Pelvic Neuromuscular Facilitation and Swiss Ball Exercises on Trunk Control in Children With Diaplegic CP

Sponsor

Riphah International University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05460923

Collaborator

(none)

Enrollment

Locations

Arms

6.1

Anticipated Duration (Months)

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy	Other: Proprioceptive Neuromuscular Facilitation Other: Swiss Ball Exercises	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Comparison of Pelvic Neuromuscular Facilitation and Swiss Ball Exercises on Trunk Control in Children With Diaplegic Cerebral Palsy

Actual Study Start Date :

May 25, 2022

Anticipated Primary Completion Date :

Sep 25, 2022

Anticipated Study Completion Date :

Nov 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Swiss Ball Exercises Swiss ball exercises along with baseline treatment trunk twists,	Other: Swiss Ball Exercises 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	Other: Proprioceptive Neuromuscular Facilitation 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

Arm

Intervention/Treatment

Experimental: Swiss Ball Exercises

Swiss ball exercises along with baseline treatment trunk twists,

Other: Swiss Ball Exercises

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

Other: Proprioceptive Neuromuscular Facilitation

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

Outcome Measures

Primary Outcome Measures

Trunk Control Measurement Scale [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
GMFC [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	International Therapy Services Center	Lahore	Punjab	Pakistan	40050
2	Rising Sun Institute	Lahore	Punjab	Pakistan	40050

Sponsors and Collaborators

Riphah International University

Investigators

Principal Investigator: Wajiha Shahid, PhD, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Riphah International University

ClinicalTrials.gov Identifier:

NCT05460923

Other Study ID Numbers:

REC/RCR & AHS/22/0716

First Posted:

Jul 15, 2022

Last Update Posted:

Jul 15, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Riphah International University

Cerebral Palsy, Trunk Control Training, Proprioceptive Neuromuscular Facilitation Approach, Swiss ball, Trunk Control Measurement Scale.

Additional relevant MeSH terms:

Cerebral Palsy

Study Results

No Results Posted as of Jul 15, 2022