Clinical trial NCT05111236: Potential Benefits of Home Based Exercise Programs in the Management of Spastic Cerebral Palsy
Official title: Potential Benefits of Home Based Exercise Programs With and Without Traditional Massage in the Management of Spastic Cerebral Palsy: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy, Spastic, Diplegic
Keywords: cerebral palsy, massage, spasticity, motor function
Lead sponsor: National Institute of Rehabilitation Medicine, Islamabad, Pakistan
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 86
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a RCT with two groups, RPT and Massage. Both groups will receive routine physical therapy (with addition of traditional massage in Massage group only) five days a week for a period of 12 weeks.
Primary purpose: TREATMENT

Brief summary: The study will be conducted to see the potential benefits of home based exercise program comprising routine physical therapy and traditional massage in the management of spastic cerebral palsy (CP). It will be a randomized controlled trial having two groups, RPT group and Massage group. Both groups will be provided with routine physical therapy treatment comprising stretching of spastic muscles, strengthening of weak muscles, positioning and posturing strategies. Massage group will also receive traditional massage in addition to routine physical therapy. Parents/Caregivers will be trained to perform routine physical therapy and traditional massage at home. Data will collected using a structured questionnaire, Modified Ashworth Scale (MAS), Gross Motor Function Measure (GMFM),Gross Motor Function Classification System (GMFCS) and CP Child's Caregiver Priorities \& Child Health Index of Life with Disabilities at baseline, after 6th and 12th weeks of intervention.

Detailed description: CP is among the most common type of physical disabilities presenting itself in children across the globe. Although its incidence range has been reported from 2 to 2.5 cases per 1000 live births globally, however it may be many folds in poor counties due to lack of reporting and absence of CP registries at national level . Many interventions are in use to manage the disabling and lifelong consequences of this condition. However majority of these interventions remain beyond the reach of poor population especially in under developed countries with poor socio-economic status like Pakistan. This creates a need for search to such interventions which should be locally available, accessible, low cost, affordable, and doable by the poor population so that disabling consequences of this condition may be minimized. RPT and traditional massage performed by parents at home after proper training fall in the category of such low cost interventions. Hence there is dire need to investigate the potential benefits of such interventions. That is why this RCT has been planned.

Eligibility criteria: Inclusion Criteria:

* Child should have established diagnosis of spastic cerebral palsy (diplegic types only).

Exclusion Criteria:

* Children having moderate to severe contractures.

  * Children having moderate to severe mental retardation and with multiple disabilities.
  * Children with Attention Deficit Hyperactive Disorder (ADHD), uncontrolled seizures and behavioral disorders

Primary outcomes:
measure: Modified Ashworth scale (MAS)
timeFrame: Twelve weeks
Secondary outcomes:
measure: Gross motor Function Measure (GMFM-88)
timeFrame: Twelve weeks
measure: Gross Motor Function Classification System (GMFCS)
timeFrame: Twelve weeks
measure: CPCHILD ( Caregiver Priorities & child health index of life with Disabilities
timeFrame: Twelve weeks
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: National Institute of Rehabilitation Medicine (NIRM)
state: Federal Capital
Study officials:
affiliation: HOD, Physiotherapy Department
name: Qamar Mahmood
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Reddihough DS, Jiang B, Lanigan A, Reid SM, Walstab JE, Davis E. Social outcomes of young adults with cerebral palsy. J Intellect Dev Disabil. 2013 Sep;38(3):215-22. doi: 10.3109/13668250.2013.788690. Epub 2013 May 14.
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citation: Novak I, McIntyre S, Morgan C, Campbell L, Dark L, Morton N, Stumbles E, Wilson SA, Goldsmith S. A systematic review of interventions for children with cerebral palsy: state of the evidence. Dev Med Child Neurol. 2013 Oct;55(10):885-910. doi: 10.1111/dmcn.12246. Epub 2013 Aug 21.
citation: Mahmood Q, Habibullah S, Babur MN. Potential effects of traditional massage on spasticity and gross motor function in children with spastic cerebral palsy: A randomized controlled trial. Pak J Med Sci. 2019 Sep-Oct;35(5):1210-1215. doi: 10.12669/pjms.35.5.478.
citation: Novak I, Berry J. Home program intervention effectiveness evidence. Phys Occup Ther Pediatr. 2014 Nov;34(4):384-9. doi: 10.3109/01942638.2014.964020. Epub 2014 Oct 15. No abstract available.