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

Zohra Institute of Health Sciences

Status: Completed

Conditions: Spastic Hemiplegic Cerebral Palsy

Treatments: Other: Bubble Pop; Other: Balance It; Other: Scoop'd

Study type: Interventional

Funder types: Other

Identifiers

NCT04171232

1402-ZIHS-013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Balance It (Group 1)

Active Comparator group

Description:

Children with spastic hemiplegic cerebral palsy were assessed by Manual Muscle Testing (MMT) to determine the muscle power/strength, Goniometer to determine the Range of Motion (ROM), Disability of Arms, Shoulders, and Hand (DASH) questionnaire to assess the function of upper extremity, and Pediatric Balance Scale to determine the body balance and were assigned in the Balance It group. Each subject in first group would complete 8 weeks of augmented reality(AR) therapy sessions which would be aimed to improve the muscle power/strength, range of motion, balance and function. Each subject would be evaluated before their first AR therapy session (pre- interventionally) and after their last AR therapy session (post-interventionally) for changes in muscle power, ROM, upper extremity function and balance.

Treatment:

Other: Balance It

Bubble Pop (Group 2)

Active Comparator group

Description:

Children with hemiplegic cerebral palsy were assessed by Manual Muscle Testing (MMT) to determine the muscle power/strength, Goniometer to determine the Range of Motion (ROM), Disability of Arms, Shoulders, and Hand (DASH) questionnaire to assess the function of upper extremity, and Pediatric Balance Scale to determine the body balance and were assigned in the Bubble Pop group. Each subject in second group would complete 8 weeks of augmented reality(AR) therapy sessions which would be aimed to improve the muscle power/strength, range of motion, balance and function. . Each subject would be evaluated before their first AR therapy session (pre- interventionally) and after their last AR therapy session (post-interventionally) for changes in muscle power, ROM, upper extremity function and balance.

Treatment:

Other: Bubble Pop

Scoop'd (Group 3)

Active Comparator group

Description:

Children with hemiplegic cerebral palsy were assessed by Manual Muscle Testing (MMT) to determine the muscle power/strength, Goniometer to determine the Range of Motion (ROM), Disability of Arms, Shoulders, and Hand (DASH) questionnaire to assess the function of upper extremity, and Pediatric Balance Scale to determine the body balance and were assigned in the Scoop'd group. Each subject in third group would complete 8 weeks of augmented reality(AR) therapy sessions which would be aimed to improve the muscle power/strength, range of motion, balance and function. . Each subject would be evaluated before their first AR therapy session (pre- interventionally) and after their last AR therapy session (post-interventionally) for changes in muscle power, ROM, upper extremity function and balance

Treatment:

Other: Scoop'd