Bootle Blast: Pilot Randomized Controlled Trial

MI-összefoglaló

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The trial is looking for children and youth aged 6 to 17 with hemiplegic cerebral palsy (one side of the body affected). They will play a movement-tracking video game at home to practise arm and hand skills.

Életkor

6 to 17 years

Nem

All sexes

A betegség stádiuma

Hemiplegic cerebral palsy, MACS levels I (handles objects easily) to III (handles objects with difficulty).

Korábbi kezelés

No upper limb surgery or botulin toxin injections in the past 4 months. No constraint therapy or casting in the previous 3 months.

A részvétel fő kizáró okai

• Current or planned treatments that affect arm function during the study
• Uncontrolled epilepsy that video game play may trigger
• A medical condition that makes the game's physical activity unsafe
• Vision problems that interfere with playing the game
• Not able to communicate in English, travel to Holland Bloorview, Grandview or CHEO for 3 visits, or have a large screen with a 3m x 3m play space and some internet access

A regiszter feltételei, szó szerint

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

• 6 és 17 év között vagy?IgenNem

Mit akar kideríteni a vizsgálat

One in 500 Canadians has cerebral palsy (CP), a lifelong condition affecting movement and function. Physical and occupational therapies greatly benefit children with CP but can be costly and difficult to access. Children, parents, and clinicians are interested in using movement-tracking video games for home-based hand/arm therapy. Yet, the technologies and evidence to support this approach are limited. We partnered with key stakeholders and an interdisciplinary team to co-create Bootle Blast. Bootle Blast tracks skeletal movements and interactions with real-life objects, engaging children in individualized play experiences rich in feedback, task specificity, and opportunities for goal-directed motor practice linked to meaningful activities.

A vizsgálat 2 csoportja

• Bootle Blast Play Phase (0 - 12 weeks) followed by Standard Care (12 - 24 weeks)A vizsgált kezelés

  Participants receive the Bootle Blast home-based intervention immediately after baseline in-person clinic assessment at 0 weeks. Families complete 12 weeks of home-based play targeting a prescribed practice dose (15-20 minutes/day, 3-4 days/week), alongside ongoing standard care activities. Participants may also be randomized to receive weekly monitoring coach calls providing motivational and technical support. Participants complete in-person clinical assessments again at 12 and 24 weeks, and provide repeated COPM-goal videos, PRIME engagement data, and system-logged play data during the intervention period. After the 12-week assessment, they transition to standard care without Bootle Blast for weeks 12-24.

  Kezelés: Bootle Blast Intervention és Standard Care (Comparator)

• Waitlist Comparison - Standard Care (0-12 weeks) followed by Bootle Blast Play Phase (12-24 weeks)Egyéb csoport

  Participants continue with their usual standard care for the first 12 weeks after baseline assessment. During this period, they do not receive Bootle Blast but complete the same assessment schedule and repeated measures as the experimental group. After the 12-week assessment, they receive the Bootle Blast intervention following the same calibration and training procedure, with randomized monitoring coach support. They then complete the 12-week Bootle Blast period from weeks 12 to 24, along with follow-up assessments and repeated measurements. This group is likely representative of how Bootle Blast would be used in practice (complement or supplement to standard care).

  Kezelés: Bootle Blast Intervention és Standard Care (Comparator)