Pelvic Proprioceptive Neuromuscular Facilitation on Trunk Control and Balance

Spastic Hemiplegic Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05261048
• Other study ID #: IRB-UOL-FAHS/1073/2021
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: June 11, 2022

Study information

• Verified date: March 2022
• Source: University of Lahore
• Contact: Muhammad Haider Ullah khan, MS PTN
• Phone: 0092314127210
• Email: haiderullah[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 11, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Spastic Hemiplegic Cerebral Palsy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Pakistan	Children Hospital	Faisalabad	Punjab/Muslim

Sponsors (1)

Lead Sponsor	Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

References & Publications (8)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. Erratum in: JAMA Pediatr. 2017 Sep 1;171(9):919. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pediatric Balance Scale	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