Effects of EKKO Versus Conservative Treatment for Gross Motor Functions in Cerebral Palsy Patients
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedFirst Submitted
Initial submission to the registry
August 21, 2024
CompletedFirst Posted
Study publicly available on registry
August 23, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2024
CompletedAugust 23, 2024
August 1, 2024
6 months
August 21, 2024
August 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
GMFM Scale
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).
12 Months
Study Arms (2)
Exp Group
EXPERIMENTALControl Group
ACTIVE COMPARATORInterventions
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
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
Eligibility Criteria
You may qualify if:
- \. cerebral palsy (CP)
- Severity: Typically applied to those with mild to moderate CP
You may not qualify if:
- Participants without a confirmed diagnosis of cerebral palsy or any other neurological condition
- Severe cp cases may be excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Little angles home sailkot cantt aziz bhati shaheed road opposit junior aps
Sialkot, Punjab Province, Pakistan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 21, 2024
First Posted
August 23, 2024
Study Start
November 1, 2023
Primary Completion
May 1, 2024
Study Completion
October 30, 2024
Last Updated
August 23, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share