Virtual Reality Rehabilitation for Shoulder Pathologies

Официальное название

Personalized Rehabilitation System Using Gamification With Virtual Reality Technology: A Feasibility Study

Обзор

Most rehabilitation protocols require patients to train the affected limbs with high regularity, following repetitive cycles of exercises, in order to recover mobility and strength. Nonetheless, the repetitive nature of these exercises can demotivate patients leading to less intense and committed training, if not ending with a lack of compliance toward the prescribed exercises, ultimately leading to a suboptimal recovery. For this reason, several research groups are investigating solutions to help patients in this process, using robotic support or protocols assisted by virtual reality (VR). Most of these studies have shown benefits, notably in the field of post-stroke rehabilitation, however numerous types of physical therapies have not been investigated yet. Therefore, the main goal of this study will be to explore if the combination of modern motion-tracking and VR can provide significant functional outcomes for the treatment of the most common upper limb pathologies. The investigators created a set of exergames designed to lead the patients through a gamified version of part of physiotherapy (PT). This modified therapy is expected to offer several benefits to the treatment with respect to a purely conventional therapy: (i) improved patient's motivation and commitment to the exercises; (ii) constant evaluation of the patient's performance, thanks to the use of motion tracking; (iii) session-by-session tuning of exercises difficulty; (iv) clear progress traceability; (v) real-time alerts in case of problematic or compensatory movements; (vi) measurement and evaluation of new metrics of movements quality that were not possible in conventional therapy setups. To evaluate the feasibility of this project, the investigators would like to test the VR system on a short series of patients during four sessions.

Вмешательства

• Устройство Rehabilitation using virtual reality
  During the four physiotherapy (PT) sessions (60 min for each session), a set of exercises from the conventional PT is replaced by multiple short sessions of 30 minutes each, where the patient will be equipped by a set of motion trackers mounted on a belt and on a set of straps to be worn around both arms and both forearms. The patient will also hold a controller in each hand and wear a commercial VR headset on his head. Then, thanks to the headset, the patient will be able to experience a set of

Первичные конечные точки

• Simulator Sickness Questionnaire [Срок оценки: Day 1]

Вторичные конечные точки (3)

• A reduced version of the Post-experimental Intrinsic Motivation Inventory [Срок оценки: Day 1]
• A reduced version of the Avatar Embodiment Questionnaire [Срок оценки: Day 1]
• Patient satisfaction [Срок оценки: Day 1]

Критерии участия

Критерии включения

• Adult patients able to understand the content of the patient information / consent form and give consent to take part in the research project
• Glenohumeral instability surgical treated with traumatic initial instability in a < 20 years old athlete, recurrent instability with one or more of the following criteria: a failure of conservative treatment, locked dislocation, failed prior surgery, high risk for further recurrence (i.e. collision or competitive athletes), Critical glenoid bone-loss (>15-20%), bipolar bone-loss resulting in "off-track" lesion
• Partial or complete rotator cuff repair with an indication to postoperative rehabilitation depending on surgeon recommendation
• Idiopathic, primary, or secondary frozen shoulder

Критерии исключения

• Patients with a language barrier hindering questionnaires completion
• Patients unlikely to attend clinical follow-up (e.g. when living abroad)
• Legal incompetence
• Enrolment of the investigators, his/her family members, employees and other dependent persons
• Non-motivated patients
• Active infection
• Exclusion criteria related to glenohumeral instability: uncontrolled epilepsy, spontaneous unidirectional instability in a hyperlax patient, multidirectional instability, elher-Danlos syndrome
• Exclusion criteria related to rotator cuff tears: Additional procedure(s) (muscle transfer, patch,…)
• Exclusion criteria related to VR use: Patients with a predisposition to motion sickness, Patients suffering from epilepsy or having any serious mental illness (schyzophrenia, neurological problems, etc.), Patients with visual impairment , Patients will intellectual disability that prevent them to understand how to use the VR rehabilitation system, Patients with bilateral upper limb injuries, as one side is needed as healthy reference

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• La Tour hospital — Meyrin

Идентификаторы

NCT: NCT06963983 · 2022-00166

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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