Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000924651
Ethics application status
Approved
Date submitted
16/05/2023
Date registered
28/08/2023
Date last updated
28/08/2023
Date data sharing statement initially provided
28/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Exer-gaming in Cerebral Palsy
Scientific title
Exer-gaming; the effectiveness of an interactive tool on functional outcomes in Cerebral Palsy'.
Secondary ID [1] 309614 0
None
Universal Trial Number (UTN)
NA
Trial acronym
EGCP
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 329934 0
Condition category
Condition code
Neurological 326840 326840 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exer-gaming will be provided to the subjects through X-box 360 Kinect console. The Kinect sensor will monitor the individual's position and movements as they would move to play certain games. The gaming intervention challenges the overall body posture and movement system, and also stimulates the proprioceptive output as well as provides a certain level of perturbations to the body to improve the balance. The subjects playing the games moves the body and limbs in response to play the virtual games displayed while the sensors assess the direction, impact and target of movements of the subject and feedback is simultaneously being provided to the subject, which keeps the subject motivated and involved in the game.
Kinect games including Kung fu, active 2 and Fifa Soccer 13 will be used as interventions. The games include the head, trunk and limb movements i.e. hitting the ball with head and limbs, kicking, side kicks, turning, punching, bending, squatting etc.
The intervention will be provided in the physiotherapy department under the supervision of physiotherapist. The subjects will play the games themselves suggested by the researcher standing in front of the kinect sensor. The physiotherapist will be monitoring the subject and will make sure the environment is safe and there is no risk of fall or injury. Required rest periods will also be provided during the interventions to avoid fatigue or exertion. A nurse will also be available at the time of interventions for monitoring the overall health of the subjects. The duration of interventions would be 40 minutes per session. A 10-15 minutes warm up and cool down will be done at start and end of intervention respectively including walking (3-5 minutes), quadriceps (5-7 times) and hamstring stretch (5-7 times) . The intervention will be provided 3 times a week for 8 weeks. A total 24 sessions will be provided. the subjects will also be provided with conventional exercise plan. Conventional exercises including positioning, stretching and strengthening.
Intervention code [1] 326109 0
Rehabilitation
Comparator / control treatment
Conventional exercises including positioning, stretching and strengthening. The intervention will be provided in the physiotherapy department under the supervision of physiotherapist. A low to moderate exercises will be provided along with the required rest periods in between the intervention. The duration of interventions would be 40 minutes per session. A 10-15 minutes warm up and cool down will be done at start and end of intervention respectively including walking (3-5 minutes), quadriceps (5-7 times) and hamstring stretch (5-7 times) . The physiotherapist will be monitoring the subject and will make sure the environment is safe and there is no risk of fall or injury. A nurse will also be available at the time of interventions for monitoring the overall health of the subjects. The intervention will be provided 3 times a week for 8 weeks. A total 24 sessions will be provided.
Control group
Active

Outcomes
Primary outcome [1] 334763 0
Trunk Control will be measured using Trunk control measurement scale (TCMS)
Timepoint [1] 334763 0
Baseline
4 weeks post intervention
8 weeks post intervention
12 weeks post intervention (Primary timepoint)
Primary outcome [2] 334764 0
Gross Motor Functions will be measured using Gross motor function measure 88 (GMFM 88)
Timepoint [2] 334764 0
Baseline
4 weeks post intervention
8 weeks post intervention
12 weeks post intervention (Primary timepoint)
Primary outcome [3] 334765 0
Balance will be assessed using Pediatric balance scale (PBS)
Timepoint [3] 334765 0
Baseline
4 weeks post intervention
8 weeks post intervention
12 weeks post intervention (Primary timepoint)
Secondary outcome [1] 421997 0
Upper limb functions will be assessed by using Manual Ability Classification System (MACS)
Timepoint [1] 421997 0
Baseline
4 weeks post intervention
8 weeks post intervention
12 weeks post intervention
Secondary outcome [2] 421998 0
Gait will be assessed by using observational gait analysis (OGS)
Timepoint [2] 421998 0
Baseline
4 weeks post intervention
8 weeks post intervention
12 weeks post intervention
Secondary outcome [3] 421999 0
Quality of life will be assessed by using cerebral palsy quality of life (CPQoL)
Timepoint [3] 421999 0
Baseline
4 weeks post intervention
8 weeks post intervention
12 weeks post intervention
Secondary outcome [4] 422011 0
Social participation will be measured by using participation scale (P-Scale), is valid and reliable and it measures the level of social participation of subjects
Timepoint [4] 422011 0
Baseline
4 weeks post intervention
8 weeks post intervention
12 weeks post intervention
Secondary outcome [5] 423688 0
Pediatric arm function test (PAFT) will be used to assess manual abilities of subjects
Timepoint [5] 423688 0
Baseline
4 weeks post intervention
8 weeks post intervention
12 weeks post intervention

Eligibility
Key inclusion criteria
Subjects with diagnosed with spastic hemiplegic cerebral palsy with age 5 to 17 years with gross motor function level III and IV will be included
Minimum age
5 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The subjects with cognitive, hearing or visual impairments, serious systemic diseases will be excluded

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed using sealed opaque envelops.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The subjects will be allocated to both groups using concealed envelops
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Analysis will be done using SPSS version 23 for all the outcomes and observational gait analysis will be done qualitatively by observing the video recordings of the subjects for particular gait patterns.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2023
Actual
Date of last participant enrolment
Anticipated
7/10/2023
Actual
Date of last data collection
Anticipated
25/01/2024
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment outside Australia
Country [1] 25544 0
Pakistan
State/province [1] 25544 0
Islamabad

Funding & Sponsors
Funding source category [1] 313794 0
Self funded/Unfunded
Name [1] 313794 0
Country [1] 313794 0
Primary sponsor type
Individual
Name
Kiran Khshnood
Address
Riphah International University, Service road, Gulberg expressway, block D, Gulberg greens Islamabad Capital Territory. Islamabad Pakistan
Postal code 44000
Country
Pakistan
Secondary sponsor category [1] 315626 0
None
Name [1] 315626 0
Address [1] 315626 0
Country [1] 315626 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312961 0
Research Ethics Committee Riphah International University Islamabad
Ethics committee address [1] 312961 0
Riphah International University, Service road, Gulberg expressway, block D, Gulberg greens Islamabad Capital Territory. Islamabad Pakistan
Postal code 44000
Ethics committee country [1] 312961 0
Pakistan
Date submitted for ethics approval [1] 312961 0
01/06/2022
Approval date [1] 312961 0
18/07/2022
Ethics approval number [1] 312961 0
F.1.8/2019-SE

Summary
Brief summary
The objective of the study is to determine the effects of exer-gaming on functional outcomes in children with hemiplegic cerebral palsy. The subjects will be recruited as per inclusion criteria and will be randomly allocated into 2 groups i.e. experimental and control. The sample size of is calculated by using G power with confidence interval, margin of error and effect size of 95%, 0.05, and 0.25 respectively. The subjects of both groups will be provided conventional treatment comprising of positioning, stretching and strengthening exercises, whereas experimental group will receive exer-gaming by using x-box Kinect games. The interventions will be give in a safe environment under the supervision of pediatric physiotherapist for 3 days a week for 8 weeks. Assessments would be done at baseline, post 4 and 8 weeks of intervention. Retention effects will also be assessed after post 4 weeks of cessation of intervention in both groups.
Trial website
NA
Trial related presentations / publications
NA
Public notes
NA

Contacts
Principal investigator
Name 126494 0
Ms Kiran Khushnood
Address 126494 0
Riphah International University, Service road, Gulberg expressway, block D, Gulberg greens Islamabad Capital Territory. Islamabad Pakistan
Postal code 44000
Country 126494 0
Pakistan
Phone 126494 0
+92 333 5992417
Fax 126494 0
Email 126494 0
kirankhushnood@yahoo.com
Contact person for public queries
Name 126495 0
Ms Kiran Khushnood
Address 126495 0
Riphah International University, Service road, Gulberg expressway, block D, Gulberg greens Islamabad Capital Territory. Islamabad Pakistan
Postal code 44000
Country 126495 0
Pakistan
Phone 126495 0
+92 333 5992417
Fax 126495 0
Email 126495 0
kirankhushnood@yahoo.com
Contact person for scientific queries
Name 126496 0
Ms Kiran Khushnood
Address 126496 0
Riphah International University, Service road, Gulberg expressway, block D, Gulberg greens Islamabad Capital Territory. Islamabad Pakistan
Postal code 44000
Country 126496 0
Pakistan
Phone 126496 0
+92 333 5992417
Fax 126496 0
Email 126496 0
kirankhushnood@yahoo.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data would be collected from a special education institute, which has the policy of not sharing subject's individual data. The detailed analysis of all variables will be shared after completion of study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.