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NCT Number: NCT06568848

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

"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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

5 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Sialkot, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EKKO therapy

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

Conservative Treatment

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

Primary outcomes

  1. GMFM Scale

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 23, 2024
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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