NCT04636424

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

November 8, 2020

Last Update Submit

November 13, 2020

Conditions

Keywords

assymetry-gait-speed-cerebral palsy

Outcome Measures

Primary Outcomes (1)

  • speed of gait

    the velocity of walking

    12 weaks

Secondary Outcomes (1)

  • foot to foot distribution

    12 weaks

Study Arms (2)

spastic diplegic group

EXPERIMENTAL

assessment of the speed and weight distribution during gait

Other: assesment of gait

hemiplegic group

EXPERIMENTAL

assessment of the speed and weight distribution during gait

Other: assesment of gait

Interventions

speed and weight distribution during gait

hemiplegic groupspastic diplegic group

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy,Cairo University

Cairo, Giza Governorate, 02, Egypt

Location

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nahla Mohamed

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral degree (lecturer)

Study Record Dates

First Submitted

November 8, 2020

First Posted

November 19, 2020

Study Start

December 3, 2019

Primary Completion

March 5, 2020

Study Completion

November 1, 2020

Last Updated

November 19, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

the results will be shared with other researchers as the paper published

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
after publication of the paper
Access Criteria
through the journal of the published paper

Locations