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

Introduction

Chronic stroke and spinal cord injury are both associated with persistent motor impairments, resulting in reduced independence in daily life and lower 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 cost of care is substantial. Here, we describe the INTeRAcT protocol: a randomised controlled trial with a clinical, health economic and process evaluation, designed to assess the effectiveness of a high-dose, intensive-targeted and personalised rehabilitation programme.

Methods and analysis

In this single-blind randomised controlled trial, we aim to recruit 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 advanced technology, cardiovascular fitness training, and self-management education. After the intervention, both groups return to usual care and are followed up for nine months. Clinical outcomes will be assessed by a blinded assessor at baseline (T0), post-intervention (T1), and at nine-month follow-up (T2), with additional data collected throughout for the health economic and process evaluations.

The primary clinical outcome is independence in daily life, assessed using the Functional Independence Measure for participants with stroke, and the Spinal Cord Independence Measure for those with spinal cord injury. Secondary clinical outcomes include the EuroQol 5D-5L, Canadian Occupational Performance Measure, Goal Attainment Scaling, and the Fatigue Severity Scale. Additional stroke-specific secondary outcomes are the Action Research Arm Test, Fugl-Meyer Assessment, Functional Ambulation Categories, the 6 Minute Walk Test, 10 Meter Walk Test, and the Stroke Self-Efficacy Questionnaire. A multivariate linear model will be used to compare clinical changes between the two groups. Health economic data will be collected using diaries and questionnaires, capturing direct and indirect costs such as healthcare use, medication, transport, productivity loss, and informal care. Effects will be measured via the EQ-5D-5L and expressed in Quality-Adjusted Life Years. Cost-effectiveness will be assessed through a trial-based cost-utility analysis over a nine-month horizon and a Markov model over a lifetime horizon, complemented by scenario analyses and a budget-impact analysis.

The process evaluation, guided by the UK Medical Research Council framework, adopts a mixed-methods approach combining quantitative and qualitative data from structured diaries, semi-structured interviews, and observations. Quantitative data will be presented descriptively, while qualitative data will be examined using both content and thematic analysis.

Ethics and dissemination

Ethical approval was obtained from the central and local ethics committees on 10 July 2023. The currently approved protocol is version 5, dated 15 March 2024. All participants provide written informed consent prior to enrolment. Study findings will be disseminated through peer-reviewed journals and presentations at national and international conferences, as well as at various stakeholder events.

Trial registration number

NCT05970367 (31 July 2023)

ARTICLE SUMMARY