Pelvic Proprioceptive Neuromuscular Facilitation on Trunk Control and Balance

NCT ID: NCT05261048

Last Updated: 2022-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-06-11

Brief Summary

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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).

Detailed Description

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* 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.

Conditions

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Spastic Hemiplegic Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Single (Outcome Assessor) Study will be single blinded. The assessor will be unaware of the treatment given to both groups.

Study Groups

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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.

Group Type EXPERIMENTAL

Pelvic Proprioceptive neuromuscular facilitation in addition to Conventional Physical Therapy

Intervention Type OTHER

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.

Conventional Physical Therapy

Intervention Type OTHER

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.

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.

Group Type PLACEBO_COMPARATOR

Conventional Physical Therapy

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lahore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saiqa Irum, MS PTN

Role: PRINCIPAL_INVESTIGATOR

University of Lahore

Locations

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Children Hospital

Faisalabad, Punjab/Muslim, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Muhammad Haider Ullah khan, MS PTN

Role: CONTACT

0092314127210

Ashfaq Ahmad, Phd

Role: CONTACT

00923009449192

Facility Contacts

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Faisal Rasool

Role: primary

03332496289

References

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Novak I, Morgan C, Adde L, Blackman J, Boyd RN, Brunstrom-Hernandez J, Cioni G, Damiano D, Darrah J, Eliasson AC, de Vries LS, Einspieler C, Fahey M, Fehlings D, Ferriero DM, Fetters L, Fiori S, Forssberg H, Gordon AM, Greaves S, Guzzetta A, Hadders-Algra M, Harbourne R, Kakooza-Mwesige A, Karlsson P, Krumlinde-Sundholm L, Latal B, Loughran-Fowlds A, Maitre N, McIntyre S, Noritz G, Pennington L, Romeo DM, Shepherd R, Spittle AJ, Thornton M, Valentine J, Walker K, White R, Badawi N. Early, Accurate Diagnosis and Early Intervention in Cerebral Palsy: Advances in Diagnosis and Treatment. JAMA Pediatr. 2017 Sep 1;171(9):897-907. doi: 10.1001/jamapediatrics.2017.1689.

Reference Type BACKGROUND
PMID: 28715518 (View on PubMed)

Panibatla S, Kumar V, Narayan A. Relationship Between Trunk Control and Balance in Children with Spastic Cerebral Palsy: A Cross-Sectional Study. J Clin Diagn Res. 2017 Sep;11(9):YC05-YC08. doi: 10.7860/JCDR/2017/28388.10649. Epub 2017 Sep 1.

Reference Type BACKGROUND
PMID: 29207820 (View on PubMed)

Upadhyay J, Tiwari N, Ansari MN. Cerebral palsy: Aetiology, pathophysiology and therapeutic interventions. Clin Exp Pharmacol Physiol. 2020 Dec;47(12):1891-1901. doi: 10.1111/1440-1681.13379. Epub 2020 Aug 19.

Reference Type BACKGROUND
PMID: 32662125 (View on PubMed)

Sharma V, Kaur J. Effect of core strengthening with pelvic proprioceptive neuromuscular facilitation on trunk, balance, gait, and function in chronic stroke. J Exerc Rehabil. 2017 Apr 30;13(2):200-205. doi: 10.12965/jer.1734892.446. eCollection 2017 Apr.

Reference Type BACKGROUND
PMID: 28503533 (View on PubMed)

Stepien A, Fabian K, Graff K, Podgurniak M, Wit A. An immediate effect of PNF specific mobilization on the angle of trunk rotation and the Trunk-Pelvis-Hip Angle range of motion in adolescent girls with double idiopathic scoliosis-a pilot study. Scoliosis Spinal Disord. 2017 Sep 6;12:29. doi: 10.1186/s13013-017-0132-0. eCollection 2017.

Reference Type BACKGROUND
PMID: 28905003 (View on PubMed)

Kallem Seyyar G, Aras B, Aras O. Trunk control and functionality in children with spastic cerebral palsy. Dev Neurorehabil. 2019 Feb;22(2):120-125. doi: 10.1080/17518423.2018.1460879. Epub 2018 Apr 13.

Reference Type BACKGROUND
PMID: 29652201 (View on PubMed)

Kim DH, An DH, Yoo WG. Changes in trunk sway and impairment during sitting and standing in children with cerebral palsy. Technol Health Care. 2018;26(5):761-768. doi: 10.3233/THC-181301.

Reference Type BACKGROUND
PMID: 29991150 (View on PubMed)

Blair E. Epidemiology of the cerebral palsies. Orthop Clin North Am. 2010 Oct;41(4):441-55. doi: 10.1016/j.ocl.2010.06.004.

Reference Type BACKGROUND
PMID: 20868877 (View on PubMed)

Other Identifiers

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IRB-UOL-FAHS/1073/2021

Identifier Type: -

Identifier Source: org_study_id

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