Pelvic Proprioceptive Neuromuscular Facilitation on Trunk Control and Balance

NCT05261048 | Unknown

• 1 other identifier: IRB-UOL-FAHS/1073/2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Spastic Hemiplegic Cerebral Palsy

Keywords

Unilateral cerebral palsy

Outcome Measures

Primary Outcomes (1)

• Trunk Impairment Scale

  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 Outcomes (1)

• Pediatric Balance Scale

  12 weeks

Study Arms (2)

Pelvic Proprioceptive neuromuscular facilitation in addition to Conventional Physical Therapy

EXPERIMENTAL

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; Other: Conventional Physical Therapy

Conventional Physical Therapy

PLACEBO COMPARATOR

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

Interventions

Pelvic Proprioceptive neuromuscular facilitation in addition to Conventional Physical Therapy 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.

Pelvic Proprioceptive neuromuscular facilitation in addition to Conventional Physical Therapy

Conventional Physical Therapy 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; Pelvic Proprioceptive neuromuscular facilitation in addition to Conventional Physical Therapy

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

Children Hospital

Faisalabad, Punjab/Muslim, 38000, Pakistan

RECRUITING

Related Publications (8)

• 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.

  PMID: 28715518 BACKGROUND

• 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.

  PMID: 29207820 BACKGROUND

• 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.

  PMID: 32662125 BACKGROUND

• 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.

  PMID: 28503533 BACKGROUND

• 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.

  PMID: 28905003 BACKGROUND

• 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.

  PMID: 29652201 BACKGROUND

• 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.

  PMID: 29991150 BACKGROUND

• 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.

  PMID: 20868877 BACKGROUND

Study Officials

• Saiqa Irum, MS PTN

  University of Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Haider Ullah khan, MS PTN

CONTACT

0092314127210; haiderullah@live.com

Ashfaq Ahmad, Phd

CONTACT

00923009449192; hod@uipt.uol.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (Outcome Assessor) Study will be single blinded. The assessor will be unaware of the treatment given to both groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2022
• First Posted: March 2, 2022
• Study Start: January 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 11, 2022
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)