Impact of a Personalized, High-Dose, Intensive Motor Rehabilitation Program, Integrating Advanced Technology for Adults With Central Neurological Conditions (INTeRAcT): Protocol for a Single-Blind Randomized Controlled Trial With a Clinical, Health Economic, and Process Evaluation.

内容摘要

Chronic stroke and spinal cord injury (SCI) lead to persistent motor impairments that reduce independence and quality of life. Although rehabilitation is essential to address these challenges, the amount of therapy provided during the chronic phase remains limited, while the long-term costs of care are substantial. The INTeRAcT (Intensive Rehabilitation Programme Integrating Advanced Technology) trial investigates a high-dose, intensive-targeted, and personalized rehabilitation program through an integrated clinical, health economic, and process evaluation. This single-blind randomized controlled trial will include 100 adults in the chronic phase after stroke or SCI. Participants will be randomized to either the INTeRAcT intervention group (n=50) or a control group receiving usual care (n=50). The intervention group will receive 90 hours of personalized motor rehabilitation over 3 weeks, including upper and lower limb therapy, with and without technology, cardiovascular fitness training, and self-management education. Both groups then resume usual care and are followed for 9 months. Clinical assessments are performed at baseline (T0), after 3 weeks (T1, postintervention), and after 9-months follow-up (T2) by a blinded assessor. The primary outcome is independence in daily life, assessed using the Functional Independence Measure for stroke and the Spinal Cord Independence Measure for SCI. Secondary outcomes include the EQ-5D-5L, Canadian Occupational Performance Measure, Goal Attainment Scaling, Fatigue Severity Scale, and stroke-specific measures such as the Action Research Arm Test, Fugl-Meyer Assessment, 6-Minute and 10-Meter Walk-Test, and the Stroke Self-Efficacy Questionnaire. Group differences in clinical change will be analyzed using multivariate linear models. Health economic data will be collected using diaries and questionnaires, capturing direct and indirect costs. Cost-effectiveness will be assessed through a trial-based cost-utility analysis over 9 months and a Markov model over a lifetime horizon. The process evaluation follows the UK Medical Research Council framework, using mixed methods with quantitative and qualitative data from diaries, interviews, and observations, analyzed descriptively and thematically. The funding of the project started in February 2023. Protocol version 5 (accepted March 15, 2024). Participant recruitment occurred between June 2023 and September 2024, with a total of 102 participants enrolled. Data collection ended in July 2025. Data analysis is ongoing. This protocol outlines a randomized controlled trial integrating clinical, health economic, and process evaluations to assess a high-dose, individualized rehabilitation program. The findings will provide evidence on effectiveness, cost-effectiveness, and implementation feasibility in chronic stroke and SCI, supporting the optimization of long-term neurorehabilitation care.