Effects of a remote-handling-concept-based task-oriented arm training (ReHab-TOAT) on arm-hand skill performance in chronic stroke: a study protocol for a two-armed randomized controlled trial.

BACKGROUND

Improving arm-hand skill performance is a major therapeutic target in stroke rehabilitation and needs intensive and varied training. However, guided treatment time is limited. Technology can assist in the training of patients, offering a higher intensity and more variety in content. A new task-oriented arm training approach was developed, using a 'Remote Handling concept based' device to provide haptic feedback during the performance of daily living activities (ReHab-TOAT). This study aims to investigate the effects of ReHab-TOAT on patients' arm-hand function and arm-hand skill performance, quality of life of both patients in the chronic phase after stroke and their caregivers and the patients' perception regarding the usability of the intervention.

METHODS

A randomized clinical trial was designed. Adult chronic stroke patients suffering from hemiparesis and arm-hand problems, with an Utrechtse Arm-hand Test score of 1-3, will be invited to participate. Participants in the experimental group receive ReHab-TOAT additional to care as usual. ReHab-TOAT contains task-oriented arm training for stroke patients in combination with haptic feedback, generated by a remote handling device. They will train for 4 weeks, 3× per week, 1.5h per day. Participants in the control group will receive no additional therapy apart from care as usual. The Fugl-Meyer Assessment (FMA), measuring participants' motor performance of the affected arm, is used as the primary outcome measure. Secondary outcome measures are arm-hand capacity of the patient (ARAT), perceived arm-hand skill performance (MAL), actual arm-hand skill performance (accelerometry), patients' quality of life (EuoQol-5D) and caregivers' quality of life (CarerQoL). Participants' perception regarding the usability of the intervention, including both the developed approach and technology used, will be evaluated by the System Usability Scale and a questionnaire on the user experience of technology. Measurements will be performed at 1, 2, 3 and 4 weeks pre-intervention (baseline); immediately post-intervention; and 3, 6 and 9 months post-intervention. Statistical analysis includes linear mixed model analysis.

DISCUSSION

This study is designed to investigate the evidence regarding the effects of ReHab-TOAT on patients' performance at different levels of the International Classification of Functioning, disability and health (ICF) model, i.e. a framework measuring functioning and disability in relation to a health condition, and to provide insights on a successful development and research process regarding technology-assisted training in co-creation.

TRIAL REGISTRATION

Netherlands Trial Register NL9541. Registered on June 22, 2021.