Implementation of a Pilot Telerehabilitation Network in Pediatric Patients With Complex Neurodisabilities MedeaNeuroTelerehab-Net (MENTE.NET Study)

NCT06450717 | Completed

• 1 other identifier: 850
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

This pilot study aims at networking the experience gained in neurorehabilitation of developmental neurodisabilities from the 3 poles of IRCCS Medea (Brindisi, Bosisio Parini, and Conegliano) to assess the feasibility of performing home-based telerehabilitation on cognitive and motor aspects through the Khymeia Virtual Reality Rehabilitation System (VRRS) platform.

Conditions

Neurological Diseases or Conditions

Keywords

Neurological condition; Telerehabilitation

Outcome Measures

Primary Outcomes (23)

• True or False? (VRRS Task - executive functioning)

  The task requires the participant to answer true or false to statements that describe the mug design on the screen. As you advance in level, the features to be considered increase (e.g., color, number of objects, presence or absence of certain objects, etc.). The test aims to assess observation skills, comprehension and working memory. The test lasts 5 minutes and you will pass the level after 4 consecutive correct answers. The correctness of the answers and the number of total repetitions made are evaluated. There are no cutoff points. However, raw scores can be statistically analyzed for evaluation changes in individual performance pre- and post-intervention.

  baseline (immediately pre-training)

• True or False? (VRRS Task - executive functioning)

  The task requires the participant to answer true or false to statements that describe the mug design on the screen. As you advance in level, the features to be considered increase (e.g., color, number of objects, presence or absence of certain objects, etc.). The test aims to assess observation skills, comprehension and working memory. The test lasts 5 minutes and you will pass the level after 4 consecutive correct answers. The correctness of the answers and the number of total repetitions made are evaluated. There are no cutoff points. However, raw scores can be statistically analyzed for evaluation changes in individual performance pre- and post-intervention.

  post-training (approximatively at week 4)

• Bells Test

  This is a cancellation task and it gives a measure of visual selective attention. It requires participants to mark all the bells in 4 consecutives sheets. It gives both a measure of rapidity and accuracy. The task consists of 4 parts (4 visual research sheets presented in succession). For each of them there is a maximum time of 120 seconds. The accuracy score corresponds to the total number of bells found in the 120 seconds for each sheet. The quickness score corresponds to the total number of bells found in the first 30 seconds for each sheet. For both accuracy and rapidity scores, the z score ((score-average)/standard deviation) is calculated. A score below z= -2 indicates a poor performance.

  baseline (immediately pre-training)

• Bells Test

  This is a cancellation task and it gives a measure of visual selective attention. It requires participants to mark all the bells in 4 consecutives sheets. It gives both a measure of rapidity and accuracy. The task consists of 4 parts (4 visual research sheets presented in succession). For each of them there is a maximum time of 120 seconds. The accuracy score corresponds to the total number of bells found in the 120 seconds for each sheet. The quickness score corresponds to the total number of bells found in the first 30 seconds for each sheet. For both accuracy and rapidity scores, the z score ((score-average)/standard deviation) is calculated. A score below z= -2 indicates a poor performance.

  post-training (approximatively at week 4)

• Visual attention (NEPSY II task)

  This is a cancellation task and it gives a measure of visual selective attention. It requires participants to mark all faces corresponding to the target faces printed on two sheets among similar faces (distractors). The allotted time is 180 seconds. The raw score is converted to a standard score. Standard scores between 8 and 12 are within the normal range. They turn out to be lower than expected when less than 8.

  baseline (immediately pre-training)

• Visual attention (NEPSY II task)

  This is a cancellation task and it gives a measure of visual selective attention. It requires participants to mark all faces corresponding to the target faces printed on two sheets among similar faces (distractors). The allotted time is 180 seconds. The raw score is converted to a standard score. Standard scores between 8 and 12 are within the normal range. They turn out to be lower than expected when less than 8.

  post-training (approximatively at week 4)

• Attention and concentration software (exercise 3)

  The test requires a computer and includes three different exercises that measure auditory, visual and spatial attention, respectively. It gives a measure of rapidity and accuracy for each type of exercise. There is no advancement level, it is administered at level 1 only. Tables are available for all the tests in this CD that allow you to see the reference percentile (for errors) and to calculate the z-point (for the velocity dimension). Each table shows the number of errors that corresponds to the lowest quartile (25%). A number of errors exceeding this score is considered an indication of poor performance. Regarding speed, the tables report averages and standard deviations and allow calculation of the z-point. As above scores below z -2 indicate poor performance.

  baseline (immediately pre-training)

• Attention and concentration software (exercise 3)

  The test requires a computer and includes three different exercises that measure auditory, visual and spatial attention, respectively. It gives a measure of rapidity and accuracy for each type of exercise. There is no advancement level, it is administered at level 1 only. Tables are available for all the tests in this CD that allow you to see the reference percentile (for errors) and to calculate the z-point (for the velocity dimension). Each table shows the number of errors that corresponds to the lowest quartile (25%). A number of errors exceeding this score is considered an indication of poor performance. Regarding speed, the tables report averages and standard deviations and allow calculation of the z-point. As above scores below z -2 indicate poor performance.

  post-training (approximatively at week 4)

• Melbourne Assessment of Unilateral Upper Limb Function

  MA2 evaluates 4 elements (Range of movement, Accuracy of reach and placement, Dexterity of grasp, release and manipulation, and Fluency of movement) of upper limb movement quality in children (2.5-15 y.o.) with a neurological impairment. The full test requires the child to reach to, grasp, release and manipulate simple objects, and each performance is video recorded. Scoring is completed across the 30 score items using a 3, 4 or 5-point scale and individually defined scoring criteria. Item scores relating to each element of movement measured are summed within the corresponding sub-scale. A final score is reported as 4 separate scores (one for each element measured). A raw score for each sub-scale is converted to a percentage of the maximum possible score for that sub-scale. There are no cutoff points. However, raw scores can be statistically analyzed for evaluation changes in an individual's performance pre- and post-intervention.

  baseline (immediately pre-training)

• Melbourne Assessment of Unilateral Upper Limb Function

  MA2 evaluates 4 elements (Range of movement, Accuracy of reach and placement, Dexterity of grasp, release and manipulation, and Fluency of movement) of upper limb movement quality in children (2.5-15 y.o.) with a neurological impairment. The full test requires the child to reach to, grasp, release and manipulate simple objects, and each performance is video recorded. Scoring is completed across the 30 score items using a 3, 4 or 5-point scale and individually defined scoring criteria. Item scores relating to each element of movement measured are summed within the corresponding sub-scale. A final score is reported as 4 separate scores (one for each element measured). A raw score for each sub-scale is converted to a percentage of the maximum possible score for that sub-scale. There are no cutoff points. However, raw scores can be statistically analyzed for evaluation changes in an individual's performance pre- and post-intervention.

  post-training (approximatively at week 3)

• Melbourne Assessment of Unilateral Upper Limb Function

  MA2 evaluates 4 elements (Range of movement, Accuracy of reach and placement, Dexterity of grasp, release and manipulation, and Fluency of movement) of upper limb movement quality in children (2.5-15 y.o.) with a neurological impairment. The full test requires the child to reach to, grasp, release and manipulate simple objects, and each performance is video recorded. Scoring is completed across the 30 score items using a 3, 4 or 5-point scale and individually defined scoring criteria. Item scores relating to each element of movement measured are summed within the corresponding sub-scale. A final score is reported as 4 separate scores (one for each element measured). A raw score for each sub-scale is converted to a percentage of the maximum possible score for that sub-scale. There are no cutoff points. However, raw scores can be statistically analyzed for evaluation changes in an individual's performance pre- and post-intervention.

  follow up (approximatively 1 month post-training)

• Scala Besta

  The Besta scale evaluates hand grip on request with standard material (1.5-3.5 cm dice), spontaneous use with game material that implies bimanuality and spontaneous use of the hand in praxis activities (with proposals for independent activities such as feeding, cleaning, clothing). The assessment is intended for use with children aged 6 to 12 years. There are no cutoff points. However, raw scores can be statistically analyzed for evaluation changes in individual's performance pre- and post-intervention.

  baseline (immediately pre-training)

• Scala Besta

  The Besta scale evaluates hand grip on request with standard material (1.5-3.5 cm dice), spontaneous use with game material that implies bimanuality and spontaneous use of the hand in praxis activities (with proposals for independent activities such as feeding, cleaning, clothing). The assessment is intended for use with children aged 6 to 12 years. There are no cutoff points. However, raw scores can be statistically analyzed for evaluation changes in individual's performance pre- and post-intervention.

  post-training (approximatively at week 3)

• Scala Besta

  The Besta scale evaluates hand grip on request with standard material (1.5-3.5 cm dice), spontaneous use with game material that implies bimanuality and spontaneous use of the hand in praxis activities (with proposals for independent activities such as feeding, cleaning, clothing). The assessment is intended for use with children aged 6 to 12 years. There are no cutoff points. However, raw scores can be statistically analyzed for evaluation changes in individual's performance pre- and post-intervention.

  follow up (approximatively 1 month post-training)

• Movement Assessment Battery for Children (M-ABC)-II

  The M-ABC was specifically developed for identifying and evaluating children with mild to moderate motor impairment. The test is divided into three age groups (3-6; 7-10; 11-16). For each age group, eight tasks are provided, grouped into three sections: manual dexterity, aiming and catching, and balance. Raw scores for each of the tasks and for each age group can be converted into standard scores (with a mean of 10 and a standard deviation of 3) and percentiles. A standard score equivalent to the 5th percentile is considered pathological. In our study, we will administer the same test evaluating manual dexterity to all subjects (regardless of age) and analyze the changes in raw scores between pre- and post-intervention.

  baseline (immediately pre-training)

• Movement Assessment Battery for Children (M-ABC)-II

  The M-ABC was specifically developed for identifying and evaluating children with mild to moderate motor impairment. The test is divided into three age groups (3-6; 7-10; 11-16). For each age group, eight tasks are provided, grouped into three sections: manual dexterity, aiming and catching, and balance. Raw scores for each of the tasks and for each age group can be converted into standard scores (with a mean of 10 and a standard deviation of 3) and percentiles. A standard score equivalent to the 5th percentile is considered pathological. In our study, we will administer the same test evaluating manual dexterity to all subjects (regardless of age) and analyze the changes in raw scores between pre- and post-intervention.

  post-training (approximatively at week 3)

• Movement Assessment Battery for Children (M-ABC)-II

  The M-ABC was specifically developed for identifying and evaluating children with mild to moderate motor impairment. The test is divided into three age groups (3-6; 7-10; 11-16). For each age group, eight tasks are provided, grouped into three sections: manual dexterity, aiming and catching, and balance. Raw scores for each of the tasks and for each age group can be converted into standard scores (with a mean of 10 and a standard deviation of 3) and percentiles. A standard score equivalent to the 5th percentile is considered pathological. In our study, we will administer the same test evaluating manual dexterity to all subjects (regardless of age) and analyze the changes in raw scores between pre- and post-intervention.

  follow up (approximatively 1 month post-training)

• System Usability Scale (SUS) for PCI

  SUS is a quick and dirty survey scale that assess the usability of a give product or service. It is composed of 10 statements that are scored on a 5-point scale of strength of agreement. Final score for the SUS can range from 0 to 100, where higher scores indicate better usability. A product with a score greater than 70 indicates a product with good usability.

  baseline (immediately pre-training)

• System Usability Scale (SUS) for SMA

  SUS is a quick and dirty survey scale that assess the usability of a give product or service. It is composed of 10 statements that are scored on a 5-point scale of strength of agreement. Final score for the SUS can range from 0 to 100, where higher scores indicate better usability. A product with a score greater than 70 indicates a product with good usability.

  post-training (approximatively at week 3)

• Revised Hammersmith Scale (RHS)

  The RHS is a clinician rated SMA specific outcome measure containing 36 items which assess physical motor performance. The scale assesses motor functional activities related to sitting, supine, rolling, prone, ability to move and get up from the floor, balance, standing, run/ walk, stairs, ascending and descending a step and the ability to jump. Thirty-three items are graded according to an ordinal 0, 1, 2 scale where 0 represents the least physical ability or function achieved, and 2 the highest. Three items are graded 0 and 1 where 0 represents an inability to complete the item, and 1 represents achieving the item. There are no cutoff points. However, scores can be statistically analyzed for evaluation changes in an individual's performance pre- and post-intervention.

  baseline (immediately pre-training)

• Revised Hammersmith Scale (RHS)

  The RHS is a clinician rated SMA specific outcome measure containing 36 items which assess physical motor performance. The scale assesses motor functional activities related to sitting, supine, rolling, prone, ability to move and get up from the floor, balance, standing, run/ walk, stairs, ascending and descending a step and the ability to jump. Thirty-three items are graded according to an ordinal 0, 1, 2 scale where 0 represents the least physical ability or function achieved, and 2 the highest. Three items are graded 0 and 1 where 0 represents an inability to complete the item, and 1 represents achieving the item. There are no cutoff points. However, scores can be statistically analyzed for evaluation changes in an individual's performance pre- and post-intervention.

  post-training (approximatively at week 3)

• Revised Upper Limb Module (RULM) Scale

  The scale consists of an entry item to establish functional levels and 19 items covering distal to proximal movements. The entry item is a modified version of the Brooke scale, including activities ranging from no functional use of hands (score 0) to full bilateral shoulder abduction (score 6). The entry item does not contribute to the total score but serves as a functional classification of overall upper limb functional ability. Of the remaining 19 items, 18 are scoredon a 3 point scoring system and 1 item is scored on a 2 point scoring system. The total score ranges from 0, if all the items cannot be performed, to 37, if all the activities are achieved fullywithout any compensation. There are no cutoff points. However, scores can be statistically analyzed for evaluation changes in an individual's performance pre- and post-intervention.

  baseline (immediately pre-training)

• Revised Upper Limb Module (RULM) Scale

  The scale consists of an entry item to establish functional levels and 19 items covering distal to proximal movements. The entry item is a modified version of the Brooke scale, including activities ranging from no functional use of hands (score 0) to full bilateral shoulder abduction (score 6). The entry item does not contribute to the total score but serves as a functional classification of overall upper limb functional ability. Of the remaining 19 items, 18 are scoredon a 3 point scoring system and 1 item is scored on a 2 point scoring system. The total score ranges from 0, if all the items cannot be performed, to 37, if all the activities are achieved fullywithout any compensation. There are no cutoff points. However, scores can be statistically analyzed for evaluation changes in an individual's performance pre- and post-intervention.

  post-training (approximatively at week 3)

Secondary Outcomes (5)

• Pediatric Quality of Life Inventor (PedsQLTM) for PCI

  baseline (immediately pre-training)

• Pediatric Quality of Life Inventor (PedsQLTM) for PCI

  post-training (approximatively at week 3)

• Pediatric Quality of Life Inventor (PedsQLTM) for PCI

  follow up (approximatively 1 month post-training)

• Pediatric Quality of Life Inventor (PedsQLTM) for SMA

  baseline (immediately pre-training)

• Pediatric Quality of Life Inventor (PedsQLTM) for SMA

  post-training (approximatively at week 3)

Study Arms (1)

VRRS group

EXPERIMENTAL

Participants will receive telerehabilitation treatment based delivered by Khymeia VRRS technology platform. The VRRS device, in the home version, is used in tele-rehabilitation mode. There are two modes of operation in tele-rehabilitation: on line mode: the therapist is able to take control of the system remotely and interact with the patient in real time through the integrated two-way video conferencing system with pan and zoom camera with which the VRRS is equipped; off-line mode: the therapist can prepare a list of exercises to be performed by the patient at home, assisted by the "smart virtual assistant" who guides the patient in the execution of the rehabilitation program. The home device automatically records all activities performed by the patient independently. The therapist can connect to the home device at any time to review the tests performed or modify the exercise list or make appropriate changes to the specific patient's rehabilitation program.

Device: Khymeia VRRS

Interventions

Khymeia VRRS DEVICE

VRRS is an electronic device for remote rehabilitation of cognitive (e.g., memory, attention, spatial perception, logical-mathematical skills, language, executive functions...) and motor (gross and fine motor skills) functions. It can be used in on-line and off-line mode at home, and the exercises are chosen by the therapist according to the patient's specific difficulties and needs from a cognitive and motor library.

Also known as: VRRS

VRRS group

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• congenital or acquired, cognitive or motor neurodisability;
• cooperation and abiity to understand the offered activities;
• where necessary, parents or legal guardians able to commit to and cooperate in a home-based telerehabilitation program.

You may not qualify if:

• Developmental disorders;
• Psychiatric disorders.

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (3)

Alessandra Bardoni

Bosisio Parini, Lecco, 23842, Italy

Location

Andrea Martinuzzi

Conegliano, Treviso, 31015, Italy

Location

Antonio Trabacca

Brindisi, 72100, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a two-year multicenter prospective clinical-experimental study. The project involves the initial small-scale application of a telerehabilitation study protocol to test whether the methodology is appropriate, establish its feasibility, and derive useful information for sample size calculation for subsequent randomized trials. For prospective data collection, patients will be consecutively enrolled at participating centers. At least 10 patients (age 4-18) per pole are expected to be enrolled in this pilot phase.

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 10, 2024
• Study Start: December 28, 2022
• Primary Completion: June 9, 2024
• Study Completion: June 9, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

IT (3)