Clinical trial NCT05204225: Clinical Effectiveness of the ReHand App in Hand Rehabilitation After Stroke
Official title: ReHand. The First Tablet Solution for the Neurological Post-Stroke Rehabilitation of the Most Functional Body Segment, The Hand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Mobility Limitation
Neurologic Disorder
Motor Disorders
Hand Presentation
Lead sponsor: University of Seville
Sponsor class: OTHER
Collaborators: name: Fondazione Don Carlo Gnocchi Onlus
name: Centro de Referencia Estatal de Atención Al Daño Cerebral
First posted: 2022-01-24
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.).

Primary outcomes:
measure: Motor function of the upper limb using Fugl-Meyer Motor Assessment of the Upper Extremity (FMA-UE)
timeFrame: Change from Baseline Fugl-Meyer Motor Assessment of the Upper Extremity (FMA-UE) at 4 weeks.
Secondary outcomes:
measure: Dexterity assessed using the Nine Hole Peg Test
timeFrame: Change from Baseline Nine Hole Peg Test at 4 weeks
measure: Grip strength assessed using a hydraulic grip dynamometer
timeFrame: Change from Baseline Grip Strength at 4 weeks
measure: Pinch strength assessed using a hydraulic pinch dynamometer
timeFrame: Change from Baseline Pinch Strength at 4 weeks
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente, O.U. de Neurología de Rehabilitación
city: Madrid
country: Spain
facility: Centro de Referencia Estatal de Atención al Daño Cerebral Adquirido (CEADAC)
Study officials:
affiliation: University of Seville
name: Pablo Rodriguez
role: PRINCIPAL_INVESTIGATOR
References: