Clinical trial NCT05586191: Home Versus Hospital Based Action Observation Therapy in Diaplegic Cerebral Palsy
Official title: Effects of Home Versus Hospital Based Action Observation Therapy on Balance, Mobility and Cognition in Diaplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diplegic Cerebral Palsy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 46
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effects of Home Versus Hospital Based Action Observation Therapy on Balance, Mobility and Cognition in Diaplegic Cerebral Palsy. It will be a RCT we want to identify the effects of action observation therapy on patients coming to the hospital as compared to the patients at home. We will also identify the retaining effects of AOT. Our sample size will be 40 diplegic patients having no cognitive issues and able to walk with assistive device. We will exclude the patient who will suffer with severe comorbidities and visual impairment. We will randomly assign the patients into two groups A and B.A will receive Action observation therapy three times a day along with stretching exercises .while group B we perform AOT and stretching exercises at home with same frequency.


Eligibility criteria: Inclusion Criteria:

* Participants falling in this category will be recruited into the study.

  * Diagnosed Diaplegic CP Children between the age of 5 to 11 years.
  * Without visual impairment and visual field defects.
  * Able to follow the researcher's instruction.
  * GMFCS (gross motor function classification system) level I-III.

Exclusion Criteria:

* Participants failing to fall in this category will be excluded of the study.

  * Children with a Modified Ashworth scale (MAS) of 3 or more
  * Unable to walk
  * Children with severe co-morbidities. (2)

Primary outcomes:
measure: Gross Motor Function measure (GMFM)
timeFrame: 12 weeks
measure: Pediatric Balance Scale (PBS)
timeFrame: 12 weeks
measure: Timed 10 meter walk test
timeFrame: 12 weeks
measure: Mini-mental state pediatric examination (MMSPE)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Irfan General Hospital Peshawar
state: Khyberpakhtunkhuwa
Study officials:
affiliation: Riphah International University
name: Ayesha Bashir, MSNMPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeong YA, Lee BH. Effect of Action Observation Training on Spasticity, Gross Motor Function, and Balance in Children with Diplegia Cerebral Palsy. Children (Basel). 2020 Jun 18;7(6):64. doi: 10.3390/children7060064.
citation: Numanoglu A, Gunel MK. Intraobserver reliability of modified Ashworth scale and modified Tardieu scale in the assessment of spasticity in children with cerebral palsy. Acta Orthop Traumatol Turc. 2012;46(3):196-200. doi: 10.3944/aott.2012.2697.
citation: Kim Y, Lee BH. Clinical Usefulness of Child-centered Task-oriented Training on Balance Ability in Cerebral Palsy. J Phys Ther Sci. 2013 Aug;25(8):947-51. doi: 10.1589/jpts.25.947. Epub 2013 Sep 20.
citation: Reid SM, Carlin JB, Reddihough DS. Distribution of motor types in cerebral palsy: how do registry data compare? Dev Med Child Neurol. 2011 Mar;53(3):233-8. doi: 10.1111/j.1469-8749.2010.03844.x. Epub 2010 Dec 17.
citation: Joung HJ, Park J, Ahn J, Park MS, Lee Y. Effects of creative dance-based exercise on gait performance in adolescents with cerebral palsy. J Exerc Rehabil. 2020 Aug 25;16(4):332-343. doi: 10.12965/jer.2040384.192. eCollection 2020 Aug.
citation: Oskoui M, Coutinho F, Dykeman J, Jette N, Pringsheim T. An update on the prevalence of cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2013 Jun;55(6):509-19. doi: 10.1111/dmcn.12080. Epub 2013 Jan 24.
citation: Park EC, Hwangbo G. The effects of action observation gait training on the static balance and walking ability of stroke patients. J Phys Ther Sci. 2015 Feb;27(2):341-4. doi: 10.1589/jpts.27.341. Epub 2015 Feb 17.
citation: Ryan D, Fullen B, Rio E, Segurado R, Stokes D, O'Sullivan C. Effect of Action Observation Therapy in the Rehabilitation of Neurologic and Musculoskeletal Conditions: A Systematic Review. Arch Rehabil Res Clin Transl. 2021 Jan 27;3(1):100106. doi: 10.1016/j.arrct.2021.100106. eCollection 2021 Mar.