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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RPT Group | Active Comparator | 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 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine physical therapy | Other | Rehabilitation strategies in management of children with spastic CP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Ashworth scale (MAS) | 0 = No increase in muscle tone
| Twelve weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gross motor Function Measure (GMFM-88) | 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) | Twelve weeks |
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Inclusion Criteria:
Exclusion Criteria:
Children having moderate to severe contractures.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qamar Mahmood | Contact | Mahmood | qamarpt@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Qamar Mahmood | HOD, Physiotherapy Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Rehabilitation Medicine (NIRM) | Recruiting | Islamabad | Federal Capital | 44000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21273041 | Background | Kirby RS, Wingate MS, Van Naarden Braun K, Doernberg NS, Arneson CL, Benedict RE, Mulvihill B, Durkin MS, Fitzgerald RT, Maenner MJ, Patz JA, Yeargin-Allsopp M. Prevalence and functioning of children with cerebral palsy in four areas of the United States in 2006: a report from the Autism and Developmental Disabilities Monitoring Network. Res Dev Disabil. 2011 Mar-Apr;32(2):462-9. doi: 10.1016/j.ridd.2010.12.042. Epub 2011 Jan 26. | |
| 12600249 |
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| ID | Term |
|---|---|
| C537945 | Cerebral palsy, spastic, diplegic |
| D002547 | Cerebral Palsy |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000096262 | Medicine, Thai Traditional |
| ID | Term |
|---|---|
| D008519 | Medicine, Traditional |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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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.
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Outcome assessor will be kept blind about group allocation and identification of the participants before assessments at baseline, after 06 weeks and 12 weeks of intervention
| Traditional massage | Other | Rehabilitation strategies in management of children with spastic CP |
|
| Gross Motor Function Classification System (GMFCS) |
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 |
| Twelve weeks |
| CPCHILD ( Caregiver Priorities & child health index of life with Disabilities | 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. | Twelve weeks |
| Background |
| Reddihough DS, Collins KJ. The epidemiology and causes of cerebral palsy. Aust J Physiother. 2003;49(1):7-12. doi: 10.1016/s0004-9514(14)60183-5. |
| 16437058 | Background | Bhasin TK, Brocksen S, Avchen RN, Van Naarden Braun K. Prevalence of four developmental disabilities among children aged 8 years--Metropolitan Atlanta Developmental Disabilities Surveillance Program, 1996 and 2000. MMWR Surveill Summ. 2006 Jan 27;55(1):1-9. |
| 23672634 | Background | 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. |
| 12785436 | Background | Hurvitz EA, Leonard C, Ayyangar R, Nelson VS. Complementary and alternative medicine use in families of children with cerebral palsy. Dev Med Child Neurol. 2003 Jun;45(6):364-70. doi: 10.1017/s0012162203000707. |
| 23962350 | Background | 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. |
| 31488980 | Background | 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. |
| 25317927 | Background | 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. |
| 38427509 | Derived | Mahmood Q, Habibullah S, Aurakzai HU. Effectiveness of simple and basic home-based exercise programs including pediatric massage executed by caregivers at their homes in the management of children with spastic cerebral palsy: A randomized controlled trial. J Pediatr Rehabil Med. 2024;17(1):97-106. doi: 10.3233/PRM-220135. |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |