Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 10, 2026
Date Accepted: Mar 16, 2026
Impact of a high-dose intensive-targeted motor rehabilitation programme integrating advanced technology for adults with central neurological conditions (INTeRAcT): protocol for a single-blind randomised controlled trial with a clinical, health economic and process evaluation
ABSTRACT
Background:
Chronic stroke and spinal cord injury 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.
Objective:
The INTeRAcT trial investigates a high-dose, intensive-targeted, and personalised rehabilitation programme through an integrated clinical, health economic, and process evaluation.
Methods:
This single-blind randomised controlled trial will include 100 adults in the chronic phase after stroke or spinal cord injury. Participants will be randomised 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 personalised motor rehabilitation over three 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 nine months. Clinical assessments are performed at baseline (T0), post-intervention (T1) and nine-month 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 spinal cord injury. 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 analysed 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 nine 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, analysed descriptively and thematically.
Results:
Protocol version 5 (15 March 2024). Participant recruitment occurred between July 2023 and September 2024, with a total of 101 participants enrolled.
Conclusions:
This protocol outlines a randomised controlled trial integrating clinical, health economic, and process evaluations to assess a high-dose, individualised rehabilitation programme. The findings will provide evidence on effectiveness, cost-effectiveness, and implementation feasibility in chronic stroke and spinal cord injury, supporting the optimisation of long-term neurorehabilitation care. Clinical Trial: clinicaltrials.gov NCT05970367 Registered: 31 July 2023 https://clinicaltrials.gov/study/NCT05970367
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