Potential Benefits of Home Based Exercise Programs in the Management of Spastic Cerebral Palsy
- Conditions
- Cerebral Palsy, Spastic, Diplegic
- Interventions
- Other: Routine physical therapyOther: Traditional massage
- Registration Number
- NCT05111236
- Lead Sponsor
- National Institute of Rehabilitation Medicine, Islamabad, Pakistan
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 86
- Child should have established diagnosis of spastic cerebral palsy (diplegic types only).
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RPT Group Routine physical therapy Routine physical therapy comprising stretching of spastic muscles, Strengthening of weak muscles, positioning ( how to make sitting and standing postures at home) and posturing strategies. This whole regimen will be practiced fives times a week for a period of twelve weeks. Other Names: • Routine Physical Therapy Massage Group Routine physical therapy Traditional massage of thirty minutes duration ( five minutes of massage will be provided to all four limbs, front and back of trunk area) prior to routine physical therapy. Routine physical therapy comprising stretching of spastic muscles, Strengthening of weak muscles, positioning ( how to make sitting and standing postures at home) and posturing strategies. Other Names: • Routine physical therapy and Traditional massage Massage Group Traditional massage Traditional massage of thirty minutes duration ( five minutes of massage will be provided to all four limbs, front and back of trunk area) prior to routine physical therapy. Routine physical therapy comprising stretching of spastic muscles, Strengthening of weak muscles, positioning ( how to make sitting and standing postures at home) and posturing strategies. Other Names: • Routine physical therapy and Traditional massage
- Primary Outcome Measures
Name Time Method Modified Ashworth scale (MAS) 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 Outcome Measures
Name Time Method Gross Motor Function Classification System (GMFCS) Twelve weeks It has five levels I to V showing the mobility level. Level I to III represent ambulatory status while IV and V represent Non- ambulatory status
CPCHILD ( Caregiver Priorities & child health index of life with Disabilities Twelve weeks It is used to check the quality of life of children with cerebral palsy. It has 09 sections to be completed representing different states related to quality of life.
Gross motor Function Measure (GMFM-88) Twelve weeks It is used to check the gross motor ability having total of 88 items to be checked in 05 different domain Lying and Rolling (total score 51), Sitting (Total score 60), Crawling and Kneeling( total 42), standing (total 39), walking running jumping (total 72)
Trial Locations
- Locations (1)
National Institute of Rehabilitation Medicine (NIRM)
🇵🇰Islamabad, Federal Capital, Pakistan