To investigate the effects of virtual rehabilitation on upper extremity motor learning in patients with hemiplegic cerebral palsy
Design
A single blinded randomized controlled trial and Purposive sampling
technique is used. The sample size was twenty five enrolled between May 2022 to July 2022
Settings and conduct
Patients were taken from Allied hospital Faisalabad and Madina teaching hospital Faisalabad. Group A patients received regular physiotherapy and virtual rehabilitation while Group B patients received physiotherapy sessions. Only the researcher knew which group received regular therapy and other received virtual therapy
Participants/Inclusion and exclusion criteria
• Patients between 5 to 10 years old
• Diagnosed as hemiplegic cerebral palsy
Both genders will include
• Patients with visual impairments and auditory problem
• Patients with severe spasticity (Modified Ashworth spasticity score of 4) were excluded from the study
• patients with Psychological illness
• patients Suffered from uncontrolled seizures
Intervention groups
Patients in the intervention group will be given through regular physiotherapy as well as virtual rehabilitation. The UE VR training sessions will be 2 times each week for 8 weeks (2 months). For training, non-Immersion Microsoft Xbox Kinect will be used. In Intervention sessions each child will participate in a total of 16 sessions of 40 min each.
In control group patients will underwent routine physiotherapy program. The protocol includes passive stretching and strengthening exercises. Each exercise will takes place for 20 minutes 10 repetitions, twice a week, for 8 weeks.
Main outcome variables
To improve the motor functions of upper extremity
To improve range of motion to increase muscle strength and decrease limited activity
To improve reaching ability and grasping function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220616055192N1
Registration date:2022-09-11, 1401/06/20
Registration timing:retrospective
Last update:2022-09-11, 1401/06/20
Update count:0
Registration date
2022-09-11, 1401/06/20
Registrant information
Name
Fizza Hussain
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 8750971
Email address
mspp-fa20-007@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-01, 1401/02/11
Expected recruitment end date
2022-07-30, 1401/05/08
Actual recruitment start date
2022-05-01, 1401/02/11
Actual recruitment end date
2022-07-30, 1401/05/08
Trial completion date
2022-08-01, 1401/05/10
Scientific title
effects of virtual rehabilitation on upper extremity motor learning in hemiplegic cerebral palsy
Public title
effects of virtual rehabilitation on upper extremity motor learning in hemiplegic cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 5 to 10 years old
Diagnosed as hemiplegic cerebral palsy
Both genders will include
Being able to cooperate and being motivated will include in the study
Patients who are able to understand and clearly follow verbal instructions and command that include in training and evaluation.
Patients with Gross Motor Function Classification Scale level 1, 2 and 3 will include
Exclusion criteria:
Patients with visual impairments and auditory problem
Patients with severe spasticity (Modified Ashworth spasticity score of 4) excluded from the study
Patients with Psychological illness
Participants Suffered from uncontrolled seizures
Patients injected with Botulinum toxin injections within past three months were excluded
Patients having prior surgery for spasticity within past 3 months were excluded from study
Age
From 5 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
25
Actual sample size reached:
25
Randomization (investigator's opinion)
Randomized
Randomization description
The method used for randomization was simple randomization. The randomization unit was done on an individual basis. A computer software randomized tool is used.
Blinding (investigator's opinion)
Single blinded
Blinding description
the participants will be unaware in which group they will be allocated after meeting the inclusion criteria an informed consent will be taken from them by physiotherapist.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of The University of Faisalabad
Street address
4-km, Sargodha road, University Town, Faisalabad, Pakistan
City
Faisalabad
Postal code
38000
Approval date
2022-04-07, 1401/01/18
Ethics committee reference number
TUF/DR/MSPP/332
Health conditions studied
1
Description of health condition studied
Cerebral palsy is a prevalent neurodevelopmental disorder that ranging from 1.5 to 2.5/1000 births beginning in the early childhood and continues throughout life. It causing the non-progressive disturbance of motor function that influences posture and movement, motor coordination with secondary complications of contractures and bone deformity. These alternations leading to hindrance in independent performance of daily activities
ICD-10 code
G80.9
ICD-10 code description
Cerebral palsy, unspecified
Primary outcomes
1
Description
spasticity and impaired range of motion in the upper extremity
Timepoint
motor function will be measured at start of treatment sessions and after eight weeks after treatment sessions finished
Method of measurement
modified ashworth scale will use
2
Description
motor dysfunction in the upper limb
Timepoint
motor function will be measured at start of treatment sessions and after eight weeks after treatment sessions finished
Method of measurement
ABILHAND - KIDS and PMAL scale will use
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group Patients in this group will be given through regular physiotherapy as well as virtual rehabilitation. The Upper extremity Virtual Rehabilitation training sessions will be two times each week for eight weeks (2 months). For training, non-Immersion Microsoft Xbox Kinect will be used. The Xbox-Kinect display place used an infrared camera to detect handlers' physical motions in 3-D space for interactive activities inside the game, eliminating the requirement for the user to carry an interface device. In Intervention sessions each child will participate in a total of sixteen sessions of forty minute each.
Category
Rehabilitation
2
Description
Control group: In this group patients will underwent routine physiotherapy program. The protocol includes passive stretching and strengthening exercises. On the affected side, the therapist will use resistance to strengthen the muscles. Each exercise will takes place for 20 minutes 10 repetitions, twice a week, for 8 weeks
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Madina Teaching Hospital
Full name of responsible person
Brig. Dr. Munir Ahmad
Street address
Sargodha Road, University Town, Faisalabad, Pakistan Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 8869861
Email
info@mth.org.pk
2
Recruitment center
Name of recruitment center
Allied Hospital Faisalabad
Full name of responsible person
Rashid Maqbool
Street address
Jail Road Adjacent Faisalabad Medical University, near Sargodha road Faisalabad, Pakistan
City
Faisalabad
Postal code
38000
Phone
+92 41 9210082
Email
info@pmc.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The university of Faisalabad
Full name of responsible person
Dr. M. KHALEEQ-UR-RAHMAN
Street address
4 km, Sargodha Road, University Town, Faisalabad, Pakistan
City
Faisalabad
Postal code
38000
Phone
+92 41 87509715
Email
rector@tuf.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Dr. Sidra Majeed
Position
Associate Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
4 km, Sargodha Road, University Town, Faisalabad, Pakistan
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 334 7731241
Email
sidra.majeed@tuf.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Fizza Hussain
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
83/A Millat colony No. 2 D type Colony Faisalabad, Pakistan
City
Faisalabad
Province
Punjab
Postal code
38080
Phone
+92 304 1676206
Email
drfizzahussain206@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Fizza Hussain
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
83 /A Millat Colony No.2 D type colony Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38080
Phone
+92 304 1676206
Email
drfizzahussain206@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
All collected deidentified participant data set for the outcome measures
When the data will become available and for how long
4 months after publication
To whom data/document is available
people working in the academic institutions
Under which criteria data/document could be used
IPD and any additional supporting documents will be provided for research on similar topic and can be obtained by asking through contact person