NCT05460923

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

May 25, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2022

Completed
Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

4 months

First QC Date

July 14, 2022

Last Update Submit

July 14, 2022

Conditions

Keywords

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

Outcome Measures

Primary Outcomes (2)

  • 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

    8th week

  • 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.

    8th week

Study Arms (2)

Swiss Ball Exercises

EXPERIMENTAL

Swiss ball exercises along with baseline treatment trunk twists,

Other: Swiss Ball Exercises

Proprioceptive Neuromuscular Facilitation

EXPERIMENTAL

pelvic neuromuscular facilitation techniques including various PNF movement patterns along with the baseline treatment

Other: Proprioceptive Neuromuscular Facilitation

Interventions

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

Proprioceptive Neuromuscular Facilitation

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

Swiss Ball Exercises

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients with no trunk control
  • Age between 5-12 years
  • Patients with diplegia

You may not qualify if:

  • Patients with Cognitive impairment
  • Patients with comorbidities
  • Patients who are unable to follow instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

International Therapy Services Center

Lahore, Punjab Province, 40050, Pakistan

RECRUITING

Rising Sun Institute

Lahore, Punjab Province, 40050, Pakistan

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Wajiha Shahid, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2022

First Posted

July 15, 2022

Study Start

May 25, 2022

Primary Completion

September 25, 2022

Study Completion

November 28, 2022

Last Updated

July 15, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations