NCT05692336

Brief Summary

the study is carried out to identify If there is any difference between the effectiveness of Vestibular training and Dual task training on balance in children with Diplegic Cerebral Palsy. so in this study the sample will be divided into two equal groups, each group will recieve only one type of training ( vestibular training or dual task training ) the balance of the diplegic children will be assessed before and after using HUMAC balance system and pediatric balance scale , the results will be compared between both groups and if there is one training is more effective than the other , it will be recommended most in the future treatment program.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

1.1 years

First QC Date

December 22, 2022

Last Update Submit

January 18, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Static Balance

    static balance will be assessed using HUMAC balance system , a comparison of the results between two groups will be carried out , and the more effective treatment program will be more recommended than the other

    2 months of training

  • dynamic balance

    dynamic balance will be assessed using pediatric balance scale and a comparison between the results of the two groups will be done to recommend one over the other.

    2 months of training

  • which training will be more beneficial for the diplegic child balance

    after the results of both groups (for static and dynamic balance) are analyzed one treatment will be recommended most (the treatment for the group that has greater balance improvement ).

    2 months

Study Arms (2)

vestibular training

EXPERIMENTAL

balance training that focus on vestibular system stimulation like when the eyes are folded while standing on a balance board or walking on swinging boards

Other: vestibular training

dual task training

EXPERIMENTAL

The children received special balance training in the form of dual-task training performing balance activities as a basic task in conjunction with second task that includes upper limb activity using basketball and long rings shaft or cognitive task like telling a story during balance training .

Other: dual task training

Interventions

balance training in the form of vestibular training

vestibular training

balance training in the form of dual task training

dual task training

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • clinical diagnosis of diplegic cerebral palsy .
  • age range : from 5 to 10 years old.
  • The degree of spasticity is between grade 1 or 1+ according to Modified Ashworth Scale (Charalambous ,2013).
  • They are at level I OR II on Gross Motor Function Classification System .
  • All the children were able to follow verbal command and instructions.

You may not qualify if:

  • Children that suffer from epilepsy.
  • Severe visual and auditory problems.
  • Structural or fixed soft tissue deformities of Lower extremities.
  • Severe mental retardation.
  • Botox injection in the lower extremity in the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy Cairo University

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • amira A mahmoud

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

amira A mahmoud, bachelor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
teaching assisstant at faculty of physical therapy

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 20, 2023

Study Start

February 20, 2022

Primary Completion

March 30, 2023

Study Completion

April 30, 2023

Last Updated

January 20, 2023

Record last verified: 2023-01

Locations