MiTii: A randomised trial of novel web-based upper limb intervention for congenital hemiplegia

Category Primary study
Registry of TrialsANZCTR
Year 2011
INTERVENTION: MiTii (“Move it To improve it”) is an internet‐based multimodal therapy which combines upper‐limb training within the context of meaningful physical activity that can be accessed in children's homes. Inherent in this approach is the ability to scaffold visual perception skills and cognitive challenge, both important aspects of activity engagement and participation in a virtual training environment. The program is potentially cost effective as only three centre‐based therapists (Physiotherapist, Occupation Therapist, and psychologist) are required to provide initial assessment, goal setting and training for families and participating children. Each therapist then spends 30 minutes each week to remotely modify the individualised program. This current application proposes to test the efficacy of MiTii in a wait list randomised controlled trial. We propose to provide MiTii at an intensity of 30 minutes per day, 6 days/week for 20 weeks (total dose 60 hours). All children will therefore receive the therapy within 10 months of being randomised either to commence MiTii immediately or waitlisted for 20 weeks before receiving the same Mitii therapy as the Immediate invention group. Retention of effects will be tested at 10 months. As current therapy programs are resource intensive and time consuming it is important to determine if gains from MiTii are sustained over a 10 month period as this could offer a cost effective model of care, particularly for rural, remote and isolated children with CP. CONDITION: Congenital Hemiplegia Cerebral Palsy PRIMARY OUTCOME: Motor and Process Skills in daily living activities as demonstrated by a 0.5 logit score on the Assessment of Motor and Process Skills (AMPS) SECONDARY OUTCOME: Activity limitations (unimanual capacity and bimanual performance) by mean difference of 5 points on the Assisting Hand Assessment (AHA) and 10% decrease in time on the Jebsen‐Taylor Test of Hand Function (JTHF) Executive functioning (sustained attention, working memory and cognitive flexibility) Executive functioning in everyday life (measured by the BRIEF) Functioning and participation domains of quality of life (CP‐QOL‐child/CP‐QOL‐Teen) by 5 points on specified domains MiTii will be more cost‐effective compared with Usual Care as shown by resource use and effectiveness based on function (AMPs) and quality of life (CPQOL) MiTii will increase physical activity capability (measured using the functional strength assessments, walking tests and modified shuttle run test) and performance (measured using a physical activity questionnaire and accelerometers over >3 days) Neuroplasticity determined on the Motor Evoked Potential (MEP) curves using Transcranial Magnetic Stimulation (TMS) Occupational performance (COPM performance and satisfaction) by 2 points Participation (LIFE‐H) by 0.5 weighted score for categories of personal care, nutrition, education and recreation Visual perception (visual discrimination, visual memory and visual sequential memory) INCLUSION CRITERIA: i. Gross Motor Function Classification (GMFCS) I or II; Manual Abilities (MACs) I, II, III. ii. Sufficient co‐operation and cognitive understanding to perform the tasks and access the computer equipment; iii. Are able to attend 3 appointments in Brisbane for initial assessment/training and follow‐up assessments. iv. Able to access the internet at home (phone line or internet access). Note; laptops will be loaned for those require them and camera’s provided for all children with the treatment phase.
Epistemonikos ID: 88f95f0cc575522907cc149a6bf4cc6fd9306363
First added on: Aug 22, 2024