution during gait
Experimental: hemiplegic group
assessment of the speed and weight distribution during gait
 Other: assesment of gait
speed and weight distribution during gait


Outcome Measures
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Primary Outcome Measures :
  1. speed of gait [ Time Frame: 12 weaks ]
    the velocity of walking


Secondary Outcome Measures :
  1. foot to foot distribution [ Time Frame: 12 weaks ]
    weight loaded on each lower limb during gait assessment


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The selection criteria to the diplegic group were as follows:

  1. children diagnosed as spastic diplegia or hemiplegia;
  2. the ability to stand independently without support for not less than 30 seconds;
  3. the ability to walk independently; a classification of level II in the Gross Motor Function Classification System (GMFCS);
  4. and capability to understand simple verbal commands.

Exclusion criteria:

  1. Participants were excluded if they were treated for lower limbs orthopedic surgical or with botulinum toxin injection within the last 6 months
  2. or if they had fixed lower limb deformity.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04636424


Locations
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Egypt
Faculty of Physical Therapy,Cairo University
Cairo, Giza, Egypt, 02
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Nahla Mohamed Cairo University
More Information
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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

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Responsible Party: Nahla Mohamed Ibrahim, Doctoral degree (lecturer), Cairo University
ClinicalTrials.gov Identifier: NCT04636424    
Other Study ID Numbers: correlation study
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: the results will be shared with other researchers as the paper published
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: after publication of the paper
Access Criteria: through the journal of the published paper

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nahla Mohamed Ibrahim, Cairo University:
assymetry-gait-speed-cerebral palsy
Additional relevant MeSH terms:
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Muscle Spasticity
Cerebral Palsy
Gait Disorders, Neurologic
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations