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Trial registered on ANZCTR


Registration number
ACTRN12616001013459
Ethics application status
Approved
Date submitted
20/06/2016
Date registered
1/08/2016
Date last updated
7/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Structured Home-Based Exercise Program for Ambulant Cerebral Palsy in Improving Ambulation Function
Scientific title
Structured Home-Based Exercise Program for Ambulant Cerebral Palsy in Improving Ambulation Function
Secondary ID [1] 289481 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 299166 0
Condition category
Condition code
Neurological 299181 299181 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 alternate sessions between flexibility and aerobic, and flexibility and strengthening for every. All session need to be supervised by parents or caregiver.

3) Intensity of exercise is monitored by parents using the OMNI-RPE scale (laminated), up to OMNI-RPE 6-7 (moderate intensity)

4) Equipments provided for participants, playground ball and step stool to perform aerobic exercises for upper and lower limbs respectively. Ankle & wrist weights (of 500g, 1 kg per pair) for performing strengthening exercise for upper and lower limbs respectively.

5) Exercise schedule:
Frequency of exercise - alternate combination of flexibility and aerobic AND flexibility and strengthening. Week 1&2 (2 days per week). Week 3&4 (3 times per week). Week 5,6,7 & 8 (4 times per week).
Duration- determines by how they achieve targeted intensity based on OMNI-RPE scale (6-7) for aerobic & strengthening exercises. Maximum aerobic exercise per session for both upper and lower limbs are 20 mins and maximum repetition of strengthening exercise is 8 repetitions each. For flexibility component, stretching of each specified areas of upper and lower limbs is advised for 15-30 seconds.

B. Personnel involve in delivering intervention
1) Physiotherapists - 2 physiotherapists involve in training participants and parents during familiarisation of home-based exercise and monitoring outcome using 6-minute walking test and GMFM-66 (component D&E). They are experienced in handling cerebral palsy children in Paediatric Rehabilitation service for at least 3 years.
2) Occupational therapist (OT) - 2 OTs are involved to monitor outcome in activities of daily living using Paediatric Evaluation Disability Inventory (PEDI). OT involve are experienced in paediatric rehabilitation service at least minimum of 3 years.
3) Investigators & Research assistant - involve in the planning of intervention program and monitoring the whole participation of participants in the assessment schedule and help with keeping records and tabulating research's data.

Intervention code [1] 295067 0
Treatment: Other
Comparator / control treatment
no comparator treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298664 0
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.

Timepoint [1] 298664 0
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
Primary outcome [2] 298907 0
2) Gross Motor Function Measure GMFM-66 (component D&E)
Timepoint [2] 298907 0
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
Secondary outcome [1] 324878 0
1) Activities of daily living in ambulation and hand function using Paediatric Evaluation of Disability Inventory (PEDI)
Timepoint [1] 324878 0
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
Secondary outcome [2] 324879 0
Children Assessment of Participation and Enjoyment (CAPE) questionnaire
Timepoint [2] 324879 0
Children Assessment of Participation and Enjoyment (CAPE) questionnaire will be assessed:

1) Once at baseline before intervention
2) Once post intervention at week 9th

Eligibility
Key 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
Minimum age
7 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Time series analysis will be performed to evaluate outcome pre and post intervention over time, using one-way repeated measures ANOVA

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/02/2016
Date of last participant enrolment
Anticipated
Actual
15/06/2016
Date of last data collection
Anticipated
30/09/2016
Actual
15/10/2016
Sample size
Target
19
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 7964 0
Malaysia
State/province [1] 7964 0
Kuala Lumpur, Federal Territory

Funding & Sponsors
Funding source category [1] 293844 0
University
Name [1] 293844 0
University Malaya Research Fund Assistance
Country [1] 293844 0
Malaysia
Primary sponsor type
University
Name
Institute of Research Management & Monitoring (IPPP), University of Malaya
Address
Institute of Research Management & Monitoring (IPPP)
Level 7, Research Management & Innovation Complex
University Malaya
50603 Kuala Lumpur
Federal Territory
Malaysia
Country
Malaysia
Secondary sponsor category [1] 292682 0
None
Name [1] 292682 0
none
Address [1] 292682 0
none
Country [1] 292682 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295285 0
Medical Ethics Committee, University Malaya Medical Center
Ethics committee address [1] 295285 0
Ethics committee country [1] 295285 0
Malaysia
Date submitted for ethics approval [1] 295285 0
25/08/2015
Approval date [1] 295285 0
18/01/2016
Ethics approval number [1] 295285 0
MECID.NO: 201581543

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64994 0
Dr Aishah Ahmad Fauzi
Address 64994 0
Department of Rehabilitation Medicine
Level 12, South Tower,
University Malaya Medical Centre,
50603 Kuala Lumpur, Federal Territory
Country 64994 0
Malaysia
Phone 64994 0
+60133417577
Fax 64994 0
Email 64994 0
aishahaf@ummc.edu.my
Contact person for public queries
Name 64995 0
Aishah Ahmad Fauzi
Address 64995 0
Department of Rehabilitation Medicine
Level 12, South Tower,
University Malaya Medical Centre,
50603 Kuala Lumpur, Federal Territory
Country 64995 0
Malaysia
Phone 64995 0
+60133417577
Fax 64995 0
Email 64995 0
aishahaf@ummc.edu.my
Contact person for scientific queries
Name 64996 0
Masyitah Mohd Khayat
Address 64996 0
Department of Rehabilitation Medicine
Level 12, South Tower
University Malaya Medical Centre
50603 Federal Territory, Kuala Lumpur
Country 64996 0
Malaysia
Phone 64996 0
+60126304290
Fax 64996 0
Email 64996 0
masyitahmkhayat@gmail.com

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No Supporting Document Provided



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