Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637579
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Effects of Universal Exercise Unit Therapy With Task-oriented Training in CP Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Universal Exercise Unit Therapy With Task-oriented Training on Lower Extremity Gross Motor Function and Balance in Cerebral Palsy Children
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cerebral palsy is a problem that affects the development and motor skills caused by early non-progressive central nervous system damage Muscle rigidity spasticity fragility uncontrolled movement or a combination of these abnormalities characterized it Therapeutic usage of the universal exercise unit is common Also called a spider cage or monkey cage This device helps people with motor problems especially cerebral palsy This metal 3-dimensional contraption uses wires rubber bands pulleys weights and belts The goal is to engage the vestibular and proprioceptive systems which are necessary for balance coordination and awareness
Detailed Description:
A Randomized Clinical Trial RCT design will be employed conducted at the Sialkot Medical and Physiotherapy Center over 10 months following synopsis approval The anticipated sample size accounting for a 20 attrition rate will be 34 participants in each of the two study groups Group A will undergo Universal Exercise Unit UEU therapy along with task oriented training while Group B will receive task-oriented training for gross motor functioning The sampling technique will be Non-probability convenience sampling with inclusion criteria comprising children aged 5-15 diagnosed with spastic cerebral palsy of both genders and in stable health condition The data collection tools include the Gross Motor Function Measure 88 GMFM 88 Trunk Impairment Scale TIS and pediatric balance scale The analysis will be conducted using SPSS for Windows software version 25 Training sessions lasting 6 weeks will be conducted twice a week and data will be collected before and after each session The UEU therapy will focus on various movements facilitated by the equipment while the task-oriented training will be personalized targeting specific functional limitations through activities simulating daily tasks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None