Pelvic Proprioceptive Neuromuscular Facilitation on Trunk Control and Balance

March 5, 2022 updated by: University of Lahore

Effects of Pelvic Proprioceptive Neuromuscular Facilitation on Trunk Control and Balance in Children With Spastic Hemiplegic Cerebral Palsy: A Randomized Controlled Trial

The study will be randomized controlled trial. This study will be conducted in Children Hospital Pakistan. A sample size of 60 will be randomly allocated into two groups, (30 participants in each group), by lottery method.

  • The participants randomly allocated into control group A, will receive conventional physiotherapy in the form of truncal exercises, which consists of upper and lower part of the trunk in spine and sitting position for a total 30 minutes including rest periods in between, once in a day for 4 days per week.
  • Participants in experimental group B receive both conventional physiotherapy and Pelvic Proprioceptive Neuromuscular Facilitation for 30 minutes, once in a day, 4 days per week for 12 weeks.
  • The experimental group received anterior elevation-Posterior depression pattern with the techniques of Rhythmic initiation, Slow reversal and Stabilizing reversal.
  • Affected side of the pelvis was given these techniques for total 30 minutes with 15 minutes of pelvic PNF in one session with rest periods in between.
  • Baseline data will be collected at baseline, 6 weeks and 12 weeks during follow up through Trunk Impairment scale (TIS) and Pediatric balance scale (PBS).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  • Recruitment: Participants who met the inclusion/exclusion will be recruited from the outpatient Department of Pediatric Rehabilitation of the children hospital.
  • Screening: Participants will be considered eligible for entering the study with Gross motor function level 1 and 2 ( walk with or without limitation) and spasticity range between grade 1 and 2 according Modified Ashworth scale.
  • Gross Motor Function Classification System (GMFCS): Children who can walk independently without assistance are categorized into GMFCS levels I and II, whereas those who cannot walk independently and need assistance or gait assistive device for ambulation are categorized into levels III and V.
  • Modified Ashworth scale: It will be assessed while moving from extension to flexion scoring 0 No increase in tone. 1 slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension. 1+ slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM). 2 more marked increase in tone but more marked increased in muscle tone through most limb easily flexed. 3 considerable increase in tone, passive movement difficult. 4 limb rigid in flexion or extension
  • Randomization and allocation: Afterwards, participants will be conforming the eligibility criteria will be randomly allocated, through lottery method, into two experimental groups (Group A, Group B).
  • Blindness: The study will be single blinded. The assessor will be unaware of the treatment given to both groups.
  • Intervention: The participants randomly allocated to control group A, will receive conventional physical therapy in the form of truncal exercises, which consists of upper and lower part of the trunk in spine and sitting position for 30 minutes including rest intervals in between.
  • Participants in experimental group B, will receive pelvic proprioceptive neuromuscular facilitation in addition to conventional physical therapy for 30 minutes each, once in a day, 4 days per week for 12 weeks.
  • Duration: Forty eight sessions will be given over a period of 12 weeks for each session of 30 minutes.

  • Outcome Variables and measures:

    1. Trunk Control(Trunk Impairment scale (TIS)
    2. Balance (Pediatric balance scale (PBS)
  • Outcome measures will be taken at baseline, 6 weeks and 12 weeks during follow up.

Study Type

Interventional

Enrollment (Anticipated)

60

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 Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab/Muslim
      • Faisalabad, Punjab/Muslim, Pakistan, 38000
        • Recruiting
        • Children Hospital
        • Contact:
          • Faisal Rasool
          • Phone Number: 03332496289
        • Principal Investigator:
          • Saiqa Irum, MS PTN
        • Sub-Investigator:
          • Syed Asadullah Arsalan, Phd
        • Sub-Investigator:
          • Umair Ahmad, MSPTN

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:

  • Children diagnosed as Spastic hemiplegic cerebral palsy
  • Age group (5-12) years
  • Both male and female
  • Gross motor function level 1 and 2 ( walk with or without limitation)
  • Spasticity range between grade 1 and 2 according Modified Ashworth scale
  • Able to follow the simple verbal instructions.

Exclusion Criteria:

  • Children with visual, auditory, vestibular or perceptual deficit.
  • Any Fracture
  • Other neurological and cardio logical conditions( mental disorder, epilepsy, autism)
  • Cognitive impairments
  • Other types of CP

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pelvic Proprioceptive neuromuscular facilitation in addition to Conventional Physical Therapy

The experimental group received both conventional and Pelvic PNF for 30 minutes each, once in a day, 4 days per week.

The experimental group will be given anterior elevation-Posterior depression pattern with the techniques of Rhythmic initiation, Slow reversal and Stabilizing reversal.

These techniques will be given on affected side for total 30 minutes with 15 minutes of pelvic PNF in one session with rest periods in between.

Participants will be positioned into side lying with both hip flexion 1000 and knee flexion 450, neck supported by a pillow with flexion of 300.

Hand placement for anterior elevation over the crest of the ilium one hand overlaps other for posterior depression heel of the one hand hold with other hand on the ischial tuberosity.

"Pull up" and "Push down" command will be given along with the techniques of rhythmic initiation, slow reversal and stabilizing reversal.
Other: Pelvic Proprioceptive neuromuscular facilitation in addition to Conventional Physical Therapy

The experimental group received both conventional and Pelvic PNF for 30 minutes each, once in a day, 4 days per week. The experimental group will be given anterior elevation-Posterior depression pattern with the techniques of Rhythmic initiation, Slow reversal and Stabilizing reversal. These techniques will be given on affected side for total 30 minutes with 15 minutes of pelvic PNF in one session with rest periods in between. Participants will be positioned into side lying with both hip flexion 1000 and knee flexion 450, neck supported by a pillow with flexion of 300. Hand placement for anterior elevation over the crest of the ilium one hand overlaps other for posterior depression heel of the one hand hold with other hand on the ischial tuberosity.

"Pull up" and "Push down" command will be given along with the techniques of rhythmic initiation, slow reversal and stabilizing reversal.

Other: Conventional Physical Therapy

Conventional physiotherapy will be asked to perform truncal exercises in spine and sitting position for total 30 minutes including rest periods in between, once in a day for 4 days per week.

Exercises in supine position included (pelvic bridging, unilateral pelvic bridging, upper trunk rotation (clasped hand), lower trunk rotation (crook lying) with 3 repetitions for each exercise.

In sitting position, exercises included flexion and extension of lower trunk, rotation of upper and lower trunk, forward and lateral reach with 3 repetitions for each exercise.
PLACEBO_COMPARATOR: Conventional Physical Therapy

Patient will perform conventional physiotherapy in form of truncal exercises, which consist of upper and lower part of trunk in spine and sitting position for total 30 minutes and then participants will be asked to take some rest. In supine position, pelvic bridging, unilateral pelvic bridging, upper trunk rotation (clasped hand), lower trunk rotation (crook lying) with 3 repetitions for each exercise.

In sitting position, exercises included flexion and extension of lower trunk, rotation of upper and lower trunk, forward and lateral reach with 3 repetitions for each exercise.
Other: Conventional Physical Therapy

Conventional physiotherapy will be asked to perform truncal exercises in spine and sitting position for total 30 minutes including rest periods in between, once in a day for 4 days per week.

Exercises in supine position included (pelvic bridging, unilateral pelvic bridging, upper trunk rotation (clasped hand), lower trunk rotation (crook lying) with 3 repetitions for each exercise.

In sitting position, exercises included flexion and extension of lower trunk, rotation of upper and lower trunk, forward and lateral reach with 3 repetitions for each exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trunk Impairment Scale
Time Frame: 12 weeks
It is used to assess trunk control including static and dynamic-sitting balance, and upper and lower trunk coordination during trunk rotation while sitting. Each item was graded on a 2-4-point ordinal scale. The highest possible scores for the static- and dynamic-sitting balance tests, and the trunk coordination test were 7, 10, and 6, and the total TIS score ranged from 0 to 23. Each item of the TIS was tested three times and the highest score counted. No practice was allowed.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Balance Scale
Time Frame: 12 weeks
Pediatric Balance Scale that is a modified version of the Berg Balance Scale. It is used to assess functional balance skills in school-aged children, from typically developing children and children with motor impairments. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lahore

Investigators

  • Principal Investigator: Saiqa Irum, MS PTN, University of Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2021

Primary Completion (ANTICIPATED)

June 1, 2022

Study Completion (ANTICIPATED)

June 11, 2022

Study Registration Dates

First Submitted

February 12, 2022

First Submitted That Met QC Criteria

February 19, 2022

First Posted (ACTUAL)

March 2, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 5, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-UOL-FAHS/1073/2021

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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