Clinical trial NCT06461845: Whole Body Vibration Effect on Trunk Control, Functional Performance and Selective Control
Official title: Effect of Whole Body Vibration Effect on Trunk Control, Functional Performance and Selective Control of Lower Extremity in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Whole body vibration
cerebral palsy
trunk control
muscle performance
selective motor control
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 38
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Permanent neurological disorders such as cerebral palsy lead to problems with motor, sensory, and cognitive functions, which in turn limit one's ability to do certain activities. While the exact causes of cerebral palsy differ from child to child, anoxia-induced brain injury is a major cause of the disorder. The body parts affected, tone, and involuntary motions are used to categorise cerebral palsy. Among all the forms, spastic CP is the most prevalent. In individuals with CP, postural stabilisation and adaptations of the head, trunk, pelvic, and shoulder girdles grow more slowly. The primary problem with CP children is their gross movement pattern, which prevents them from performing single joint movements. Muscle strength increases significantly with WBV exercise training, which also reduces spasticity and enhances CP children's motor function. This study is important because it will determine whether WBV improves trunk control, functional performance, and lower limb selective control.

Data from Rising Sun Institute will be gathered for this randomised clinical trial. 38 patients will be included in the study. The study's inclusion criteria will include CP children with ages between 6 and 12 years old, those who can stand or walk alone (even with unusual gait patterns), GMFCS I and II, and children with diplegic cerebral palsy. Children with cerebral palsy (CP) who have had a lower limb fracture, fixed contracture, or other deformity, as well as those who have had a botulinum toxin injection or selective dorsal rhizotomy within the last six months, will not be eligible. Stretching exercises, strengthening exercises, trunk control facilitation, and rightening reaction facilitation will be the specific physical therapy treatments administered to group A. In addition, group B will receive WBV in addition to the specific physical therapy treatments (stretching exercises, strengthening exercises, trunk control facilitation, and rightening reaction facilitation). For two months, the 30-minute sessions will be held three times a week. The Modified Trost Test will test selective lower limb control, the PEDI scale will assess functional performance, and the Trunk Control Measurement Scale will monitor trunk stability before and after sessions. SPSS version 26 will be utilised for data analysis.


Eligibility criteria: Inclusion Criteria:

* • Childrens who follow verbal command

  * Childrens who can stand or walk alone (either with altered pattern)
  * Age limit: 6 -12 years
  * GMFCS I \& II
  * Diplegic Cerebral palsy

Exclusion Criteria:

* • Childrens with history of fracture in last 6 months

  * Childrens with fixed contracture or other deformity of lower limb
  * Childrens having visual or auditory impairments
  * Selective dorsal rhizotomy or botulinum toxin injection to lower extremities within past six months

Primary outcomes:
measure: .Trunk Control Measurement Scale (TCMS) for trunk control
timeFrame: Baseline to 8 weeks
measure: Modified Trost Test for selective control of lower extremity
timeFrame: Baseline to 8 weeks
measure: PEDI SCALE for functional performance
timeFrame: Baseline to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Pakistan Society for Rehabilitation of Disabled
Study officials:
affiliation: Riphah International University
name: Fareeha Kausar, PP-DPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Annino G, Alashram AR, Alghwiri AA, Romagnoli C, Messina G, Tancredi V, Padua E, Mercuri NB. Effect of segmental muscle vibration on upper extremity functional ability poststroke: A randomized controlled trial. Medicine (Baltimore). 2019 Feb;98(7):e14444. doi: 10.1097/MD.0000000000014444.
citation: Ali YMM, Elhadidy EI, Abdou RGE, Darwish SY. EFFECT OF WHOLE BODY VIBRATION ON QUADRICEPS MUSCLE PERFORMANCE IN HEMIPARETIC CHILDREN. 11. Ahmadizadeh Z, Khalili MA, Ghalam MS, Mokhlesin M. Effect of whole body vibration with stretching exercise on active and passive range of motion in lower extremities in children with cerebral palsy: A randomized clinical trial. Iranian Journal of Pediatrics. 2019;29(5)
citation: Telford D, Vesey RM, Hofman PL, Gusso S. The Effect of Vibration Therapy on Walking Endurance in Children and Young People With Cerebral Palsy: Do Age and Gross Motor Function Classification System Matter? Arch Rehabil Res Clin Transl. 2020 Jun 20;2(3):100068. doi: 10.1016/j.arrct.2020.100068. eCollection 2020 Sep.