A randomized, wait-list controlled trial of a physiotherapy and behaviour change intervention to increase physical activity through meaningful participation for children with cerebral palsy and their caregiver

Not Applicable

Completed

• Conditions: Cerebral Palsy; Physical Medicine / Rehabilitation - Physiotherapy; Neurological - Other neurological disorders

• Registration Number: ACTRN12615001064594
• Lead Sponsor: Sarah Reedman

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-13
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Participants are children with a diagnosis of Cerebral Palsy (GMFCS I-III, confirmed by the Child’s Paediatrician, Rehabilitation Physician, or Neurologist), aged between 8 and 12 years inclusive. The primary residence of the child during the study period is within 200kms of South Brisbane, Queensland.

Each included child’s primary caregiver (one person who has a long-term parenting role including a biological parent, step parent, adoptive parent or foster parent AND has at least 30% of caregiving responsibilities) is also a participant.

Exclusion Criteria

Children are excluded if they:
(1) Have limited ability to communicate insight into a preferred future (needs, wants and desires) in spoken English AND/OR through an interpreter or augmentative and alternative communication (i.e. Communication Function Classification System levels IV-V and/or children with moderate to severe intellectual disability)
(2) Have uncontrolled epilepsy (as this may impact on safety to engage in certain physical activities)
(3) Have a severe visual impairment or blindness (defined as 6/60 vision or lower, when appropriately corrected, in the better eye, or in the written opinion of an ophthalmologist the cortical visual impairment, visual field loss and/or other deficits result in a combined approximate acuity of 6/60 or lower)
(4) Have severe asthma exacerbated by exercise that is not controlled with medications under an asthma management plan
(5) Have orthopaedic and/or neurological surgery 6 months prior to and/or planned during the entire study period including follow-up assessments. Intramuscular botulinum toxin (BoNT-A) injections in the lower limbs and some minor surgeries may not automatically exclude entry

Caregivers are excluded if they:
(1) Have a diagnosed moderate to severe intellectual disability or significant communication impairment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physical activity participation incremental goal attainment: Goal Attainment Scaling (GAS)[Measured mid-intervention, immediate post-intervention (8 weeks), and follow-up (16 weeks). Primary timepoint is immediate post-intervention. GAS is subject to within group analyses only (will not be scored for the waitlist control group during the waitlist period).];Physical activity participation goal performance and satisfaction: Canadian Occupational Performance Measure (COPM)[Measured at baseline, immediate post-intervention (8 weeks), and follow-up (16 weeks). Primary timepoint is immediate post-intervention. ];Habitual Physical Activity Level: Minutes of Moderate to Vigorous Physical Activity per day, over 7 days (ActiGraph GT3x)[Measured at baseline, immediate post-intervention (8 weeks), and follow-up (16 weeks). Primary timepoint is immediate post-intervention. ]