Effects of EKKO Versus Conservative Treatment for Gross Motor Functions in Cerebral Palsy Patients

NCT ID: NCT06568848

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-10-30

Brief Summary

"Cerebral palsy (CP) affects gross motor function variably, with the spastic type notably impacting movement, coordination, and balance. Research highlights that spastic CP, characterized by muscle stiffness, can severely hinder activities like walking and running. Interventions such as gait training and vibrational therapy have shown promise in enhancing muscle function and body movements. A new device, EKKO, uses vibrational waves based on Neurotransmission Cognitive Theory to improve gross motor skills in children with CP by applying mechanical vibrations to nerve points.

Detailed Description

This study aims to compare the efficacy of EKKO therapy with traditional conservative treatments (such as range of motion exercises and balance training) in improving gross motor function in children with CP. Conducted over six months with randomized controlled trials, the research seeks to provide evidence-based insights into optimizing rehabilitation strategies for better motor performance and quality of life for CP patients.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Exp Group

Group Type: EXPERIMENTAL

EKKO therapy

Intervention Type: COMBINATION_PRODUCT

In this group 6 particepents will be included .the interventions will be given for 10 seconds on each finger tips . the session will be 30 mins. 4 to 5 sessions per week

Control Group

Group Type: ACTIVE_COMPARATOR

Conservative Treatment

Intervention Type: DIAGNOSTIC_TEST

In this group 6 participants will be included .: Conservative treatment, which includes ROM isometric exercises (20 repetitions per limb), stretching exercises (10 seconds per limb with 3 repetitions), balance training (standing without belts for 20 minutes), and gait training (walking with a frame). The session will be 30 mins

Interventions

EKKO therapy

In this group 6 particepents will be included .the interventions will be given for 10 seconds on each finger tips . the session will be 30 mins. 4 to 5 sessions per week

Intervention Type: COMBINATION_PRODUCT

Conservative Treatment

In this group 6 participants will be included .: Conservative treatment, which includes ROM isometric exercises (20 repetitions per limb), stretching exercises (10 seconds per limb with 3 repetitions), balance training (standing without belts for 20 minutes), and gait training (walking with a frame). The session will be 30 mins

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 1. cerebral palsy (CP)
• Severity: Typically applied to those with mild to moderate CP

Exclusion Criteria

• Participants without a confirmed diagnosis of cerebral palsy or any other neurological condition
• Severe cp cases may be excluded

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Superior University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Naveed Babur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Little angles home sailkot cantt aziz bhati shaheed road opposit junior aps

Sialkot, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

MSRSW/Batch-Fall22/739

Identifier Type: -

Identifier Source: org_study_id