- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05460923
Pelvic Neuromuscular Facilitation and Swiss Ball Exercises on Trunk Control in Children With Diaplegic CP
July 14, 2022 updated by: Riphah International University
Comparison of Pelvic Neuromuscular Facilitation and Swiss Ball Exercises on Trunk Control in Children With Diaplegic Cerebral Palsy
Cerebral palsy is an umbrella term that covers a group of non-progressive motor impairment syndromes that are associated with abnormalities in the brain particularly during the early stages of its development.
CP usually involves a number of musculoskeletal and neurological problems they include spasticity, contractures, dystonia, abnormal growth, poor trunk control, and poor balance.
Poor trunk control leads to a disturbance in activities of daily living along with postural issues.
PNF techniques and Swiss ball exercises target the trunk muscles by stimulating the proprioceptors and by allowing maximum resistance to them respectively.
The aim of the study is to do a comparison of Pelvic neuromuscular facilitation techniques and Swiss ball exercises in improving trunk control in children with diplegic cerebral palsy.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The studies conducted in the past were focused on finding out the effect of proprioceptive neuromuscular facilitation techniques on the lower extremities of children suffering from diplegic cerebral palsy.
The effects of PNF on trunk control the children suffering from diplegic CP are nearly minimal.
In addition to PNF, the literature shows that studies have been conducted to find the effects of Swiss ball training exercise on trunk control of the post-stroke patients however there is very little research on the effects of Swiss ball training in children suffering from diplegic CP.
Even if the studies are conducted the time duration of the studies are not enough to gain the maximum outcomes.
Study Type
Interventional
Enrollment (Anticipated)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 40050
- Recruiting
- International Therapy Services Center
-
Principal Investigator:
- Sania Ahmad, MS (PPT)
-
Lahore, Punjab, Pakistan, 40050
- Recruiting
- Rising Sun Institute
-
Principal Investigator:
- Sania Ahmad, MS (PPT)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with no trunk control
- Age between 5-12 years
- Patients with diplegia
Exclusion Criteria:
- Patients with Cognitive impairment
- Patients with comorbidities
- Patients who are unable to follow instructions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Swiss Ball Exercises
Swiss ball exercises along with baseline treatment trunk twists,
|
trunk twists, supine to sit, knee to chest, crawling, and bridges.
Every session will be 45 minutes.
Patients will be given 5 sessions per week and the study will last for 12 months
|
|
Experimental: Proprioceptive Neuromuscular Facilitation
pelvic neuromuscular facilitation techniques including various PNF movement patterns along with the baseline treatment
|
including trunk twists, supine to sit, knee to chest, crawling, and bridges.
Every session will be 45 minutes.
Patients will be given 5 sessions per week and the study will last for 12 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trunk Control Measurement Scale
Time Frame: 8th week
|
The Trunk Control Measurement Scale is a clinical tool that is used in order to measure the trunk control.
The scale is used in the areas of assessment of non-vestibular balance and functional mobility
|
8th week
|
|
GMFC
Time Frame: 8th week
|
The Gross Motor Function Classification System or GMFCS is a 5 level clinical classification system that describes the gross motor function of people with cerebral palsy on the basis of self-initiated movement abilities.
|
8th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 25, 2022
Primary Completion (Anticipated)
September 25, 2022
Study Completion (Anticipated)
November 28, 2022
Study Registration Dates
First Submitted
July 14, 2022
First Submitted That Met QC Criteria
July 14, 2022
First Posted (Actual)
July 15, 2022
Study Record Updates
Last Update Posted (Actual)
July 15, 2022
Last Update Submitted That Met QC Criteria
July 14, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/22/0716
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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