Clinical Effectiveness of the ReHand App in Hand Rehabilitation After Stroke

University of Seville

Status: Completed

Conditions: Stroke; Motor Disorders; Mobility Limitation; Neurologic Disorder; Hand Presentation

Treatments: Other: Conventional Treatment; Other: Tablet Application

Study type: Interventional

Funder types: Other

Identifiers

NCT05204225

825003

Details and patient eligibility

About

Stroke is the third leading cause of disability worldwide, with the hand being one of the segments whose affectation generates the greatest limitation in functional ability and quality of life. Neurorehabilitation is the most effective therapy as long as it is implemented both in the early (post-hospital stages) and in an intensive approach. However, the resources of healthcare systems are not enough to address the neurorehabilitation needs of patients with hand affectation after stroke. Thus, current scientific literature advocates transferring such rehabilitation to the patient's home through therapeutic exercise programs - whose clinical and economic effectiveness has already been demonstrated - as a way of reducing the consumption of resources. In order to achieve this, telerehabilitation is suggested as one of the most viable formats. However, current telerehabilitation systems such as video games and virtual reality do not provide a fully viable solution, mainly due to the lack of scalability and penetration of the technology, and the lack of a hand specific approach, whose importance is crucial in the recovery of function and autonomy in Activities of Daily Living (ADL). Different articles and reviews confirm the potential of tablet devices to solve these issues given their scalability and the multisensory feedback provided, making possible a more productive and intensive motor training and sensory stimulation in order to optimize cortical reorganization and neuroplasticity after a stroke. Both health professionals and patients have expressed the need for a specific Tablet application for neurorehabilitation of the hand after stroke, that follows the precepts established by the evidence. However, the lack of specific applications for this approach means that existing apps are used as an adaptation. Therefore, we propose the development and preliminary validation of ReHand, the first Tablet application developed according to the needs of healthcare professionals and patients, and the precepts of the most updated scientific literature, which allows the patient to perform an active therapy adapted to its hand limitations, and the healthcare professional to monitor their patient's home performance.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Older than 18 years.
• From 1 week to 6 months after stroke
• Ischemic or hemorrhagic stroke confirmation by computed tomography or magnetic resonance imaging.
• No previous impairments of the upper limb with the stroke affectation.
• Score above 20 on the Minimental State Examination test.
• Alertness and medical stability declared by the responsible neurologist and with ability to follow simple verbal commands
• Ability to move fingers, even partially.

Exclusion criteria

• Acute traumatic or orthopedic involvement of the limb in concern.
• Unstable medical condition (life expectancy less than 3 months, uncontrolled hypertension, unstable angina, recent myocardial infarction, etc.).
• Any medical condition that may confound interpretation of results or put the patient at risk (e.g. amputated finger, psychiatric illness, etc.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

33 participants in 2 patient groups

Tablet Application

Experimental group

Description:

An exercise program based on the current evidence will be provided through a tablet application (ReHand) along with the face-to-face conventional approach of each recruitment centres. A follow-up of the use of the application will be carried out. The treatment protocol will last 4 weeks, including daily exercise sessions of 30-60 minutes of duration at home though the application tablet.

Treatment:

Other: Tablet Application

Conventional Treatment

Active Comparator group

Description:

Participants included in this group will receive the conventional treatment protocol usually prescribed on each recruitment centres. Participants will be asked to perform an exercise program on paper during 4 weeks at home, along with face-to-face sessions.

Treatment:

Other: Conventional Treatment