- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04171232
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab, Pakistan
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Islamabad, Punjab, Pakistan, Pakistan, 44080
- National Institute of Rehabilitation Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Balance It (Group 1)
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.
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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).
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Active Comparator: Bubble Pop (Group 2)
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.
|
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).
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Active Comparator: Scoop'd (Group 3)
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
|
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Manual Muscle Testing
Time Frame: Upto 8 weeks
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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
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Goniometer
Time Frame: Upto 8 weeks
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Range of motion would be measured through Goniometer
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Upto 8 weeks
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Pediatric Balance Scale
Time Frame: Upto 8 weeks
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Body balance would be assessed through Pediatric Balance Scale
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Upto 8 weeks
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Disability of Arms, Shoulders and Hand Questionnaire (DASH)
Time Frame: Upto 8 weeks
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Disability of Arms, Shoulders and Hand Questionnaire (DASH) would be used to assess the upper limbs' function
|
Upto 8 weeks
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1402-ZIHS-013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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