Home-Based Training With Feedback to Improve Outcomes in Adolescents and Young Adults With Cerebral Palsy..

Официальное название

The THRIVE-CP Trial - Targeted Home-Based Training With Real-Time Feedback to Improve Versatile Movement Behaviors and Enhance Outcomes in Adolescents and Young Adults With Cerebral Palsy: Protocol for a Randomized Controlled Trial.

Обзор

This clinical trial aims to determine whether extrinsic feedback through music enhances the effects of home-based motor training for adolescents and young adults with cerebral palsy (CP) and whether feedback improves adherence to the training program. The main questions it aims to answer are: * Does extrinsic feedback improve real-world movement more than home training alone? * Do participants receiving extrinsic feedback adhere more closely to their training program? To determine its effectiveness, the investigators will compare home-based training with and without real-time music feedback. Participants will: * Engage in a home-based motor training program for 12 weeks, tailored to their individual needs and goals. * Receive real-time music feedback during training or no feedback (control group). * Attend weekly virtual coaching sessions to discuss short-term goals and training progress. * Undergo movement assessments before training, at 12 weeks (T2) and 24 weeks (T3). * Wear movement sensors for 72 hours at T2 and T3 to track real-world movement behavior.

Вмешательства

• Поведенческое Music Motion Group
  Participants will engage in personalized, home-based motor training programs tailored to their individual goals. Each will wear a wireless Inertial Measurement Unit (IMU) on the targeted body part, which transmits movement data via Bluetooth to a tablet app. The training emphasizes task specificity and intensity, with five virtual check-ins to review progress and adjust training parameters. The intervention studied is extrinsic feedback; the app analyzes movement data and provides feedback thro
• Поведенческое Control
  Participants will follow personalized, home-based motor training programs designed like the Music motion group. They will wear a wireless Inertial Measurement Unit (IMU) on the targeted body part, transmitting movement data via Bluetooth to a tablet app. However, unlike the Music Motion Feedback group, participants in the Control group will not receive any extrinsic feedback during their training.

Первичные конечные точки

• Percentage change in daytime movement of the trained extremity (right or left arm or leg) as measured by 3-axis accelerometer and gyroscope data analyzed via deep-learning neural network [Срок оценки: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)]

Вторичные конечные точки (10)

• Number of daily logins to the tablet app [Срок оценки: The app stores the data during the intervention period and will be collected at 12 weeks (end of intervention period)]
• Daily session duration recorded in the tablet app [Срок оценки: The app stores the data during the intervention period and will be collectedThe app stores the data during the intervention period and will be collected at 12 weeks (end of intervention period)]
• Time spent moving the targeted extremity during training recorded in the tablet app [Срок оценки: The app stores the data during the intervention period and will be collected The app stores the data during the intervention period and will be collected at 12 weeks (end of intervention period)]
• Time spent within target movement intensity threshold recorded in the tablet app [Срок оценки: The app stores the data during the intervention period and will be collected The app stores the data during the intervention period and will be collected at 12 weeks (end of intervention period)]
• Action Research Arm Test (ARAT) total score - (Upper Extremity) [Срок оценки: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)]
• Maximum isometric arm strength - (Upper Extremity) [Срок оценки: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)]
• Maximum grip strength - (Upper Extremity) [Срок оценки: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)]
• Gross Motor Function Measure-66 (GMFM-66) total score - (Lower Extremity) [Срок оценки: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)]
• Maximum isometric leg strength - (Lower Extremity) [Срок оценки: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)]
• Distance walked during the Six-Minute Walk Test (6MWT) - (Lower Extremity) [Срок оценки: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)]

Критерии участия

Критерии включения

• Clinical diagnosis of cerebral palsy
• Sensorimotor deficits in at least one limb
• Demonstrated motivation to develop or regain motor skills, indicated by the expression of specific goals
• Ability to follow instructions independently or with caregiver support
• Ability to provide informed consent

Критерии исключения

• Diagnosis of dyskinetic cerebral palsy
• Presence of significant health risks that could interfere with participation
• Surgery or first Botox injection within one month before the trial or during the trial period

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• CP Youth Clinic, Copenhagen University Hospital - Rigshospitalet — Copenhagen

Идентификаторы

NCT: NCT06962618 · THRIVE-CP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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