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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12616001013459 |
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Date of registration:
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01/08/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Structured Home-Based Exercise Program for Ambulant Cerebral Palsy in Improving Ambulation Function
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Scientific title:
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Structured Home-Based Exercise Program for Ambulant Cerebral Palsy in Improving Ambulation Function |
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Date of first enrolment:
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08/02/2016 |
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Target sample size:
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19 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12616001013459.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Malaysia
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Contacts
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Name:
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Dr Masyitah Mohd Khayat
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Address:
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Department of Rehabilitation Medicine
Level 12, South Tower
University Malaya Medical Centre
50603 Federal Territory, Kuala Lumpur
Malaysia |
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Telephone:
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+60126304290 |
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Email:
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masyitahmkhayat@gmail.com |
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Affiliation:
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Name:
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Dr Aishah Ahmad Fauzi
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Address:
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Department of Rehabilitation Medicine
Level 12, South Tower,
University Malaya Medical Centre,
50603 Kuala Lumpur, Federal Territory
Malaysia |
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Telephone:
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+60133417577 |
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Email:
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aishahaf@ummc.edu.my |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1- Children with CP
2- Age 7-18 years old
3- GMFCS I-III
4- Received standard rehabilitation therapy
5- Able to follow at least 2 steps command
Exclusion criteria: 1- Unable to comprehend even 2 steps command
2- Not undergoing any rehabilitation therapy
3- Does not agree for participation in study
4- Received any surgical intervention or botulinum toxin injection last 3 months before study participation
5- Received home based private physiotherapy service
6- Staying far, outside Klang Valley
Age minimum:
7 Years
Age maximum:
18 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Cerebral Palsy ;
Cerebral Palsy
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Neurological - Other neurological disorders
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Intervention(s)
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Structured home-based exercise program which comprises flexibility, aerobic and strengthening therapy.
Information on structured home-based exercise program:
Familiarization - 4 sessions of home-based exercise taught at the physiotherapist gym to parents/caregiver and participants supervised by physiotherapist. This is done one month prior to the start of intervention.
a) duration of each session is 30 minutes up to 1 hr
b) frequency of sessions, once weekly
c) format - one to one session
Intervention duration - 8 weeks , structured home-based program delivered at home supervised by parents, using the provided logbook which has all details with pictures of exercises and timetable as guidance. Investigators will follow up and check on logbook timetable during every visits for assessment.
A. Materials & equipments during familiarization (training of exercise for 1 month before intervention started) and intervention ( 8 weeks home-based exercise program)
1) structured home-based exercise booklet which comprises flexibility, aerobic and strengthening therapy for both upper and lower limbs:
a. flexibility - stretching of muscles that crossed two joints of both upper and lower limb example; biceps, wrist flexors, hamstrings, gastrocnemius
b. Aerobic - for lower limb; moving up and down with ankle weights using stepping stool until achieved OMNI-RPE scale 6-7, for upper limb; throwing and playing balls until OMNI-RPE 6-7.
c. strengthening - Using free weights to move upper and lower limbs repetitively until achieve OMNI-RPE 6-7
2) A timetable of frequency gradually increase from twice to 4 times a week included in the booklet for parents to monitor the exercises done for total of 8 weeks - participants will a
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Primary Outcome(s)
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2) Gross Motor Function Measure GMFM-66 (component D&E) [Primary outcome measure will be assessed:
1) Every week for 1 month (4 weeks) before start of intervention as baseline measures
2) 3 times during intervention period (8 weeks) on 3rd, 6th and 9th week
3) 2 times post intervention at 1st month and 3rd month post intervention]
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6-minute walk test (6MWT) to assess walking speed and calculate the physiological cost index (PCI) which derived by walking HR-resting HR / walking speed
*HR is monitored during 6MWT by using a polar watch for paediatric population.
[Primary outcome measure will be assessed:
1) Every week for 1 month (4 weeks) before start of intervention as baseline measures
2) 3 times during intervention period (8 weeks) on 3rd, 6th and 9th week
3) 2 times post intervention at 1st month and 3rd month post intervention]
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Secondary Outcome(s)
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Children Assessment of Participation and Enjoyment (CAPE) questionnaire
[Children Assessment of Participation and Enjoyment (CAPE) questionnaire will be assessed:
1) Once at baseline before intervention
2) Once post intervention at week 9th
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1) Activities of daily living in ambulation and hand function using Paediatric Evaluation of Disability Inventory (PEDI)[PEDI will be assessed during the:
1) 3 times during intervention period (8 weeks) on 3rd, 6th and 9th week
2) 2 times post intervention at 1st month and 3rd month post intervention]
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Secondary ID(s)
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Nil known
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Source(s) of Monetary Support
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University Malaya Research Fund Assistance
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Ethics review
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Status: Approved
Approval date:
Contact:
Medical Ethics Committee, University Malaya Medical Center
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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