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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 |
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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). 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.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2023-071742</identifier><identifier>PMID: 37160396</identifier><language>eng</language><publisher>England: British Medical Journal Publishing Group</publisher><subject>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</subject><ispartof>BMJ open, 2023-05, Vol.13 (5), p.e071742-e071742</ispartof><rights>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.</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. No commercial re-use. See rights and permissions. Published by BMJ. 2023</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b540t-7787873e5f4dacc93534a16f6c55f9cf3394e3c961e52db314d12b40f2f53cc3</citedby><cites>FETCH-LOGICAL-b540t-7787873e5f4dacc93534a16f6c55f9cf3394e3c961e52db314d12b40f2f53cc3</cites><orcidid>0000-0003-4594-2547 ; 0000-0002-9538-9228</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/2811285002/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/2811285002?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,3194,25753,27924,27925,37012,37013,44590,53791,53793,55341,55350,75126,77596,77597,77660,77686</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37160396$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shahane, Vaishnavi</creatorcontrib><creatorcontrib>Kumavor, Patrick</creatorcontrib><creatorcontrib>Morgan, Kristin</creatorcontrib><creatorcontrib>Friel, Kathleen M</creatorcontrib><creatorcontrib>Srinivasan, Sudha Madhav</creatorcontrib><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)</title><title>BMJ open</title><addtitle>BMJ Open</addtitle><addtitle>BMJ Open</addtitle><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. 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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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Kumavor, Patrick ; Morgan, Kristin ; Friel, Kathleen M ; Srinivasan, Sudha Madhav</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b540t-7787873e5f4dacc93534a16f6c55f9cf3394e3c961e52db314d12b40f2f53cc3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Accelerometry</topic><topic>Benchmarking</topic><topic>Caregivers</topic><topic>Cerebral palsy</topic><topic>Cerebral Palsy - therapy</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Children & youth</topic><topic>Clinical medicine</topic><topic>community child health</topic><topic>developmental neurology & neurodisability</topic><topic>Feedback</topic><topic>Humans</topic><topic>Intervention</topic><topic>Pediatrics</topic><topic>Rehabilitation</topic><topic>rehabilitation medicine</topic><topic>Reproductive Medicine</topic><topic>Upper Extremity</topic><topic>Wrist</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shahane, Vaishnavi</creatorcontrib><creatorcontrib>Kumavor, Patrick</creatorcontrib><creatorcontrib>Morgan, Kristin</creatorcontrib><creatorcontrib>Friel, Kathleen M</creatorcontrib><creatorcontrib>Srinivasan, Sudha Madhav</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>ProQuest Nursing & Allied Health Database</collection><collection>ProQuest Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>AUTh Library subscriptions: ProQuest Central</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>Psychology Database (ProQuest)</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content (ProQuest)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>BMJ open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shahane, Vaishnavi</au><au>Kumavor, Patrick</au><au>Morgan, Kristin</au><au>Friel, Kathleen M</au><au>Srinivasan, Sudha Madhav</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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)</atitle><jtitle>BMJ open</jtitle><stitle>BMJ Open</stitle><addtitle>BMJ Open</addtitle><date>2023-05-09</date><risdate>2023</risdate><volume>13</volume><issue>5</issue><spage>e071742</spage><epage>e071742</epage><pages>e071742-e071742</pages><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>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.</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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