Viewing Study NCT04171232


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Study NCT ID: NCT04171232
Status: COMPLETED
Last Update Posted: 2020-07-28
First Post: 2019-11-18
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Effect of Augmented Reality Intervention on the Range of Motion, Muscle Strength, Function of Upper Extremity and Balance in Children With Spastic Hemiplegic Cerebral Palsy: A Randomized Clinical Trial
Sponsor: Zohra Institute of Health Sciences
Organization:

Study Overview

Official Title: Effect of Augmented Reality Intervention on the Range of Motion, Muscle Strength, Function of Upper Extremity and Balance in Children With Spastic Hemiplegic Cerebral Palsy: A Randomized Clinical Trial
Status: COMPLETED
Status Verified Date: 2020-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Cerebral Palsy (CP) is a disorder of the development of movement and posture, causing activity limitations attributed to nonprogressive disturbances of the fetal or infant brain that may also affect sensation, perception, cognition, communication, and behavior. Motor control during reaching, grasping, and walking are disturbed by spasticity, dyskinesia, hyperreflexia, excessive coactivation of antagonist muscles, retained developmental reactions, and secondary musculoskeletal malformations, together with paresis and defective programing. Weakness and hypoextensibility of the muscles are due not only to inadequate recruitment of motor units, but also to changes in mechanical stresses and hormonal factors. As it affects the children, therefore it should be emphasized. Effect of Augmented Reality (AR) based therapeutic games on the range of motion, muscle strength,function of upper limb and balance of spastic hemiplegic cerebral palsy children would be assessed through goniometer, manual muscle testing (MMT), disability of Arms, Shoulders, and Hand (DASH) questionnaire, and Pediatric Berg Balance Scale, respectively.
Detailed Description: A total of 30 children with spastic hemiplegic cerebral palsy would be recruited and randomly divided into three groups, 10 in each group. The demo-graphical data would be collected through a general demographic questionnaire. Outcome measures would include Goniometer to determine the Range of Motion (ROM), Manual Muscle Testing (MMT) to determine the upper limb muscle power/strength, disability of Arms, Shoulders, and Hand (DASH) questionnaire to assess the function of upper extremity, and Pediatric Balance Scale to determine the body balance.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: