Clinical Trials Directory

Trials / Unknown

UnknownNCT05261048

Pelvic Proprioceptive Neuromuscular Facilitation on Trunk Control and Balance

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
University of Lahore · Academic / Other
Sex
All
Age
5 Years – 12 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERPelvic Proprioceptive neuromuscular facilitation in addition to Conventional Physical TherapyThe 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.
OTHERConventional Physical TherapyConventional 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.

Timeline

Start date
2021-01-01
Primary completion
2022-06-01
Completion
2022-06-11
First posted
2022-03-02
Last updated
2022-03-18

Locations

1 site across 1 country: Pakistan

Source: ClinicalTrials.gov record NCT05261048. Inclusion in this directory is not an endorsement.