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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06036069
Other study ID # P.T.REC/012/004335
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 15, 2023
Est. completion date January 20, 2024

Study information

Verified date October 2023
Source South Valley University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Children had Down syndrome often have impaired balance and postural control and result as less active than their peers that can lead to reduced quality of life and movement skills. Effects of physical activity may be important in preventing falling risk and health consequences in those children


Description:

Sixty children from both genders (boys and girls) participated in this study, their ages ranged from 10 to 16 years and they were randomized into three groups of same number (A, B and C). Groups (A) received conventional physical therapy program, group (B) received the same conventional physical therapy program of group (A) and core stability exercises while group (C) received the same conventional physical therapy program of group (A and B) and whole body vibration exercise


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date January 20, 2024
Est. primary completion date January 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 16 Years
Eligibility Inclusion Criteria: - Aged between 10 to 16 years. - Able to recognize commands given to them. - Understand our verbal command and encouragement. - Stand and walk independently without repeated falling. Exclusion Criteria: - Children with any neurological (signs of epilepsy and instability of atlantoaxial joint). - Musculoskeletal, or mobility disorders. - Cardiac anomalies. - Vision or hearing loss.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Conventional physical therapy
Standing with feet together while the therapist was sitting behind and manually locking the child knees. Step standing with the therapist behind the child. High step standing and trying to keep balanced. The child stood on exercise mattress. Single leg stance "unilateral standing" with assistance. The child was standing on exercise mattress. Standing on a declined surface by using wedge. The child was standing on wedge towards the descending direction. Standing with manual locking of the knees. Changing position. Gait training. Static and dynamic muscle contraction.

Locations

Country Name City State
Egypt Ragaee Saeed Mahmoud Giza Faisal

Sponsors (1)

Lead Sponsor Collaborator
Ragaee Saeed Mahmoud

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Biodex Balance System it is a reliable and objective assessment in order to quantify dynamic balance before intervention and after 12 weeks of intervention
Secondary Hand-held dynamometer It is a portable device (Nicholas Manual Muscle Tester, Model 01160; Lafayette Instrument, Lafayette, IN), characterized as low-cost and convenient method before intervention and after 12 weeks of intervention
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