Spastic Hemiplegic Cerebral PalsyNCT04171232
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
A study testing Balance It, Bubble Pop and Scoop'd in people with Spastic Hemiplegic Cerebral Palsy, run by Zohra Institute of Health Sciences at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Spastic Hemiplegic Cerebral Palsy
- What is being tested?
- Balance It, Bubble Pop and Scoop'd
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Nov 2019to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Pakistan1 site
National Institute of Rehabilitation Medicine
Islamabad, Punjab, Pakistan, 44080
About this study
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.
Read the 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.
- Conditions
- Spastic Hemiplegic Cerebral Palsy
- Being tested
- Balance It, Bubble Pop, Scoop'd
- Keywords
- Spastic, Hemiplegia, Cerebral palsy, Child, Upper Extremity, Range of Motion, Muscle Strength, Function, Balance, Augmented Reality, Intervention
- Medical subject headings
- Muscle Spasticity, Hemiplegia, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance ItOther
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 PopOther
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'dOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Balance It (Group 1) | Active comparator | 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. Receives: Other: Balance It |
| Bubble Pop (Group 2) | Active comparator | 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. Receives: Other: Bubble Pop |
| Scoop'd (Group 3) | Active comparator | 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 Receives: Other: Scoop'd |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Upto 8 weeks
Goniometer
Range of motion would be measured through Goniometer
Measured: Upto 8 weeks
Pediatric Balance Scale
Body balance would be assessed through Pediatric Balance Scale
Measured: Upto 8 weeks
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
Measured: Upto 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start21 Nov 2019
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spastic Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zohra Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171232
- Sponsor's protocol ID
- 1402-ZIHS-013
- Status last verified
- Jul 2020
- First submitted
- 18 Nov 2019
- Last updated
- 28 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 35285674
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04171232
- Acronym / sponsor ID
- 1402-ZIHS-013
- Conditions
- Spastic Hemiplegic Cerebral Palsy
- Keywords
- Spastic, Hemiplegia, Cerebral palsy, Child, Upper Extremity, Range of Motion, Muscle Strength, Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zohra Institute of Health SciencesUniversity, hospital or other
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Balance It (Group 1) | Active comparator | Other: Balance ItChildren 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. |
| Bubble Pop (Group 2) | Active comparator | Other: Bubble PopChildren 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. |
| Scoop'd (Group 3) | Active comparator | Other: Scoop'dChildren 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 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance ItEach 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). | Other | Balance It (Group 1) |
| Bubble PopEach 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). | Other | Bubble Pop (Group 2) |
| Scoop'dEach 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). | Other | Scoop'd (Group 3) |
Primary outcome
Manual Muscle Testing
Time frame: Upto 8 weeks
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
Time frame: Upto 8 weeks
Range of motion would be measured through Goniometer
Pediatric Balance Scale
Time frame: Upto 8 weeks
Body balance would be assessed through Pediatric Balance Scale
Disability of Arms, Shoulders and Hand Questionnaire (DASH)
Time frame: Upto 8 weeks
Disability of Arms, Shoulders and Hand Questionnaire (DASH) would be used to assess the upper limbs' function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Derived from this study: PubMed 35285674Malick 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.
- Individual participant dataSharing planned: Yes
Related trials for Spastic Hemiplegic Cerebral Palsy
Not yet recruiting
Effect of Robotic Gloves Training on Upper Limb Coordination, Selective Motor Control and Activities of Daily Living in Children With Hemiparetic Cerebral Palsy
Hemiplegic Cerebral Palsy
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
Active, not recruiting
Virtual Reality Vs Postural Control Training in Children With Cerebral Palsy
Children With Hemiplegic cp
Recruiting
Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
Not yet recruiting
Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy.
Cerebral Palsy Spastic Hemiplegic, Functionnal Neurological Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance It, Bubble Pop and Scoop'd in people with Spastic Hemiplegic Cerebral Palsy, run by Zohra Institute of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manual Muscle Testing (time frame: Upto 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04171232, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.