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. |
Register:
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ISRCTN |
Last refreshed on:
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7 December 2020 |
Main ID: |
ISRCTN76366356 |
Date of registration:
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08/06/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Physical activity on prescription for children with cerebral palsy: a feasibility study
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Scientific title:
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Participation in physical activities for children with cerebral palsy: Feasibility and effectiveness of physical activity on prescription by measuring goal attainment, gross motor function and physical activity level. |
Date of first enrolment:
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20/09/2013 |
Target sample size:
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29 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN76366356 |
Study type:
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Interventional |
Study design:
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Single-centre non randomised feasibility study (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Katarina
Lauruschkus |
Address:
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Lund University
Box 157
22100
Lund
Sweden |
Telephone:
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+46 707 51 98 88 |
Email:
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katarina.lauruschkus@med.lu.se |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Children: 1. Aged 7-11 years at baseline 2. Diagnosis of cerebral palsy 3. Gross and fine motor, communicative and cognitive functions 4. From both rural areas and cities in the south of Sweden
Parents: 1. Aged 36-64 years 2. Parents of participating children
Exclusion criteria: Children: 1. Age younger than 7 years at baseline 2. Age older than 11 years at baseline
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cerebral palsy Nervous System Diseases Cerebral palsy
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Intervention(s)
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All participants take part in the physical activity on prescription (PAP) intervention. The PAP intervention consists of a written agreement between each child, their parents and the physiotherapist and is based on Motivational Interviewing (MI), Canadian Occupational Performance Measure (COPM) and Goal Attainment Scaling (GAS).
Two months are calculated for the baseline-measurements and the discussions for reaching the agreements. The baseline-measurements involve: 1. Questionnaires regarding socioeconomic and clinical characteristics 2. Questionnaires regarding the frequency of the child’s physical activities at school, leisure time and physiotherapy 3. Questionnaires regarding physical activity 4. Measurement of gross motor function and physical activity Each child participates after that in self-selected physical activities for six months.
The first follow-up is performed at eight months involves completion of questionnaires regarding the frequency of the child’s physical activities at school, leisure time and physiotherapy, questionnaires regarding physical activity and measurement of gross motor function and physical activity. The second follow-up is performed at 11 months, and involves completion of questionnaires regarding the frequency of the child’s physical activities at school, leisure time and physiotherapy, questionnaires regarding physical activity and measurement of physical activity. The total duration of the intervention is 11 months.
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Primary Outcome(s)
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Achievement of goals is assessed using Goal Attainment Scaling (GAS) at baseline, at 8 and 11 months.
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Secondary Outcome(s)
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1. Performance problems, concerns and issues around their physical activities are identified and the performance and satisfaction levels in self-care, productivity and leisure are assessed using the Canadian Occupational Performance Measure (COPM) at baseline, at 8 and 11 months. The performance and satisfaction levels are ranked and rated from the child’s perspective on a Visual Analogue Scale (VAS) 1-10. 2. Gross motor function is assessed using The Gross Motor Function Measure 66 (GMFM-66) at baseline and at 8 months 3. Frequency of the child’s physical activities at school, leisure time and physiotherapy are recorded according to the questionnaire used in the National Quality Registry and CP Follow-Up Programme at baseline, at 8 and 11 months 4. Time children spend being physically active each day with light, moderate or vigorous intensity and how much time the child spent sedentary during the last seven days is assessed using the International Physical Activity Questionnaire (IPAQ) at baseline, at 8 and 11 months 5. Physical activity is assessed using a triaxial accelerometer at baseline and 8 months 6. Activity information is assessed using time-use diaries at baseline and 8 months
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Secondary ID(s)
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LU-Dnr 2013/521
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Source(s) of Monetary Support
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Research Platform for Disability Studies in Rehabilitation, The Promobilia foundation (Stiftelsen Promobilia), Swedish National Association for Disabled Children and Young People (Riksförbundet för Rörelsehindrade Barn och Ungdomar)
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Ethics review
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Status:
Approval date:
Contact:
Regional Ethical Review Board at Lund University, 19/09/2013, ref: LU-Dnr 2013/521
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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15/11/2014 |
URL:
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