This study investigates the effect of virtual reality on trunk control and gross motor function in children with developmental delays
Design
Randomized controlled, parallel group trial with blinded outcome accessors. it will be lottery method where numbers will be computer generated.
Settings and conduct
The place of the study: The children hospital & institute of Faisalabad; the study population: children with developmental delays; type of the blinding: single blind (outcome assessors kept blind)
Participants/Inclusion and exclusion criteria
Inclusion criteria; Willing to give consent; Age limit 3-8 years; Ablility to follow visual and verbal commands; Gross motor function level II-IV; Those with an appropriate cognitive level to understand a VR exercise program. Exclusion criteria: Inability to follow instructions; Other Neurological disorders (polio, epilepsy, seizures, trumatic brain injury) Malignancies and Infectious disorders (encephalitis, meningitis, malignancy, tumors); Patients having musculoskeletal problems (fracture, congenital hip dysplesia); Spastic CP with Ashworth scale 2+; Any surgery within last 6 months; A diagnosis of Autism or attention deficit disorders; Psychiatric disorder
Intervention groups
Active control group will receives neurodevelopmental treatment (NDT) focusing on trunk control through dynamic co-activation, weight shift facilitation, and trunk rotation induction for half an hour 3 times a week for 6 weeks. Intervention group undergoes 24 sessions combining NDT with immersive VR protocol targeting trunk control and gross motor function over 6 weeks. Sessions include 15 minutes of NDT followed by 15 minutes of VR gameplay with dynamic adaptations for motor learning including rest period of 1 minute.
Main outcome variables
The trunk control measurement scale score; gross motor function scale-88 score, HINE performa section 3
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240307061203N2
Registration date:2024-05-14, 1403/02/25
Registration timing:retrospective
Last update:2024-05-14, 1403/02/25
Update count:0
Registration date
2024-05-14, 1403/02/25
Registrant information
Name
Gulraiz Ayub
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 87509715
Email address
2022-ms-pt-014@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-17, 1402/11/28
Expected recruitment end date
2024-04-17, 1403/01/29
Actual recruitment start date
2024-02-17, 1402/11/28
Actual recruitment end date
2024-04-30, 1403/02/11
Trial completion date
2024-04-30, 1403/02/11
Scientific title
Effect of virtual reality on trunk control and gross motor function in children with developmental delays
Public title
virtual reality on trunk control and gross motor function in children with developmental delays
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willing to participate and giving consent
Both genders male/female
Age limit of 3-8 years of children
Being able to follow visual and verbal commands
Gross motor function level II-IV
Those with an appropriate cognitive level to understand a VR exercise program
Exclusion criteria:
Inability to follow instructions
Other Neurological disorders (polio, epilepsy, seizures, traumatic brain injury)
Malignancies and Infectious disorders ( encephalitis, meningitis, malignancy, tumors )
Patients having musculoskeletal problems ( fracture, congenital hip dyspepsia)
Spastic CP with Ashworth scale 2 +
Any surgery within last 6 months
A diagnosis of Autism or attention deficit disorders
Psychiatric disorder or any cardiac anomalies affecting exercise intolerance
Less than 4 months after undergoing surgery
Age
From 3 years old to 8 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
22
Actual sample size reached:
22
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization process will utilize a lottery method, where numbers generated by a computer will be drawn based on the sample size. The numbers will then be allocated to different groups in the poll, ensuring an effective distribution.
Blinding (investigator's opinion)
Single blinded
Blinding description
In single blinded outcome assessors will kept unaware of which participants received the experimental treatment and which received the control intervention. This blinding helps to prevent conscious or unconscious biases that could influence the assessment of study outcomes.
Research and Ethics/ technical committe for The University of Faisalabad
Street address
Faisal Town, West Canal Road, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Approval date
2024-01-05, 1402/10/15
Ethics committee reference number
TUF/Addl Reg/SB/753
Health conditions studied
1
Description of health condition studied
gross motor developmental delays
ICD-10 code
R62.0
ICD-10 code description
Delayed milestone in childhood
Primary outcomes
1
Description
Trunk control
Timepoint
Before and after 6 weeks of intervention
Method of measurement
Trunk control measurement scale
2
Description
Gross motor function
Timepoint
Before and after 6 weeks of intervention
Method of measurement
Gross motor functional scale-88
Secondary outcomes
1
Description
Tone
Timepoint
Before and after 6 weeks of intervention
Method of measurement
Modified Ashworth Scale
2
Description
Cognition
Timepoint
Before and after 6 weeks of intervention
Method of measurement
HINE performa section 3
Intervention groups
1
Description
Active Control group: this group will receive handling and facilitation principle of neurodevelopmental treatment approach will be utilize to encourage trunk weight bearing, uprightness and elongation. This intervention will be in three stages. In the initial stage, to stimulate flexors and extensors muscles dynamic co-activation and to maintain trunk upright without tilting body in sagital plane children will be asked to play with toys infront of them. In the second stage children will be asked to play with toys. Subsequently, toys will be placed at the child’s side to prompt weight shift, facilitating dynamic co-activation of trunk muscles and elongation of the weight-bearing side. In the third stage, elongation of the weight-bearing side will be continued by placing a toy at approximately 45 degree to induce trunk rotation in horizontal plane. Trunk rotation will be fostering on weight bearing side in this phase.
Category
Rehabilitation
2
Description
Intervention group: Patient in this group will receive handling and facilitation principle of neurodevelopment treatment approach will be utilize to encourage trunk weight bearing, uprightness and elongation. along with immersive virtual reality treatment protocol. It will involves 18 sessions in alternating three days a week for 6 weeks. this session will last for 30 minutes, starting with 15 minute of neurodevelopmental treatment followed by 15 minutes of playing immersive VR games with 1 minute rest interval. The first game involves participants features a bird’s flight (bird’s back), task is to collect to collect golden coins with dynamic adaptation for head and trunk movements. The second game representing planetary exploration (solar system) with head-trunk rotations, and third game entails climbing a elevator ride fouces on sitting posture, elongation and weight transfer, promoting hand and body movement.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Children Hospital & Institute of Child Health Faisalabad
Full name of responsible person
Dr. Gulraiz Ayub; PT
Street address
GC university, Jhang road, New Campus Dr, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 9203065
Email
2022-ms-pt-014@tuf.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Syed Saqlain Babar
Street address
Faisal Town, West Canal Road, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 315 6205017
Email
syedsaqlain264@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The University of Faisalabad
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
The University of Faisalabad
Position
consultant clinical physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisal Town, West Canal Road, Faisalabad, Punjab
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
0092413357916317
Email
zainboota9698@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr. Warda Jabbar
Position
Physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisal Town, West canal Road Faisalabad, Punjab
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 313 8650848
Email
Wardah.jabbar5@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The Univeristy of Faisalabad
Full name of responsible person
Dr. Gulraiz Ayub
Position
physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisal town, west canal road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
0092410075508
Email
gulraizayub70@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available