Pelvic Proprioceptive Neuromuscular Facilitation on Trunk Control and Balance

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

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

Conditions
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Spastic Hemiplegic Cerebral Palsy

Intervention / Treatment
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* Other: Pelvic Proprioceptive neuromuscular facilitation in addition to Conventional Physical Therapy
* Other: Conventional Physical Therapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pelvic Proprioceptive neuromuscular facilitation in addition to Conventional Physical Therapy<br>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<br>* 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.<br>Other: Conventional Physical Therapy<br>* 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.<br>|
| Placebo Comparator: Conventional Physical Therapy<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unilateral cerebral palsy