The Mechatronic Remote Physiotherapy System (MRPS) in Remote Stroke Rehabilitation

Официальное название

The Mechatronic Remote Physiotherapy System (MRPS) in Remote Stroke Rehabilitation: A Pilot Controlled Trial for 'Early Supported Discharge'

Обзор

The aim of this pilot trial is to examine and compare the safety and feasibility of enhanced Early Supported Discharge (ESD) through the Mechatronic Remote Physiotherapy System (MRPS) and traditional ESD after stroke. The main questions this trial aims to answer are: * Is enhanced ESD via the MRPS safe, feasible and significantly different compared to traditional ESD when administered to patients after stroke? * Do patients interact with and are they satisfied with the MRPS? * Is enhanced ESD cost-effective compared to traditional ESD? * Are there any adverse effects of the MRPS and what are the areas for further improvement? Participants in the experimental group will receive enhanced ESD through the MRPS. The intervention will be given for approximately 6-8 weeks in total. Frequency will be determined by how often the participants' use the MRPS themselves. Frequency of use and level of completion of each session will be monitored. Enhanced ESD therapy sessions will be designed to reflect traditional ESD sessions. Participants in the control group will receive traditional ESD. The intervention will be given for approximately 6-8 weeks in total with a frequency of 1-3 therapy visits per week (as per traditional ESD). Therapy sessions will be designed by therapists delivering the ESD service.

Подробное описание

The Mechatronic Remote Physiotherapy System (MRPS) is an Online Rehabilitation Platform for neurology patients. The platform has been designed to provide supervised and monitored remote rehabilitation therapy, initially focusing on patients who have suffered a stroke. The system comprises of a patent pending mirror therapy strengthening device, which is a neural therapy device using mirror therapy and exercise apparatus for upper limb rehabilitation. The platform also permits the addition of modules beneficial to the patients' recovery. The use of a sensory substitution balance apparatus and motion capturing sensors are also being developed to allow for lower limb rehabilitation.

Participants will be randomly allocated to an experimental (n=7) or control group (n=7) using a block stratified randomization process. Block randomization will be stratified for age, gender and degree of disability (computer-generated random numbers) with allocation concealment.

Вмешательства

• Устройство Mechatronic Remote Physiotherapy System (MRPS)
  The MRPS is an Online Rehabilitation Platform for neurology patients. The platform has been designed to provide supervised and monitored remote rehabilitation therapy, initially focusing on patients who have suffered a stroke. The system comprises of a patent pending mirror therapy strengthening device, which is a neural therapy device using mirror therapy and exercise apparatus for upper limb rehabilitation. The platform also permits the addition of modules beneficial to the patients' recovery.
• Другое Early Supported Discharge
  ESD is a multidisciplinary service providing medically stable patients continued therapy and healthcare in the community.

Первичные конечные точки

• Protocol Adherence/Compliance Rate. [Срок оценки: through study completion, an average of 1 year]

Вторичные конечные точки (2)

• Berg Balance Scale (BBS). [Срок оценки: through study completion, an average of 1 year]
• Fugl Meyer Assessment (FMA). [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• A clinical diagnosis of stroke;
• Completed inpatient rehabilitation;
• A level of ability that would allow them to participate safely (as determined by ESD team);
• Cognitive ability to consent and take part;
• Technological ability and resources to allow them to access MRPS platform;
• A proficiency in the English Language.

Критерии исключения

• Involvement in other studies or rehabilitation programmes;
• A level of disability that would prevent them from participating safely (as determined by ESD team);
• Low level technological literacy or resources (e.g. Wi-Fi) which would prevent access to MRPS platform;
• Have uncontrolled medical condition or another serious medication condition in addition to stroke;
• Unable to understand or follow directions.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06964789 · ATU Sligo

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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