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Clinical Trials/NCT05111236
NCT05111236
Unknown
N/A

Potential Benefits of Home Based Exercise Programs With and Without Traditional Massage in the Management of Spastic Cerebral Palsy: A Randomized Controlled Trial.

National Institute of Rehabilitation Medicine, Islamabad, Pakistan1 site in 1 country86 target enrollmentNovember 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cerebral Palsy, Spastic, Diplegic
Sponsor
National Institute of Rehabilitation Medicine, Islamabad, Pakistan
Enrollment
86
Locations
1
Primary Endpoint
Modified Ashworth scale (MAS)
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
June 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Institute of Rehabilitation Medicine, Islamabad, Pakistan
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Modified Ashworth scale (MAS)

Time Frame: Twelve weeks

0 = No increase in muscle tone * 1 = Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension * 1+ = Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the Range Of Motion (ROM) * 2 = More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved * 3 = Considerable increase in muscle tone, passive movement difficult. * 4 = Affected part(s) rigid in flexion or extension

Secondary Outcomes

  • Gross Motor Function Classification System (GMFCS)(Twelve weeks)
  • CPCHILD ( Caregiver Priorities & child health index of life with Disabilities(Twelve weeks)
  • Gross motor Function Measure (GMFM-88)(Twelve weeks)

Study Sites (1)

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