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

Not Applicable

Active, not recruiting

• Conditions: Cerebral Palsy
• Interventions: Combination Product: EKKO therapy; Diagnostic Test: Conservative Treatment

• Registration Number: NCT06568848
• Lead Sponsor: Superior University

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.

Study Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-05-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-21
• Last Update Submitted: 2024-08-21
• Study First Posted: 2024-08-23
• Last Update Posted: 2024-08-23
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exp Group	EKKO therapy	-
Control Group	Conservative Treatment	-

Primary Outcome Measures

Name	Time	Method
GMFM Scale	12 Months	improvement in gross motor function, measured using the GMFM scale. The scale evaluates various dimensions such as sitting, rolling, jumping, crawling, kneeling, walking, and running. Assessments will be conducted at three points: pre-evaluation (month 1), mid-evaluation (month 3), and post-evaluation (end of month 6).

Trial Locations

Locations (1)

Little angles home sailkot cantt aziz bhati shaheed road opposit junior aps; 🇵🇰 Sialkot, Punjab, Pakistan