Clinical Effectiveness of the ReHand App in Hand Rehabilitation After Stroke

NCT05204225 | Completed DMC

• 1 other identifier: 825003
• Study Type: interventional
• Target: 33
• Locations: 2 countries
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (3)

• 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 Arms (2)

Tablet Application

EXPERIMENTAL

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.

Other: Tablet Application

Conventional Treatment

ACTIVE COMPARATOR

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.

Other: Conventional Treatment

Interventions

Tablet Application OTHER

Participants will receive a tablet app (ReHand) along with face-to-face physiotherapy sessions. The ReHand app includes an exercise program based on current scientific evidence for improving funcional ability and dexterity of the hand with neurological affectation. Those exercises are performed making controlled taps and movements while touching the touchscreen and guided by feedbacks. Also, ReHand app includes a prescription and monitoring web-based system for professionals. Along with this intervention, face-to-face physiotherapy sessions will be performed their respective centres.

Tablet Application

Conventional Treatment OTHER

Participants of this group will receive a home exercise program on paper and face-to-face physiotherapy sessions. This intervention is the conventional approach usually delivered in their respective centres. Those exercises were specifically developed for the rehabilitation of the hand with neurological affectation.

Conventional Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• University of Seville: lead
• Fondazione Don Carlo Gnocchi Onlus: collaborator
• Centro de Referencia Estatal de Atención Al Daño Cerebral: collaborator

Study Sites (2)

Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente, O.U. de Neurología de Rehabilitación

Milan, Italy

Location

Centro de Referencia Estatal de Atención al Daño Cerebral Adquirido (CEADAC)

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Stroke; Mobility Limitation; Nervous System Diseases; Motor Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Pablo Rodriguez

  University of Seville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD Candidate

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: January 26, 2022
• Primary Completion: February 26, 2022
• Study Completion: March 26, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); ES (1)