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Potential Benefits of Home Based Exercise Programs in the Management of Spastic Cerebral Palsy (HEP&CP)

Primary Purpose

Cerebral Palsy, Spastic, Diplegic

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Routine physical therapy
Traditional massage
Sponsored by
National Institute of Rehabilitation Medicine, Islamabad, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy, Spastic, Diplegic focused on measuring cerebral palsy, massage, spasticity, motor function

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Institute of Rehabilitation Medicine (NIRM)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

RPT Group

Massage Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Modified Ashworth scale (MAS)
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

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)
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
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.

Full Information

First Posted
October 28, 2021
Last Updated
January 4, 2022
Sponsor
National Institute of Rehabilitation Medicine, Islamabad, Pakistan
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1. Study Identification

Unique Protocol Identification Number
NCT05111236
Brief Title
Potential Benefits of Home Based Exercise Programs in the Management of Spastic Cerebral Palsy
Acronym
HEP&CP
Official Title
Potential Benefits of Home Based Exercise Programs With and Without Traditional Massage in the Management of Spastic Cerebral Palsy: A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Rehabilitation Medicine, Islamabad, Pakistan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic, Diplegic
Keywords
cerebral palsy, massage, spasticity, motor function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RPT Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Massage Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Routine physical therapy
Intervention Description
Rehabilitation strategies in management of children with spastic CP
Intervention Type
Other
Intervention Name(s)
Traditional massage
Intervention Description
Rehabilitation strategies in management of children with spastic CP
Primary Outcome Measure Information:
Title
Modified Ashworth scale (MAS)
Description
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
Time Frame
Twelve weeks
Secondary Outcome Measure Information:
Title
Gross motor Function Measure (GMFM-88)
Description
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)
Time Frame
Twelve weeks
Title
Gross Motor Function Classification System (GMFCS)
Description
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
Time Frame
Twelve weeks
Title
CPCHILD ( Caregiver Priorities & child health index of life with Disabilities
Description
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.
Time Frame
Twelve weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qamar Mahmood
Phone
Mahmood
Email
qamarpt@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qamar Mahmood
Organizational Affiliation
HOD, Physiotherapy Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Rehabilitation Medicine (NIRM)
City
Islamabad
State/Province
Federal Capital
ZIP/Postal Code
44000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qamar Mahmood, PhD
Phone
+923335151063
Email
qamarpt@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21273041
Citation
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.
Results Reference
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PubMed Identifier
12600249
Citation
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.
Results Reference
background
PubMed Identifier
16437058
Citation
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. Erratum In: MMWR Morb Mortal Wkly Rep. 2006 Feb 3;55(4):105-6.
Results Reference
background
PubMed Identifier
23672634
Citation
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.
Results Reference
background
PubMed Identifier
12785436
Citation
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.
Results Reference
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PubMed Identifier
23962350
Citation
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.
Results Reference
background
PubMed Identifier
31488980
Citation
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.
Results Reference
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PubMed Identifier
25317927
Citation
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.
Results Reference
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Potential Benefits of Home Based Exercise Programs in the Management of Spastic Cerebral Palsy

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