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User-centred Assistive System for Arm Functions in Neuromuscular Subjects (USEFUL)

Primary Purpose

Muscular Dystrophies, Muscular Dystrophy, Duchenne, Muscular Dystrophy, Becker

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Assistive device (Armon Ayura) test
Assistive device (Jaeco Wrex) test
Sponsored by
Politecnico di Milano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Muscular Dystrophies focused on measuring Assistive devices, Randomized controlled trial (RCT), Upper limbs, Robotic devices

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • signed informed consent (we will expose the family the aims of our study and carefully describe the need of compliance with them)
  • diagnosis of muscular dystrophy (genetic, histological and biochemical if necessary),specifically with Duchenne, Becker and Limb Girdle type 2 muscular dystrophy. No muscle biopsy will be performed, except in case there is a diagnostic need.
  • being wheelchair bound
  • having a scoring at the MRC scale for upper limb at the deltoid, biceps, triceps brachii muscles ranging from 2 to 4.

Exclusion criteria

  • presence of additional diseases (for example: family history of mental retardation, epilepsy, cerebral palsy)
  • behavioral and psychiatric disturbances (emotional problems, depression)
  • absence of compliance to the study of the family and the caregivers

Sites / Locations

  • IRCCS E. Medea - La Nostra Famiglia
  • Villa Beretta

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Armon Ayura

Jaeco Wrex

Arm Description

Upper limb assistive device with active solutions for gravity compensation. Intervention: The upper limb exoskeleton is worn by the patient on the preferred arm, and it is used during daily life activities to support arm movements, particularly getting rid of gravity arm weight.

Upper limb assistive device with passive solutions for gravity compensation. Intervention: The upper limb exoskeleton is worn by the patient on the preferred arm, and it is used during daily life activities to support arm movements, particularly getting rid of gravity arm weight.

Outcomes

Primary Outcome Measures

Performance of the Upper Limb (PUL) scale
The PUL includes 22 items with an entry item to define the starting functional level, and 21 items subdivided into shoulder level (4 items), middle level (9 items) and distal level (8 items) dimension. For weaker patients a low score on the entry item means high level items do not need to be performed. Scoring options vary across the scale between 0-1 to 0-6 according to performance. Each dimension can be scored separately with a maximum score of 16 for the shoulder level, 34 for the middle level, and 24 for the distal level . A total score can be achieved by adding the three level scores (max total score 74).

Secondary Outcome Measures

Motor Function Measures scale (MFM)
MFM is a quantitative scale that makes it possible to measure the functional motor abilities of a person affected by a neuromuscular disease.
Brooke scale
The Brooke scale was designed to assess the upper extremity function. The grades of the Brooke scale range from 1 to 6; 1 means that the subject can elevate their arms full range to the head with the arms straight; while 2 means that the shoulder strength is insufficient to elevate their arms and the subject needs to flex the elbow to elevate the arms; in grades 3 and 4, the subject is unable to elevate the shoulders but can raise hands to the mouth with or without weight respectively; grade 5 refers to the subject being unable to raise hands to the mouth and only some hand movement exists, while grade 6 refers to no useful function of hands.
ABILHAND
a measure of manual ability to manage daily activities that require the use of the upper limbs, whatever the strategies involved
PedsQL
Neuromuscular module: composed of 25 items comprising 3 dimensions, i.e. about my neuromuscular disease (1-17); communication (1-3); and about our faily resources (1-5) Multidimensional Fatigue module: composed of 18 items comprising 3 dimensions, i.e. general fatigue (1-6); sleep/rest fatigue (1-6); and cognitive fatigue (1-6).
PROMIS FATIGUE Short Form
The PROMIS Fatigue instruments evaluate a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The Fatigue short form is universal rather than disease-specific. It assesses fatigue over the past seven days.
Personal Adjustment and Role Skills Scale (PARS) III
PARS III to assesses the psychosocial adjustment of children with chronic physical illnesses and no mental impairment. The PARS III consists of 28 items that measure psychosocial functioning in six areas: peer relations, dependency, hostility, productivity, anxiety-depression, and withdrawal.
Technology Acceptance Model (TAM)
Technology Acceptance Model (TAM) provides a valid and reliable measure that predicts the acceptance or adoption of new technologies by end-users. TAM predicts acceptance based on the end-user's perceived usefulness (6 items) and perceived ease of use (6 items) of the technology for a specific purpose.
System Usability Scale (SUS)
the system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability. Measurements of usability have several different aspects: effectiveness (can users successfully achieve their objectives); efficiency (how much effort and resource is expended in achieving those objectives); and satisfaction (was the experience satisfactory).

Full Information

First Posted
April 20, 2017
Last Updated
December 9, 2019
Sponsor
Politecnico di Milano
Collaborators
IRCCS Eugenio Medea, Villa Beretta Rehabilitation Center
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1. Study Identification

Unique Protocol Identification Number
NCT03127241
Brief Title
User-centred Assistive System for Arm Functions in Neuromuscular Subjects
Acronym
USEFUL
Official Title
USEFUL: User-centred Assistive SystEm for Arm Functions in neUromuscuLar Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 16, 2017 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Politecnico di Milano
Collaborators
IRCCS Eugenio Medea, Villa Beretta Rehabilitation Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Restore a lost function is a special experience for people affected by neuromuscular evolutive diseases. "From the patient's point of view improvement is measured by regaining lost abilities,-by being able to do something -anything-today I couldn't do yesterday ". Upper limb pain, stiffness and activity limitations have a crucial role in reducing patients' autonomy and worsening quality of life. Real users' needs have been identified thought several workshops, and even if the commercial products might assure a benefit to some users and meet most of their requirements, so far a validation of the use of such devices by people with neuromuscular disease is missing. We aim at field-testing the improvement in arm functions provided by the use of some commercial devices and assessing their impact to users' quality of life and independence. This step is essential to assure a widespread accessibility to these devices for most of the potential users, possibly providing health providers with direction and guidance towards Health Technology Assessment. Clinical Trial design - The study proposes on-field validation of JAECO WREX, passive antigravity exoskeleton; and Armon Ayura, motorized arm exoskeleton for gravity compensation in a randomized controlled trial with crossover design. The clinical study will is multi-centric, involving both MEDEA and VALDUCE, and received the Ethical Committee approval.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Dystrophies, Muscular Dystrophy, Duchenne, Muscular Dystrophy, Becker, Muscular Dystrophy, Limb-Girdle Type 2
Keywords
Assistive devices, Randomized controlled trial (RCT), Upper limbs, Robotic devices

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Armon Ayura
Arm Type
Active Comparator
Arm Description
Upper limb assistive device with active solutions for gravity compensation. Intervention: The upper limb exoskeleton is worn by the patient on the preferred arm, and it is used during daily life activities to support arm movements, particularly getting rid of gravity arm weight.
Arm Title
Jaeco Wrex
Arm Type
Active Comparator
Arm Description
Upper limb assistive device with passive solutions for gravity compensation. Intervention: The upper limb exoskeleton is worn by the patient on the preferred arm, and it is used during daily life activities to support arm movements, particularly getting rid of gravity arm weight.
Intervention Type
Device
Intervention Name(s)
Assistive device (Armon Ayura) test
Intervention Description
Short Training (T0-T1) - each subject will undergo a 3-day training at the clinical center during which technicians, along with a physiotherapist will adjust and customize the device and explain possible independent use at home. Domestic use (T1-T2) - Subjects will use the device during their daily life activities for two weeks at home. They will perform task-oriented movements (e.g. reaching a mouse and objects on a table, moving back to the wheelchair, drinking), free movements, playful activities (e.g. playing chess, leafing through a book), and self-care activities, accordingly to subject's residual capability, for a minimum period of 5 hours/day. They will keep a structured diary where all the problems, achievements and comments will be reported.
Intervention Type
Device
Intervention Name(s)
Assistive device (Jaeco Wrex) test
Intervention Description
Short Training (T0-T1) - each subject will undergo a 3-day training at the clinical center during which technicians, along with a physiotherapist will adjust and customize the device and explain possible independent use at home. Domestic use (T1-T2) - Subjects will use the device during their daily life activities for two weeks at home. They will perform task-oriented movements (e.g. reaching a mouse and objects on a table, moving back to the wheelchair, drinking), free movements, playful activities (e.g. playing chess, leafing through a book), and self-care activities, accordingly to subject's residual capability, for a minimum period of 5 hours/day. They will keep a structured diary where all the problems, achievements and comments will be reported.
Primary Outcome Measure Information:
Title
Performance of the Upper Limb (PUL) scale
Description
The PUL includes 22 items with an entry item to define the starting functional level, and 21 items subdivided into shoulder level (4 items), middle level (9 items) and distal level (8 items) dimension. For weaker patients a low score on the entry item means high level items do not need to be performed. Scoring options vary across the scale between 0-1 to 0-6 according to performance. Each dimension can be scored separately with a maximum score of 16 for the shoulder level, 34 for the middle level, and 24 for the distal level . A total score can be achieved by adding the three level scores (max total score 74).
Time Frame
T0 (baseline); T1 (after 3-days short training with device 1); T2 (after 2-weeks home use of device 1 - primary assessment point); T3 (after 3-days short training with device 2); T4 (after 2-weeks home use of device 2 - secondary assessment point)
Secondary Outcome Measure Information:
Title
Motor Function Measures scale (MFM)
Description
MFM is a quantitative scale that makes it possible to measure the functional motor abilities of a person affected by a neuromuscular disease.
Time Frame
T0 (baseline); T1 (after 3-days short training with device 1); T2 (after 2-weeks home use of device 1 - primary assessment point); T3 (after 3-days short training with device 2); T4 (after 2-weeks home use of device 2 - secondary assessment point)
Title
Brooke scale
Description
The Brooke scale was designed to assess the upper extremity function. The grades of the Brooke scale range from 1 to 6; 1 means that the subject can elevate their arms full range to the head with the arms straight; while 2 means that the shoulder strength is insufficient to elevate their arms and the subject needs to flex the elbow to elevate the arms; in grades 3 and 4, the subject is unable to elevate the shoulders but can raise hands to the mouth with or without weight respectively; grade 5 refers to the subject being unable to raise hands to the mouth and only some hand movement exists, while grade 6 refers to no useful function of hands.
Time Frame
T0 (baseline); T1 (after 3-days short training with device 1); T2 (after 2-weeks home use of device 1 - primary assessment point); T3 (after 3-days short training with device 2); T4 (after 2-weeks home use of device 2 - secondary assessment point)
Title
ABILHAND
Description
a measure of manual ability to manage daily activities that require the use of the upper limbs, whatever the strategies involved
Time Frame
T0 (baseline); T1 (after 3-days short training with device 1); T2 (after 2-weeks home use of device 1 - primary assessment point); T3 (after 3-days short training with device 2); T4 (after 2-weeks home use of device 2 - secondary assessment point)
Title
PedsQL
Description
Neuromuscular module: composed of 25 items comprising 3 dimensions, i.e. about my neuromuscular disease (1-17); communication (1-3); and about our faily resources (1-5) Multidimensional Fatigue module: composed of 18 items comprising 3 dimensions, i.e. general fatigue (1-6); sleep/rest fatigue (1-6); and cognitive fatigue (1-6).
Time Frame
T0 (baseline); T2 (after 2-weeks home use of device 1 - primary assessment point); T4 (after 2-weeks home use of device 2 - secondary assessment point)
Title
PROMIS FATIGUE Short Form
Description
The PROMIS Fatigue instruments evaluate a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The Fatigue short form is universal rather than disease-specific. It assesses fatigue over the past seven days.
Time Frame
T0 (baseline); T2 (after 2-weeks home use of device 1 - primary assessment point); T4 (after 2-weeks home use of device 2 - secondary assessment point)
Title
Personal Adjustment and Role Skills Scale (PARS) III
Description
PARS III to assesses the psychosocial adjustment of children with chronic physical illnesses and no mental impairment. The PARS III consists of 28 items that measure psychosocial functioning in six areas: peer relations, dependency, hostility, productivity, anxiety-depression, and withdrawal.
Time Frame
T0 (baseline); T2 (after 2-weeks home use of device 1 - primary assessment point); T4 (after 2-weeks home use of device 2 - secondary assessment point)
Title
Technology Acceptance Model (TAM)
Description
Technology Acceptance Model (TAM) provides a valid and reliable measure that predicts the acceptance or adoption of new technologies by end-users. TAM predicts acceptance based on the end-user's perceived usefulness (6 items) and perceived ease of use (6 items) of the technology for a specific purpose.
Time Frame
T2 (after 2-weeks home use of device 1 - primary assessment point); T3 (after 3-days short training with device 2); T4 (after 2-weeks home use of device 2 - secondary assessment point)
Title
System Usability Scale (SUS)
Description
the system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability. Measurements of usability have several different aspects: effectiveness (can users successfully achieve their objectives); efficiency (how much effort and resource is expended in achieving those objectives); and satisfaction (was the experience satisfactory).
Time Frame
T2 (after 2-weeks home use of device 1 - primary assessment point); T3 (after 3-days short training with device 2); T4 (after 2-weeks home use of device 2 - secondary assessment point)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria signed informed consent (we will expose the family the aims of our study and carefully describe the need of compliance with them) diagnosis of muscular dystrophy (genetic, histological and biochemical if necessary),specifically with Duchenne, Becker and Limb Girdle type 2 muscular dystrophy. No muscle biopsy will be performed, except in case there is a diagnostic need. being wheelchair bound having a scoring at the MRC scale for upper limb at the deltoid, biceps, triceps brachii muscles ranging from 2 to 4. Exclusion criteria presence of additional diseases (for example: family history of mental retardation, epilepsy, cerebral palsy) behavioral and psychiatric disturbances (emotional problems, depression) absence of compliance to the study of the family and the caregivers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandra Pedrocchi, Prof
Organizational Affiliation
Politecnico di Milano
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS E. Medea - La Nostra Famiglia
City
Bosisio Parini
State/Province
LC
ZIP/Postal Code
23842
Country
Italy
Facility Name
Villa Beretta
City
Costa Masnaga
State/Province
LC
ZIP/Postal Code
23845
Country
Italy

12. IPD Sharing Statement

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User-centred Assistive System for Arm Functions in Neuromuscular Subjects

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