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A protocol for a single-arm interventional study assessing the effects of a home-based joystick-operated ride-on-toy navigation training programme to improve affected upper extremity function and spontaneous use in children with unilateral cerebral palsy (UCP)

IntroductionChildren with unilateral cerebral palsy (UCP) face significant limitations in upper extremity (UE) function and require effective interventions that promote intensive goal-directed practice while maximising motivation and adherence with therapy. This study builds on our past work and wil...

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Published in:BMJ open 2023-05, Vol.13 (5), p.e071742-e071742
Main Authors: Shahane, Vaishnavi, Kumavor, Patrick, Morgan, Kristin, Friel, Kathleen M, Srinivasan, Sudha Madhav
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creator Shahane, Vaishnavi
Kumavor, Patrick
Morgan, Kristin
Friel, Kathleen M
Srinivasan, Sudha Madhav
description IntroductionChildren with unilateral cerebral palsy (UCP) face significant limitations in upper extremity (UE) function and require effective interventions that promote intensive goal-directed practice while maximising motivation and adherence with therapy. This study builds on our past work and will assess the effects of a 6-week researcher-caregiver codelivered, home-based ride-on-toy navigation training (RNT) programme in young children with UCP. We hypothesise that the RNT programme will be acceptable, feasible to implement, and lead to greater improvements in unimanual and bimanual function when combined with conventional therapy, compared with conventional therapy provided alone.Methods and analysis15 children with UCP between 3 and 8 years will be recruited. During the 6-week control phase, participants will receive treatement-as-usual alone. During the subsequent 6-week intervention phase, in addition to conventional therapy, RNT will be provided 4–5 times/week (2 times by researchers, 2–3 times by caregivers), 30–45 min/session. We will assess UE function using standardised tests (Quality of Upper Extremity Skills Test and Shriner’s Hospital Upper Extremity Evaluation), reaching kinematics, wrist-worn accelerometry, caregiver-rated ABILHAND-Kids questionnaire, and training-specific measures of movement control during RNT. Programme feasibility and acceptance will be assessed using device use metrics, child and caregiver exit questionnaires, training-specific measures of child engagement, and the Physical Activity Enjoyment Scale. All assessments will be conducted at pretest, following the control phase (midpoint), and after completion of the intervention phase (post-test).Ethics and disseminationThe study is approved by the Institutional Review Board of the University of Connecticut (# H22-0059). Results from this study will be disseminated through peer-reviewed manuscripts in scientific journals in the field, through national and international conferences, and through presentations to parent advocacy groups and other support organisations associated with CP.Trial registration numberNCT05559320.
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This study builds on our past work and will assess the effects of a 6-week researcher-caregiver codelivered, home-based ride-on-toy navigation training (RNT) programme in young children with UCP. We hypothesise that the RNT programme will be acceptable, feasible to implement, and lead to greater improvements in unimanual and bimanual function when combined with conventional therapy, compared with conventional therapy provided alone.Methods and analysis15 children with UCP between 3 and 8 years will be recruited. During the 6-week control phase, participants will receive treatement-as-usual alone. During the subsequent 6-week intervention phase, in addition to conventional therapy, RNT will be provided 4–5 times/week (2 times by researchers, 2–3 times by caregivers), 30–45 min/session. We will assess UE function using standardised tests (Quality of Upper Extremity Skills Test and Shriner’s Hospital Upper Extremity Evaluation), reaching kinematics, wrist-worn accelerometry, caregiver-rated ABILHAND-Kids questionnaire, and training-specific measures of movement control during RNT. Programme feasibility and acceptance will be assessed using device use metrics, child and caregiver exit questionnaires, training-specific measures of child engagement, and the Physical Activity Enjoyment Scale. All assessments will be conducted at pretest, following the control phase (midpoint), and after completion of the intervention phase (post-test).Ethics and disseminationThe study is approved by the Institutional Review Board of the University of Connecticut (# H22-0059). 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Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.</rights><rights>2023 Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. 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This study builds on our past work and will assess the effects of a 6-week researcher-caregiver codelivered, home-based ride-on-toy navigation training (RNT) programme in young children with UCP. We hypothesise that the RNT programme will be acceptable, feasible to implement, and lead to greater improvements in unimanual and bimanual function when combined with conventional therapy, compared with conventional therapy provided alone.Methods and analysis15 children with UCP between 3 and 8 years will be recruited. During the 6-week control phase, participants will receive treatement-as-usual alone. During the subsequent 6-week intervention phase, in addition to conventional therapy, RNT will be provided 4–5 times/week (2 times by researchers, 2–3 times by caregivers), 30–45 min/session. 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Results from this study will be disseminated through peer-reviewed manuscripts in scientific journals in the field, through national and international conferences, and through presentations to parent advocacy groups and other support organisations associated with CP.Trial registration numberNCT05559320.</abstract><cop>England</cop><pub>British Medical Journal Publishing Group</pub><pmid>37160396</pmid><doi>10.1136/bmjopen-2023-071742</doi><orcidid>https://orcid.org/0000-0003-4594-2547</orcidid><orcidid>https://orcid.org/0000-0002-9538-9228</orcidid><oa>free_for_read</oa></addata></record>
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subjects Accelerometry
Benchmarking
Caregivers
Cerebral palsy
Cerebral Palsy - therapy
Child
Child, Preschool
Children & youth
Clinical medicine
community child health
developmental neurology & neurodisability
Feedback
Humans
Intervention
Pediatrics
Rehabilitation
rehabilitation medicine
Reproductive Medicine
Upper Extremity
Wrist
title A protocol for a single-arm interventional study assessing the effects of a home-based joystick-operated ride-on-toy navigation training programme to improve affected upper extremity function and spontaneous use in children with unilateral cerebral palsy (UCP)
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