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

Spastic Hemiplegic Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04171232
• Other study ID #: 1402-ZIHS-013
• Status: Completed
• Phase: N/A
• Start date: November 21, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: July 2020
• Source: Zohra Institute of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

Children with diagnosed spastic hemiplegic cerebral palsy, aged between 6 to 12 years, having sufficient cognitive capacity to understand the basic instructions and to cooperate with the instructor during the assessment and intervention, ambulant- classified as level 1 or 2 on Gross Motor Functional Classification System, able to move the affected body parts easily, and sufficient for functional activity- score of 1 or 2 on Modified Ashworth Scale, good general health, without any other known neurological or orthopedic diagnoses, as confirmed by health professionals and their parents.

Exclusion criteria:

Children who have received motor therapy treatment (e.g. Botulinum Toxin/Constraint-Induced Movement Therapy) in the past six months or plan to receive such treatment during the study,those with severe attention deficits, or those who have a history of seizures which can be triggered by television light (confirmed by the child's therapist or pediatric neurologist), or those children who have visual and/or hearing impairments, or children with musculoskeletal contractures or deformities will be excluded from the study.

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Paralysis
• Spastic Hemiplegic Cerebral Palsy

Intervention

Other:
• Balance It
Each patient in group 1 i.e. Balance It group would be given a 15 minutes long session. Each session would start in standing position and the patient would play the game while they would be instructed to balance the objects falling from above on the imaginary bar (and an actual bar at later stages) held with their both hands, and not let those objects fall by opening their arms wide open and by staying or moving according to the target spot for the set time. This session would be repeated three times a week for two months (total 12 sessions/month).
• Bubble Pop
Each patient in group II i.e. Bubble Pop group would be given a 15 minutes long session. Each session would start in standing position and the patient would play the game while they would be instructed to reach for the balloons coming from random directions and pop them by moving their upper limbs and even their whole body if required. They would also be instructed to avoid a specific object that would result in deduction of their overall game score. This session would be repeated three times a week for two months (total 12 sessions/month).
• Scoop'd
Each patient in group III i.e. Scoop'd group would be given a 15 minutes long session. Each session would start in standing position and the patient would play the game while they would be instructed to hold an imaginary ice cream cone (and an actual basket designed similar to an ice cream cone in later stages) with their both hands and move to catch the ice cream scoops falling at random spots from above, one spot at a time. They would also be instructed to avoid a specific object that would result in deduction of their overall game score. This session would be repeated three times a week for two months (total 12 sessions/month).

Locations

Country	Name	City	State
Pakistan	National Institute of Rehabilitation Medicine	Islamabad	Punjab, Pakistan

Sponsors (1)

Lead Sponsor	Collaborator
Zohra Institute of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Manual Muscle Testing	Muscle power would be measured through Manual Muscle Testing with categories as: Grade 0= No evidence of contractility (complete paralysis) Grade 1= Slight contractility without any movement Grade 2= The patient completes full or partial range of motion with gravity eliminated Grade 3= Completes the available test range of motion against gravity, but tolerates no resistance Grade 4= Movement against gravity plus some resistance Grade 5= Movement against gravity plus full resistance	Upto 8 weeks
Primary	Goniometer	Range of motion would be measured through Goniometer	Upto 8 weeks
Primary	Pediatric Balance Scale	Body balance would be assessed through Pediatric Balance Scale	Upto 8 weeks
Primary	Disability of Arms, Shoulders and Hand Questionnaire (DASH)	Disability of Arms, Shoulders and Hand Questionnaire (DASH) would be used to assess the upper limbs' function	Upto 8 weeks