NCT04246658

Brief Summary

Locomotor activity is accompanied by a number of sensory stimuli: visual, auditory, olfactory, vestibular, and somatosensory. When improving motor skills, incorporating postural reflexes, creating synchronized eye movements, and visual attention skills, the vestibular system is particularly important.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

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

September 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2020

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

5 months

First QC Date

January 15, 2020

Last Update Submit

January 22, 2021

Conditions

Vestibular Rehabilitation

Outcome Measures

Primary Outcomes (2)

  • Growth Motor Function Measure Scale (GMFM).

    Growth Motor Function Measure Scaleis the scale tat will assess the functional gross preinterventiona and after 3 months of the treatment program

    pre intervension and after three months of the intervention to asses the improvent in standing and walking .the highest score indicate improvementg

  • 2D, video based gait assessment system:

    Tracker Video Analysis and Modeling Tool

    2D, video based gait assessment system asses the change in the stance in swing phase before and after three months of the intervention program .

Study Arms (2)

Treatment group

EXPERIMENTAL

gait training on platform swing walkway for 30 minute.

Other: conventional physical therapy programOther: gait training on platform swing walkway

control group

EXPERIMENTAL

conventional physical therapy program

Other: conventional physical therapy program

Interventions

conventional physical therapy programOTHER

traditional physical therapy program

Treatment groupcontrol group
gait training on platform swing walkwayOTHER

gait training on platform swing walkway for 30 minute.

Treatment group

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • were cognitively competent
  • able to understand and follow instructions.

You may not qualify if:

  • if they had fixed contractures
  • deformities of the spine, upper or lower extremities,
  • visual or respiratory disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Badr Univesity in Cairo (BUC)

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer in the deparment of pediatrics and peditaric surgery , faculty of phyical therapy

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 29, 2020

Study Start

September 1, 2019

Primary Completion

January 27, 2020

Study Completion

January 31, 2020

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations

EG(1)