Clinical trial NCT05261048: Pelvic Proprioceptive Neuromuscular Facilitation on Trunk Control and Balance
Official title: Effects of Pelvic Proprioceptive Neuromuscular Facilitation on Trunk Control and Balance in Children With Spastic Hemiplegic Cerebral Palsy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spastic Hemiplegic Cerebral Palsy
Keywords: Unilateral cerebral palsy
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Trunk Impairment Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Pediatric Balance Scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Children Hospital
state: Punjab/Muslim
Study officials:
affiliation: University of Lahore
name: Saiqa Irum, MS PTN
role: PRINCIPAL_INVESTIGATOR
References:
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