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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

Primary Purpose

Spastic Hemiplegic Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Balance It
Bubble Pop
Scoop'd
Sponsored by
Zohra Institute of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Hemiplegic Cerebral Palsy focused on measuring Spastic, Hemiplegia, Cerebral palsy, Child, Upper Extremity, Range of Motion, Muscle Strength, Function, Balance, Augmented Reality, Intervention

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • National Institute of Rehabilitation Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Balance It (Group 1)

Bubble Pop (Group 2)

Scoop'd (Group 3)

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

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
Goniometer
Range of motion would be measured through Goniometer
Pediatric Balance Scale
Body balance would be assessed through Pediatric Balance Scale
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

Secondary Outcome Measures

Full Information

First Posted
November 18, 2019
Last Updated
July 25, 2020
Sponsor
Zohra Institute of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04171232
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 21, 2019 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zohra Institute of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Hemiplegic Cerebral Palsy
Keywords
Spastic, Hemiplegia, Cerebral palsy, Child, Upper Extremity, Range of Motion, Muscle Strength, Function, Balance, Augmented Reality, Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Balance It (Group 1)
Arm Type
Active Comparator
Arm 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.
Arm Title
Bubble Pop (Group 2)
Arm Type
Active Comparator
Arm 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.
Arm Title
Scoop'd (Group 3)
Arm Type
Active Comparator
Arm 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
Intervention Type
Other
Intervention Name(s)
Balance It
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Bubble Pop
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Scoop'd
Intervention Description
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).
Primary Outcome Measure Information:
Title
Manual Muscle Testing
Description
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
Time Frame
Upto 8 weeks
Title
Goniometer
Description
Range of motion would be measured through Goniometer
Time Frame
Upto 8 weeks
Title
Pediatric Balance Scale
Description
Body balance would be assessed through Pediatric Balance Scale
Time Frame
Upto 8 weeks
Title
Disability of Arms, Shoulders and Hand Questionnaire (DASH)
Description
Disability of Arms, Shoulders and Hand Questionnaire (DASH) would be used to assess the upper limbs' function
Time Frame
Upto 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National Institute of Rehabilitation Medicine
City
Islamabad
State/Province
Punjab, Pakistan
ZIP/Postal Code
44080
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
35285674
Citation
Malick WH, Butt R, Awan WA, Ashfaq M, Mahmood Q. Effects of Augmented Reality Intervention on the Range of Motion and Muscle Strength of Upper Extremity in Children with Spastic Hemiplegic Cerebral Palsy: A Randomized Clinical Trial. Games Health J. 2022 Jun;11(3):168-176. doi: 10.1089/g4h.2021.0128. Epub 2022 Mar 14.
Results Reference
derived

Learn more about this trial

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

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