Clinical trial NCT05707052: Neck-Trunk Stabilization Exercises and Bobath Therapy Spastic Diplegic Cerebral Palsy
Official title: Comparative Effects of Neck-Trunk Stabilization Exercises and Bobath Therapy on Trunk Control and Upper Limb Function in Children With Spastic Diplegic Cerebral Palsy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy Spastic Diplegia
Keywords: Bobath; Cerebral palsy; Neck-Trunk Stabilization;
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 44
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Physiotherapy is widely used in the treatment of children with cerebral palsy. This study is conducted to identify the most appropriate physiotherapy approach. The purpose of the study is to compare two physical rehabilitation strategies i.e., Neck-trunk stabilization exercises and Bobath therapy, to investigate their effectiveness on trunk control and upper limb function. The aims of treatment are to influence muscle tone and improve postural alignment by specific handling technique.

Detailed description: The study will be a Randomized Clinical Trial conducted at the physiotherapy outpatient clinic of the tertiary care hospital in Sialkot, Idrees Hospital. Following the approval of the BASR, the study will be completed within six months. The sample will be taken using a non-probability convenient sampling technique, and the sample will be randomly divided into two groups. A sample size of 44 patients will be taken in this study. There will be two groups. Both groups will receive conventional therapy consisting of stretching, strengthening, range-of-motion exercises, positioning, and electrical stimulation. Group A: This group will receive Neck-Trunk Stabilization exercises. Group B: This group will receive Bobath therapy. The total intervention protocol will be given for six weeks' duration, with three sessions per week of about 45 minutes each. Outcome measures tools will be Segmental Assessment of Trunk Control (SATCo) and Manual Ability Classification System (MACS). Children with spastic diplegic cerebral palsy will be measured at baseline and after 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Children diagnosed with spastic diplegic cerebral palsy
* Children with score of GMFCS \[2\] \[3\] \[4\] levels(2, 16).
* Signed consent form from parents/guardians.

Exclusion Criteria:

* Children with visual impairments
* Children with major auditory impairments
* Children with previous orthopedic surgery and Botulium toxin-A injection at least for 6 months
* Children having pharmacological intervention for the inhibition of spasticity
* Contractures
* Uncontrolled seizures
* Focal spasticity

Primary outcomes:
measure: Segmental Assessment of Trunk Control (SATCo)
timeFrame: 4th week
measure: Manual Ability Classification System (MACS)
timeFrame: 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Sialkot
country: Pakistan
facility: Idrees Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Ali Raza, MS(OMPT)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ejraei N, Ozer AY, Aydogdu O, Turkdogan D, Polat MG. The effect of neck-trunk stabilization exercises in cerebral palsy: randomized controlled trial. Minerva Pediatr (Torino). 2021 Sep 30. doi: 10.23736/S2724-5276.21.06206-6. Online ahead of print.
citation: Acar G, Ejraei N, Turkdogan D, Enver N, Ozturk G, Aktas G. The Effects of Neurodevelopmental Therapy on Feeding and Swallowing Activities in Children with Cerebral Palsy. Dysphagia. 2022 Aug;37(4):800-811. doi: 10.1007/s00455-021-10329-w. Epub 2021 Jun 25.
citation: Desouzart G. Physiotherapy intervention according to the Bobath concept in a clinical case of cerebral palsy. Ortho Res Online J. 2018;3(4).
citation: Shin JW, Song GB, Ko J. The effects of neck and trunk stabilization exercises on cerebral palsy children's static and dynamic trunk balance: case series. J Phys Ther Sci. 2017 Apr;29(4):771-774. doi: 10.1589/jpts.29.771. Epub 2017 Apr 20.
citation: Shin JW, Song GB. The effects of neck and trunk stabilization exercises on upper limb and visuoperceptual function in children with cerebral palsy. J Phys Ther Sci. 2016 Nov;28(11):3232-3235. doi: 10.1589/jpts.28.3232. Epub 2016 Nov 29.