Skip to main content
Clinical Trials/NCT05204225
NCT05204225
Completed
N/A

ReHand. The First Tablet Solution for the Neurological Post-Stroke Rehabilitation of the Most Functional Body Segment, The Hand

University of Seville2 sites in 2 countries33 target enrollmentJanuary 26, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
University of Seville
Enrollment
33
Locations
2
Primary Endpoint
Motor function of the upper limb using Fugl-Meyer Motor Assessment of the Upper Extremity (FMA-UE)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 26, 2022
End Date
March 26, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pablo Rodríguez

Principal Investigator, PhD Candidate

University of Seville

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.).

Outcomes

Primary Outcomes

Motor function of the upper limb using Fugl-Meyer Motor Assessment of the Upper Extremity (FMA-UE)

Time Frame: Change from Baseline Fugl-Meyer Motor Assessment of the Upper Extremity (FMA-UE) at 4 weeks.

A specific scale for the assessment of sensorimotor function of the upper limb after stroke. It includes 33 items, which are rated from 0 to 2 (0 = cannot perform it, 1 = partially perform it, 2 = maximum performance). Its overall score range from 0 to 66. Higher values correspond to greater motor ability.

Secondary Outcomes

  • Dexterity assessed using the Nine Hole Peg Test(Change from Baseline Nine Hole Peg Test at 4 weeks)
  • Grip strength assessed using a hydraulic grip dynamometer(Change from Baseline Grip Strength at 4 weeks)
  • Pinch strength assessed using a hydraulic pinch dynamometer(Change from Baseline Pinch Strength at 4 weeks)

Study Sites (2)

Loading locations...

Similar Trials