Instructions for use ReHand for professionals

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Instructions for use ReHand 2.0.0

Revision Level: version 1

Revision Date: December 1st 2021

Welcome to ReHand!

Before starting with the Instructions for Use, we welcome you to ReHand. ReHand is the first evidence-based digital Tablet solution for the rehabilitation of wrist-hand-finger segment affectation. ReHand offers a rehabilitation service customized to both the physiological characteristics of the patient, their condition and time of recovery, as well as for the healthcare professional who prescribes and monitors it.

These instructions are intended to help the healthcare professional to start the prescription, treatment and monitoring with ReHand. Likewise, the app presents explanatory videos at the beginning of each exercise and audio instructions, so we recommend using the app with the volume of the Tablet device turned on and watching the videos before performing each exercise. In case your doubts are not solved with this document, please contact us at [email protected].

WARNING: Read these instructions carefully before using ReHand. To prevent its misuse, it is necessary to obtain a prescription from a healthcare professional so the exercise program can be properly adapted to the patient’s condition and monitored.

1. The concept of ReHand

ReHand is composed of two systems: REHAND APP is the tool used by the patient and REHAND DASHBOARD is the one used by the healthcare professional.

REHAND APP is a rehabilitation app for the wrist, hand and finger segment that includes a battery of exercises that address the recovery of different functionalities of this segment, through a series of routes on the touchscreen of Tablet devices. These routes through the screen are guided by circles, each one with a colour depending on the finger, that makes contact with the screen. Prior to each exercise, there is a double adjustment that allows the exercise to be adapted to the size of the hand and to the patient´s limitation.

WARNING: We advise you to tell your patient that if he/she feels pain or excessive fatigue while performing the exercises or after the use of ReHand, stop the exercise and consult you.

Likewise, these exercises have a gamification system that makes the difficulty of the exercises increase as the patient obtains better scores when performing the exercises, increasing the speed of the exercises and decreasing the size of the circles. The exercises adapted to the limitation of each patient have been designed in accordance with current scientific evidence regarding the improvement of the functional limitation of the hand.

ReHand App also has a page of questionnaires and scales, where the patient periodically receives a series of questionnaires and scales relating to parameters such as functional ability or pain. In addition, ReHand App has a progress page on which statistics and graphs of patient adherence/performance are displayed and messages are given based on these, allowing patient motivation and generating continuous feedback on their evolution. At the same time, these statistics are sent to the therapist, in order to periodically monitor his/her patient.

REHAND DASHBOARD is a management panel that makes ReHand available to organize patients according to the healthcare professionals who have prescribed them, so that they can follow them up. It has a therapeutic exercise program generator where the healthcare professional can configure the program for their patients according to their condition. In addition, it allows the healthcare professional to monitor the patient.

2. Intended Use

ReHand´s indication is hand-wrist-finger conditions. The scope of such indication includes:

1.- WRIST AND CARPAL FRACTURES.

2.- METACARPAL AND PHALANGES BONES FRACTURES.

3.- NERVE PATHOLOGY.

4.- NON-SURGICAL OPERATED SOFT TISSUE PATHOLOGY.

5.- SOFT TISSUE SURGERY.

6.- ELBOW PATHOLOGY.

7.- DISLOCATIONS, CONTUSIONS, SPRAINS IN THE WRIST, HAND AND FINGERS.

8.- POST-SURGICAL REHABILITATION.

9.- NEUROVEGETATIVE PATHOLOGY.

10.- RHEUMATIC PATHOLOGY.

11.- NEUROLOGICAL PATHOLOGY.

According to the results of the clinical trials conducted and the existing scientific evidence, its use would preliminarily lead to an early improvement in clinical variables such as functional ability, dexterity or strength.

3. Contraindications

— Any circumstance in which the exercise implies the interruption of the tissue healing process. Symptoms such as increased pain, erroneous movements, swelling or flushing, will be a determining factor in the interruption of the therapy.

— Presence of severe muscular or joint pain during the execution of your program or that is maintained beyond 24 hours after its execution.

— Acute infectious and inflammatory processes in the wrist-hand-finger segment undergoing therapy.

— Haematomas or other signs of traumatism appearance in the wrist-hand-fingers segment undergoing therapy.

— Presence of coagulopathies or circulatory disorders that have not been controlled by medical treatment.

— Presence of a tumor or history of unexplained weight loss, excessive night sweating, unexplained fatigue and/or pain that does not vary in any position, as long as it has not been controlled with medical treatment.

— Physical disability that compromises patient safety.

— Serious psychiatric disorders.

Do not use the ReHand digital tool in the cases set out above unless the patient has undergone a prior medical examination which concludes that, given the existence of any of them, the use of ReHand is the appropriate approach.

The therapist must guide the patient in the performance of the exercises in order to adapt the ReHand therapy to the range of movement, tolerance and speed in accordance with the state of recovery.

WARNING: Supervised therapy (with the addition of ReHand practice in consultation or at home) may be necessary in the following cases, according to the clinical judgement of the prescribing health professional:

— Moderate median nerve compression

— Carpal Tunnel Syndrome

— Moderate radial nerve compression

— Neuropathy

— Complex regional pain syndrome (abnormal pain, stiffness, vasomotor symptoms)

— Ulnar nerve compression

— Carpal instability/subluxation

— Moderate adhesion formation or tendon scar

— Moderate tendon rupture

— Moderate tendinopathy

— Moderate trigger finger

— Age over 65

WARNING: Use ReHand responsibly. Use it only when you understand and master the program´s terminology. The information collected by ReHand is merely indicative and cannot be used for therapeutic or diagnostic purposes.

ReHand consists of three systems: a prescription system, which allows the healthcare professional to prescribe therapeutic exercise programs adapted to the patient’s condition and time of recovery; a treatment system, which allows the patient to carry out his or her exercise program by touching and performing routes on the Tablet screen; and a monitoring system, which allows the healthcare professional to monitor his or her patients. The three systems are described below:

4. Prescription

4.1. Access to ReHand Dashboard

When starting a treatment with a patient, it is necessary to first make the patient’s prescription to ReHand. To do this, the Dashboard management panel can be accessed from a smartphone, tablet or computer through the following link: https://rehand.net/dashboard.

4.2. Program generation

The patient’s access to his/her therapeutic exercise program is done through a code, which is generated after the prescription and selection of programs and exercises.

4.3. Code submission

The Healthcare Professional can email the code to the patient by clicking the ‘Send access to my patient’ button.

5. Treatment: Exercise Program

5.1. Initial Instructions

Once the patient is registered in the application, the following ‘Program’ page appears:

A pop-up will then automatically appear with a general video explaining how the application works, which can be found at the following link: https://youtu.be/aZiFc-81-5s.

This video, which will no longer appear automatically, can be watched again in the ‘Account’ section along with the other videos explaining the exercises.


GENERALS WARNINGS:

— Always follow the instructions given by ReHand. The patient must answer honestly the questionnaires received to improve his/her recovery.

— Never share your ReHand account with others.

— The patient must update the application when a new version is released. Updates may contain security enhancements.

— Do not use ReHand on devices lower than 6.0.1 on Android or 11 on iOS as it may affect the operation and performance of the application.

— ReHand must be used on a tablet device with a screen larger than 7” in order not to limit the functionalities of the application.

— Any serious incident related to ReHand should be reported to us by email to [email protected] and to the competent authority of the Member State where you are established.


Afterwards, a pop-up appears with a warning of a new initial scale that can be found in the ‘Scales’ section.

TUTORIAL ICON

An information icon is also available on the top left of the ‘Program’ menu. When you click on it, the initial instructions are shown. They will be displayed as you click on the ‘next arrow’ button.

HAND SELECTION

At the top of the ‘Program’ page there is a button to select the hand you wish to view the programmed exercises for. If no exercise card appears on the screen, this means there is no exercise configured for that selected hand.

EXERCISE CARD

Each exercise is represented by a card where the type of exercise and hand to be treated is reflected in an image. The name of the exercise appears immediately below, followed by the finger/area.

DAILY REPETITIONS

To keep track of the repetitions made during the day, the crosses represent the number of daily repetitions to be made. As each repetition is performed, each cross changes to a green tick.

LEVEL

Each blue circle represents the level of the exercise you are in. Therefore, as exercises with a good score are performed, the level of the exercise increases. On the other hand, if exercises with a low score are performed, the level decreases.

SPEED BAR

To level up in the exercises, it is necessary to achieve a score greater than 90 for each repetition as the speed bar increases.

Finally, we recommend to activate the sound while using the application. If the patient has any doubts or problems, we recommend to consult the ‘FAQs (Frequently Asked Questions) section by clicking on the ‘Account’ button or to write to us at [email protected].

5.2. Exercises

Furthermore, before carrying out the exercise, the following instructions are given, complementing the text with audio messages for execution.

A. START OF ADJUSTEMENT

When clicking on an exercise card, the patient accesses the exercise and is given instructions on how to adjust the position. Before starting the adjustment, the patient is also given the opportunity to watch a video explaining the procedure.

B. EXPLANATORY VIDEO

The correct way to perform the adjustment and the exercise is described in the explanatory video.

C. POSITION ADJUSTMENT I

During the first adjustment, a gif explaining the patient how to adjust the position is displayed.

D. POSITION ADJUSTMENT II

In this first step, a position adjustment is performed. The patient has to place a certain hand-finger segment on the tablet screen so that this position is recorded.

E. MOVEMENT ADJUSTEMENT GIF

During the second adjustment, a gif explaining the patient how to make the movement adjustment is displayed.

F. MOVEMENT ADJUSTMENT

In this second step a movement adjustment is made. The patient must perform three times the movement of the exercise in a non-painful parameter. This non-pain range, optimal for the execution of the exercise, is recorded, and will be used later for the execution of the exercise.

G. EXERCISE EXECUTION

The exercise is carried out by moving or tapping on the screen, in the range configured by the movement adjustment. The exercise is timed and a performance score is reported based on how well the exercise was performed.

H. EXERCISE RESULT

At the end of the exercise, the patient is informed of the score obtained in the exercise.

5.3. Progress

Clicking on the ‘Progress’ icon shows the page of the work carried out, where all the exercises performed are represented in a progress chart over time and each colour block corresponds to one of those exercises. Clicking on the blocks displays the name of each exercise, the hand related to it, the number of repetitions performed, and a dashed line at the top, representing the number of daily repetitions expected throughout the treatment.

The percentage of adherence is calculated from the number of expected and performed repetitions, and shown next to the feedback messages of the application itself.

6. Monitoring

Finally, while treated with the ReHand App, the patient is monitored by the healthcare professional through the Dashboard, where graphs, questionnaires and the patient progress is displayed.

Patient follow-up can also be monitored through the generation of reports, where this data is summarized. These reports are generated from the Dashboard by the healthcare professional.

7. Manufacturer´s data

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