- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06428552
To Evaluate the Efficacy of Mobile Applications in Tailoring and Enhancing Rehabilitation Interventions for Pediatric CP
May 20, 2024 updated by: Muhammad Naveed Babur, Superior University
To Evaluate the Efficacy of Mobile Applications in Tailoring and Enhancing Rehabilitation Interventions for Pediatric Patients With Cerebral Palsy
The world of technology is changing and becoming more advanced.
Children with cerebral palsy can benefit from the technology to enhance their mobility, balance, and coordination through mobile applications.
A lot of applications are made to offer games and interactive therapy activities that focus on balance, coordination, and motor skills.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
They may find these activities entertaining as well as helpful, which makes their rehabilitation more pleasurable.
This work builds on previous studies by making a mobile application that may be accessed from any location, giving therapeutic treatments more distribution flexibility.
This is especially helpful for those with cerebral palsy who might have mobility issues that make it challenging to consistently attend in-person therapy sessions.
Cerebral palsy children can perform organized exercises at home with the help of mobile application made for therapeutic activities and rehabilitation.
Therapeutic activities may be customized to meet the unique demands of each patient, guaranteeing that the treatment plan is in line with their capabilities and objectives.
Caregiver's involvement in the treatment process is a common element of app created specifically for people with cerebral palsy.
This might involve providing tools to enhance home-based care, educating caregivers through resources, and monitoring progress in order to promote a team-based approach to treatment.
Study Type
Interventional
Enrollment (Actual)
96
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Lahore, Pakistan
- Hope Rehabilitaion Centre, Mansoor Hospital Lahore , ChildRehab Sangla Hill
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Children with cerebral palsy
- Children aged between 5 to 16 years
Exclusion Criteria:
- Children with unstable epilepsy, chronic heart abnormalities , asthma , anemia and other medical conditions
- undergone botulinum neurotoxin A (BoNT-A)injections or surgery in the previous 2 months or 6 months respectively. "
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Usual care at home for 12 weeks
Daily rehabilitation program of 40 minutes duration using a mobile application to be completed 6 days per week for 12 weeks
|
Daily rehabilitation program of 40 minutes duration using a mobile application to be completed 6 days per week for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
questionnaire(QUIS)the application software
Time Frame: 12 Months
|
questionnaire(QUIS)the application software has been given to the intervention group and after using the software for one week, all participants answered the user satisfaction interaction questionnaire(QUIS).This step has taken to assess the software's usability based on feedback taken from parents or caregivers of patient with cerebral palsy and to assess the impact of utilizing this mobile application.
|
12 Months
|
|
Pedi Cat Questionnaire
Time Frame: 12 months
|
Pedi Cat Questionnaire To assess amount of recovery in patients with cerebral palsy, the intervention group answered valid and reliable Pedi Cat questionnaire at the first day of the study.
The intervention group used the content and rehabilitation protocol of the app under the supervision of therapist for 12 weeks at home.
After 12 weeks, the Pedi Cat questionnaire was answered by intervention group to assess recovery increasing or any change in the patients.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2023
Primary Completion (Actual)
May 1, 2024
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
May 20, 2024
First Submitted That Met QC Criteria
May 20, 2024
First Posted (Actual)
May 24, 2024
Study Record Updates
Last Update Posted (Actual)
May 24, 2024
Last Update Submitted That Met QC Criteria
May 20, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSRSW/Batch-Fall22/712
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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