Potential Benefits of Home Based Exercise Programs in the Management of Spastic Cerebral Palsy

NCT ID: NCT05111236

Last Updated: 2022-01-05

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

2021-11-01

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cerebral Palsy, Spastic, Diplegic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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

Study Groups

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RPT Group

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

Group Type ACTIVE_COMPARATOR

Routine physical therapy

Intervention Type OTHER

Rehabilitation strategies in management of children with spastic CP

Massage Group

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

Group Type EXPERIMENTAL

Routine physical therapy

Intervention Type OTHER

Rehabilitation strategies in management of children with spastic CP

Traditional massage

Intervention Type OTHER

Rehabilitation strategies in management of children with spastic CP

Interventions

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Routine physical therapy

Rehabilitation strategies in management of children with spastic CP

Intervention Type OTHER

Traditional massage

Rehabilitation strategies in management of children with spastic CP

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Rehabilitation Medicine, Islamabad, Pakistan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qamar Mahmood

Role: PRINCIPAL_INVESTIGATOR

HOD, Physiotherapy Department

Locations

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National Institute of Rehabilitation Medicine (NIRM)

Islamabad, Federal Capital, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Qamar Mahmood

Role: CONTACT

Facility Contacts

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Qamar Mahmood, PhD

Role: primary

+923335151063

References

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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)

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)

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)

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)

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)

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.

Reference Type BACKGROUND
PMID: 31488980 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25317927 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38427509 (View on PubMed)

Other Identifiers

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NIRM-Physio/01

Identifier Type: -

Identifier Source: org_study_id

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