## Protocol Section
### Identification Module
**NCT ID:** NCT06428552

**Brief Title:** To Evaluate the Efficacy of Mobile Applications in Tailoring and Enhancing Rehabilitation Interventions for Pediatric CP

**Official Title:** To Evaluate the Efficacy of Mobile Applications in Tailoring and Enhancing Rehabilitation Interventions for Pediatric Patients With Cerebral Palsy

#### Organization Study ID Info
**ID:** MSRSW/Batch-Fall22/712
#### Organization
**Class:** OTHER
**Full Name:** Superior University
### Status Module
#### Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-05-01

**Type:** ACTUAL

#### Start Date
**Date:** 2023-11-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Superior University

#### Responsible Party

**Investigator Affiliation:** Superior University

**Investigator Full Name:** Muhammad Naveed Babur

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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.

**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.

### Conditions Module

**Conditions:**

- Cerebral Palsy

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 96

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Daily rehabilitation program of 40 minutes duration using a mobile application to be completed 6 days per week for 12 weeks

**Intervention Names:**

- Device: Mobile Application

**Label:** Usual care at home for 12 weeks

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Usual care at home for 12 weeks

**Description:** Daily rehabilitation program of 40 minutes duration using a mobile application to be completed 6 days per week for 12 weeks

**Name:** Mobile Application

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** questionnaire(QUIS)the application software

**Time Frame:** 12 Months

**Description:** 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.

**Measure:** Pedi Cat Questionnaire

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** 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. "

**Maximum Age:** 16 Years

**Minimum Age:** 5 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Lahore

**Country:** Pakistan

**Facility:** Hope Rehabilitaion Centre, Mansoor Hospital Lahore , ChildRehab Sangla Hill

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001925

- Term: Brain Damage, Chronic

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5796

- Name: Cerebral Palsy

- Relevance: HIGH

- As Found: Cerebral Palsy

- ID: M13157

- Name: Paralysis

- Relevance: LOW

- As Found: Unknown

- ID: M5207

- Name: Brain Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M5202

- Name: Brain Damage, Chronic

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002547

- Term: Cerebral Palsy

### Misc Info Module

- Version Holder: 2024-05-31
