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Clinical Effectiveness of the ReHand App in Hand Rehabilitation After Stroke

Primary Purpose

Stroke, Mobility Limitation, Neurologic Disorder

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Tablet Application
Conventional Treatment
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.).

Sites / Locations

  • Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente, O.U. de Neurología de Rehabilitación
  • Centro de Referencia Estatal de Atención al Daño Cerebral Adquirido (CEADAC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tablet Application

Conventional Treatment

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Dexterity assessed using the Nine Hole Peg Test
Plastic instrument with a shallow round dish to contain pegs and nine holes on the opposite side. It consist of measuring the time spent to place and remove all the pegs from the holes.
Grip strength assessed using a hydraulic grip dynamometer
The Maximum power of the hand muscles used to firmly grasp an object by wrapping the fingers around it, pressing it against the palm, and using the thumb to apply counter-pressure, using a Hydraulic grip dynamometer
Pinch strength assessed using a hydraulic pinch dynamometer
The maximun power of the pinch muscles, pressing the tip thumb against the tip index finger, using an Hydraulic pinch dynamometer.

Full Information

First Posted
January 10, 2022
Last Updated
April 5, 2022
Sponsor
University of Seville
Collaborators
Fondazione Don Carlo Gnocchi Onlus, Centro de Referencia Estatal de Atención Al Daño Cerebral
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1. Study Identification

Unique Protocol Identification Number
NCT05204225
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 26, 2022 (Actual)
Primary Completion Date
February 26, 2022 (Actual)
Study Completion Date
March 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville
Collaborators
Fondazione Don Carlo Gnocchi Onlus, Centro de Referencia Estatal de Atención Al Daño Cerebral

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Mobility Limitation, Neurologic Disorder, Motor Disorders, Hand Presentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tablet Application
Arm Type
Experimental
Arm 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.
Arm Title
Conventional Treatment
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Tablet Application
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Motor function of the upper limb using Fugl-Meyer Motor Assessment of the Upper Extremity (FMA-UE)
Description
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.
Time Frame
Change from Baseline Fugl-Meyer Motor Assessment of the Upper Extremity (FMA-UE) at 4 weeks.
Secondary Outcome Measure Information:
Title
Dexterity assessed using the Nine Hole Peg Test
Description
Plastic instrument with a shallow round dish to contain pegs and nine holes on the opposite side. It consist of measuring the time spent to place and remove all the pegs from the holes.
Time Frame
Change from Baseline Nine Hole Peg Test at 4 weeks
Title
Grip strength assessed using a hydraulic grip dynamometer
Description
The Maximum power of the hand muscles used to firmly grasp an object by wrapping the fingers around it, pressing it against the palm, and using the thumb to apply counter-pressure, using a Hydraulic grip dynamometer
Time Frame
Change from Baseline Grip Strength at 4 weeks
Title
Pinch strength assessed using a hydraulic pinch dynamometer
Description
The maximun power of the pinch muscles, pressing the tip thumb against the tip index finger, using an Hydraulic pinch dynamometer.
Time Frame
Change from Baseline Pinch Strength at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Rodriguez
Organizational Affiliation
University of Seville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente, O.U. de Neurología de Rehabilitación
City
Milano
Country
Italy
Facility Name
Centro de Referencia Estatal de Atención al Daño Cerebral Adquirido (CEADAC)
City
Madrid
ZIP/Postal Code
28034
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Effectiveness of the ReHand App in Hand Rehabilitation After Stroke

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