The Effects of Traditional Massage on Spasticity and Activity of Children(2 to 10 Years) With Cerebral Palsy

NCT ID: NCT03771599

Last Updated: 2018-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2019-02-15

Brief Summary

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The study has been conducted to see the effects of traditional massage on spasticity and activity of children with cerebral palsy (CP). It is a randomized controlled trial having two groups, control and intervention. Both groups received routine physical therapy treatment comprising stretching of tight muscles, strengthening of weak muscles, positioning and handling. Intervention group also received traditional massage in addition to routine physical therapy. Caregivers were trained to perform routine physical therapy treatment and traditional massage at home. Data was collected using a structured questionnaire, Modified Ashworth Scale (MAS), Gross Motor Function Classification System (GMFCS), Gross Motor Function Measure (GMFM) and CPChild Caregiver Priorities \& Child Health Index of Life with Disabilities at baseline, after 06 weeks and 12 weeks of intervention.

Detailed Description

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Physical therapy is an important component of rehabilitation regimen which is commonly used in the management of children with CP. Massage is also used as a complimentary alternative medicine (CAM). It has many types being practiced across the globe. Traditional massage is a type of massage being practiced in a specific society and has its own way of execution. It does not need professional education, training and certification so do not have any financial burden on the caregivers. As Pakistan is a poor country with low socio-economic status, so such measures of management which involve less financial burden on caregivers need to be investigated.

In this RCT, traditional massage was performed on the participants in the supine lying position. Each upper and lower limb was massaged for five minutes with gentle rubbing in proximal to distal direction. Five minutes massage was also provided at front and back of trunk area each in center to periphery direction. This type of traditional massage is practiced in Pakistan population which is somewhat different to Swedish massage. In few previous studies effect of Swedish massage on spastic CP has been investigated with conflicting level of evidence. However no study has been conducted in Pakistan to see the effects of traditional massage on children with cerebral palsy.

Conditions

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Cerebral Palsy, Spastic, Diplegic

Keywords

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cerebral palsy, traditional massage, spasticity, children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It is a RCT with two groups, control and intervention. Both groups received routine physical therapy five days a week for a period of three months. Intervention group also received traditional massage for thirty minutes before start of the routine physical therapy. Data was collected at baseline, after 06 weeks and 12 weeks of intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
outcome assessor was kept blind about group identification of the participants before assessments at baseline, after 06 weeks and 12 weeks of intervention.

Study Groups

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Control group

Routine physical therapy

\[Time Frame: Twelve weeks\]

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type OTHER

Routine physical therapy comprising stretching of tight muscles ( stretch each muscle for five times with hold time of twenty seconds), Strengthening of weak muscles (perform resisted exercises ten times for each weak muscle), positioning ( how to make sitting and standing postures at home). This whole regimen was to be practiced fives times a week for a period of twelve weeks.

Intervention group

Traditional massage + Routine physical therapy

\[Time Frame: Twelve weeks\]

Group Type EXPERIMENTAL

Intervention Group

Intervention Type OTHER

Traditional massage of thirty minutes duration ( five minutes of massage was provided to all four limbs, front and back of trunk area) prior to routine physical therapy.

Routine physical therapy comprising stretching of tight muscles ( stretch each muscle for five times with hold time of twenty seconds), Strengthening of weak muscles (perform resisted exercises ten times for each weak muscle), positioning ( how to make sitting and standing postures at home). This whole regimen was to be practiced fives times a week for a period of twelve weeks.

Interventions

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Intervention Group

Traditional massage of thirty minutes duration ( five minutes of massage was provided to all four limbs, front and back of trunk area) prior to routine physical therapy.

Routine physical therapy comprising stretching of tight muscles ( stretch each muscle for five times with hold time of twenty seconds), Strengthening of weak muscles (perform resisted exercises ten times for each weak muscle), positioning ( how to make sitting and standing postures at home). This whole regimen was to be practiced fives times a week for a period of twelve weeks.

Intervention Type OTHER

Control group

Routine physical therapy comprising stretching of tight muscles ( stretch each muscle for five times with hold time of twenty seconds), Strengthening of weak muscles (perform resisted exercises ten times for each weak muscle), positioning ( how to make sitting and standing postures at home). This whole regimen was to be practiced fives times a week for a period of twelve weeks.

Intervention Type OTHER

Other Intervention Names

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Routine physical therapy and Traditional massage Routine Physical Therapy

Eligibility Criteria

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Inclusion Criteria

* Child should have diagnosis of spastic cerebral palsy (hemiplegic and 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
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Isra University

OTHER

Sponsor Role lead

Responsible Party

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Qamar Mehmood

Senior Physiotherapist & Head of Physiotherapy Department NIRM

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Isra University

Islamabad, Federal, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Qamar Mehmood, PHD*

Role: CONTACT

Phone: +923335151063

Email: [email protected]

Facility Contacts

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Qamar Mehmood, PHD*

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 12600249 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21273041 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16437058 (View on PubMed)

Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.

Reference Type BACKGROUND
PMID: 17370477 (View on PubMed)

Paneth N, Hong T, Korzeniewski S. The descriptive epidemiology of cerebral palsy. Clin Perinatol. 2006 Jun;33(2):251-67. doi: 10.1016/j.clp.2006.03.011.

Reference Type BACKGROUND
PMID: 16765723 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23672634 (View on PubMed)

Goodman M, Rothberg AD, Houston-McMillan JE, Cooper PA, Cartwright JD, van der Velde MA. Effect of early neurodevelopmental therapy in normal and at-risk survivors of neonatal intensive care. Lancet. 1985 Dec 14;2(8468):1327-30. doi: 10.1016/s0140-6736(85)92626-1.

Reference Type BACKGROUND
PMID: 2415788 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12785436 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23962350 (View on PubMed)

Other Identifiers

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IIRS-IUISB/PHD/002

Identifier Type: -

Identifier Source: org_study_id