Pelvic Neuromuscular Facilitation and Swiss Ball Exercises on Trunk Control in Children With Diaplegic CP
Primary Purpose
Cerebral Palsy
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Proprioceptive Neuromuscular Facilitation
Swiss Ball Exercises
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, Trunk Control Training, Proprioceptive Neuromuscular Facilitation Approach, Swiss ball, Trunk Control Measurement Scale.
Eligibility Criteria
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
Sites / Locations
- International Therapy Services CenterRecruiting
- Rising Sun InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Swiss Ball Exercises
Proprioceptive Neuromuscular Facilitation
Arm Description
Swiss ball exercises along with baseline treatment trunk twists,
pelvic neuromuscular facilitation techniques including various PNF movement patterns along with the baseline treatment
Outcomes
Primary Outcome Measures
Trunk Control Measurement Scale
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
GMFC
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05460923
First Posted
July 14, 2022
Last Updated
July 14, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05460923
Brief Title
Pelvic Neuromuscular Facilitation and Swiss Ball Exercises on Trunk Control in Children With Diaplegic CP
Official Title
Comparison of Pelvic Neuromuscular Facilitation and Swiss Ball Exercises on Trunk Control in Children With Diaplegic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
September 25, 2022 (Anticipated)
Study Completion Date
November 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral Palsy, Trunk Control Training, Proprioceptive Neuromuscular Facilitation Approach, Swiss ball, Trunk Control Measurement Scale.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Swiss Ball Exercises
Arm Type
Experimental
Arm Description
Swiss ball exercises along with baseline treatment trunk twists,
Arm Title
Proprioceptive Neuromuscular Facilitation
Arm Type
Experimental
Arm Description
pelvic neuromuscular facilitation techniques including various PNF movement patterns along with the baseline treatment
Intervention Type
Other
Intervention Name(s)
Proprioceptive Neuromuscular Facilitation
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Swiss Ball Exercises
Intervention Description
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
Primary Outcome Measure Information:
Title
Trunk Control Measurement Scale
Description
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
Time Frame
8th week
Title
GMFC
Description
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.
Time Frame
8th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wajiha shahid, phd
Phone
03214885079
Email
wajiha.shahid@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wajiha Shahid, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Therapy Services Center
City
Lahore
State/Province
Punjab
ZIP/Postal Code
40050
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wajiha shahid, phd
Phone
03036088768
Email
wajiha.shahid@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Sania Ahmad, MS (PPT)
Facility Name
Rising Sun Institute
City
Lahore
State/Province
Punjab
ZIP/Postal Code
40050
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wajiha shahid, phd
Phone
03036088768
Email
wajiha.shahid@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Sania Ahmad, MS (PPT)
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pelvic Neuromuscular Facilitation and Swiss Ball Exercises on Trunk Control in Children With Diaplegic CP
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