Clinical trial NCT04755556: Effectiveness of Routine Physical Therapy With Intensive Bimanual Training in Cerebral Palsy Children
Official title: Effectiveness of Routine Physical Therapy With or Without Home Based Intensive Bimanual Training on Clinical Outcomes in Cerebral Palsy Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Bimanual Training
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Home Based Intensive Bimanual training
Primary purpose: TREATMENT

Brief summary: Effectiveness of Routine Physical Therapy With or Without Home Based Intensive Bimanual Training on Clinical Outcomes in Cerebral Palsy Children

Detailed description: Cerebral Palsy is one of the most common issue seen in pediatric rehabilitation .Home based intensive Bimanual training has proven to be one of the most effective rehabilitation training for improving motor. The study determines the effectiveness of routine physical therapy with or without home-based intensive bimanual training on coordination of hands and daily activities of daily living. A nine months randomized control trial was comprised of thirty children with unilateral spastic cerebral palsy aged between 4 to 7 years. One group received routine physical therapy and the other group received a goal specific bimanual training from their parents in their home setting for 3.5 hours per week for 6 weeks according to a modified set up. Follow up sessions were done at 6th week. Activities of daily living and coordination were measured using Pediatric motor log activity scale and ABILHAND respectively.

Eligibility criteria: Inclusion Criteria:

* Spastic CP children

  * Both male and female
  * Age 4-7 years
  * Actively grasp of objects from table i.e., stuff toys, making blocks
  * One to one attention

Exclusion Criteria:

* Cognitive delays preventing the child from following two-step instructions

  * Health diagnoses unassociated with USCP.
  * Parents unable to commit to entire duration of intervention.
  * Visual difficulties preventing performance of intervention tasks.

Primary outcomes:
measure: ABILHAND
timeFrame: 6th week
Secondary outcomes:
measure: Pediatric Motor Log Activity Scale
timeFrame: 6th week
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of lahore
state: Punjab
Study officials:
affiliation: University of Lahore
name: Fatima Ejaz, MS-PT
role: PRINCIPAL_INVESTIGATOR
References:
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: Tronnes H, Wilcox AJ, Lie RT, Markestad T, Moster D. Risk of cerebral palsy in relation to pregnancy disorders and preterm birth: a national cohort study. Dev Med Child Neurol. 2014 Aug;56(8):779-85. doi: 10.1111/dmcn.12430. Epub 2014 Mar 13.
citation: Patel DR, Neelakantan M, Pandher K, Merrick J. Cerebral palsy in children: a clinical overview. Transl Pediatr. 2020 Feb;9(Suppl 1):S125-S135. doi: 10.21037/tp.2020.01.01.
citation: He P, Chen G, Wang Z, Guo C, Zheng X. Children with motor impairment related to cerebral palsy: Prevalence, severity and concurrent impairments in China. J Paediatr Child Health. 2017 May;53(5):480-484. doi: 10.1111/jpc.13444. Epub 2017 Jan 17.