Sensor-based Technology for Upper Limb Rehabilitation
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Sensor-based Training
Upper limb motor training
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
- diagnosis of Multiple Sclerosis
- upper limb deficits,
- disability between 5 and 8.5 on the Expanded Disability Status Scale (EDSS).
Exclusion Criteria:
- Modified Ashworth Scale (MAS) < 3 at the upper limb;
- cognitive deficits affecting the ability to understand task instructions (Mini-Mental State Examination < 24
- Medical Research Council (MRC) scale with score 0 or 5;
- presence of clinically evaluated severe comorbidities; pregnancy;
- subjects with artificial pacemaker;
- subjects involved in other studies.
Sites / Locations
- Marco Tramontano
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sensor-based Training
Upper limb motor training
Arm Description
Outcomes
Primary Outcome Measures
Changes in functionality of the upper limb measured in 9 Hole Peg Test (9HPT) at 1 months
Changes in functionality of the upper limb measured in 9-HPT. Changes in the measure in 9-HPT (time, seconds *total scale*) Nine Hole PegTest (Mathiowetz et al, Occup Therap J Resaerach 1985) Time in second to perform the whole test will be recordered (better with less time)
Secondary Outcome Measures
Fatigue Level at 1 month
Fatigue Severity Scale (FSS) is one of the most commonly used self-report questionnaires to measure fatigue. Each question on this scale, which is composed of Likert type questions: 1.I strongly disagree 2.I do not agree 3.No tend to disagree 4. Indefinitely. The total score of the scale, which consists of 9 questions, varies between 9-63. People are asked to mark the appropriate options for each question taking into account their status in the last 1 month period. A total of 36 points and above indicate fatigue
Modified Barthel Index (MBI) at 1 month
Change of Modified Barthel Index (MBI) at 1 month. MBI MBI values ranging from 0 to 105, where 0 means the worse outcome and 105 the best one.
Changes in Multiple Sclerosis Quality of Life-54 questionnaire (MSQOL-54)at 1 month
Change from Baseline in MSQOL-54. MSQOL-54 is a multidimensional health-related quality of life measure, assessing the perception of physical and mental well-being. The instrument is composed of 54 items concerning 12 subscales, which form two scales relating to the physical and mental well-being. The score of the physical function scales, perceptions of health, energy/fatigue, role-physical limitations, pain, sexual function, social function, health distress, is added and corrected to obtain a score on the MSQUOL PHYSICAL HEALTH scale: a score above 50.0 indicates physical well-being. The score of the health distress scale, overall quality of life, emotional well-being, role limitations - emotional, cognitive function is summed and corrected to obtain a score on the scale MSQUOL MENTAL HEALTH: a score above 50.0 indicates mental well-being. The administration time is about 11-18 minutes, it can be completed by an interviewer or by the patient.
Changes of Medical Research Council scale (MRC) at 1 month
The MRC score is obtained by evaluating 12 muscle groups in the upper extremities (wrist extensors, elbow flexors and abductors of the shoulder) and lower extremities (dorsal ankle flexors, knee extensors, and hip flexors). For each muscle group will be assigned a score between 0 (complete paralysis) and 5 (normal force), and the total score can vary between 0 up to 60 points.
Full Information
NCT ID
NCT04367285
First Posted
April 24, 2020
Last Updated
April 25, 2020
Sponsor
I.R.C.C.S. Fondazione Santa Lucia
1. Study Identification
Unique Protocol Identification Number
NCT04367285
Brief Title
Sensor-based Technology for Upper Limb Rehabilitation
Official Title
Sensor-based Technology for Upper Limb Rehabilitation in Subject With Multiple Sclerosis: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
November 4, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I.R.C.C.S. Fondazione Santa Lucia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Sensor-based technological therapy devices may be good candidates for neuromotor rehabilitation of people with Multiple Sclerosis (MS), especially for treating upper extremities function limitations. The sensor-based device rehabilitation is characterized by interactive therapy games with audio-visual feedback that allows training the movement of shoulders, elbows and wrist, measuring the strength and the active range of motion of upper limb, registering data in an electronic database in order to quantitatively monitoring measures and therapy progress. The aim of this study is to evaluate the effects of sensor-based motor rehabilitation in add-on to the conventional neurorehabilitation, on increasing the upper limbs functions of MS patients. The training consisting of twelve sessions of upper limb training, was compared with twelve sessions of upper limb sensory-motor training, without robotic support. Both rehabilitation programs were performed for 40 minutes three times a week, for 4 weeks, in addition to the conventional therapy. All patients were evaluated at baseline (T0) and after 4 weeks of training (T1)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sensor-based Training
Arm Type
Experimental
Arm Title
Upper limb motor training
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Sensor-based Training
Intervention Description
Sensor-based Training consists of twelve sessions of upper limb training with PABLO®-Tyromotion. For each session the training consists in interactive-games based on virtual reality which allowed a task-oriented approach and a neurocognitive feedback. The exercises require precision tasks and one-dimensional and bidimensional reaction, allowing to train the attention, the strength control and movement control, the coordination and the movement precision. The interactive-games were chosen from those proposed by the Tyromotion PABLO® System.
Intervention Type
Other
Intervention Name(s)
Upper limb motor training
Intervention Description
Upper limb motor training, without robotic support. Subjects performed specific exercises aimed to recovery global upper limb functions, to control hand grasp and to improve hand's fine movements.
Primary Outcome Measure Information:
Title
Changes in functionality of the upper limb measured in 9 Hole Peg Test (9HPT) at 1 months
Description
Changes in functionality of the upper limb measured in 9-HPT. Changes in the measure in 9-HPT (time, seconds *total scale*) Nine Hole PegTest (Mathiowetz et al, Occup Therap J Resaerach 1985) Time in second to perform the whole test will be recordered (better with less time)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Fatigue Level at 1 month
Description
Fatigue Severity Scale (FSS) is one of the most commonly used self-report questionnaires to measure fatigue. Each question on this scale, which is composed of Likert type questions: 1.I strongly disagree 2.I do not agree 3.No tend to disagree 4. Indefinitely. The total score of the scale, which consists of 9 questions, varies between 9-63. People are asked to mark the appropriate options for each question taking into account their status in the last 1 month period. A total of 36 points and above indicate fatigue
Time Frame
1 month
Title
Modified Barthel Index (MBI) at 1 month
Description
Change of Modified Barthel Index (MBI) at 1 month. MBI MBI values ranging from 0 to 105, where 0 means the worse outcome and 105 the best one.
Time Frame
1 month
Title
Changes in Multiple Sclerosis Quality of Life-54 questionnaire (MSQOL-54)at 1 month
Description
Change from Baseline in MSQOL-54. MSQOL-54 is a multidimensional health-related quality of life measure, assessing the perception of physical and mental well-being. The instrument is composed of 54 items concerning 12 subscales, which form two scales relating to the physical and mental well-being. The score of the physical function scales, perceptions of health, energy/fatigue, role-physical limitations, pain, sexual function, social function, health distress, is added and corrected to obtain a score on the MSQUOL PHYSICAL HEALTH scale: a score above 50.0 indicates physical well-being. The score of the health distress scale, overall quality of life, emotional well-being, role limitations - emotional, cognitive function is summed and corrected to obtain a score on the scale MSQUOL MENTAL HEALTH: a score above 50.0 indicates mental well-being. The administration time is about 11-18 minutes, it can be completed by an interviewer or by the patient.
Time Frame
1 month
Title
Changes of Medical Research Council scale (MRC) at 1 month
Description
The MRC score is obtained by evaluating 12 muscle groups in the upper extremities (wrist extensors, elbow flexors and abductors of the shoulder) and lower extremities (dorsal ankle flexors, knee extensors, and hip flexors). For each muscle group will be assigned a score between 0 (complete paralysis) and 5 (normal force), and the total score can vary between 0 up to 60 points.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of Multiple Sclerosis
upper limb deficits,
disability between 5 and 8.5 on the Expanded Disability Status Scale (EDSS).
Exclusion Criteria:
Modified Ashworth Scale (MAS) < 3 at the upper limb;
cognitive deficits affecting the ability to understand task instructions (Mini-Mental State Examination < 24
Medical Research Council (MRC) scale with score 0 or 5;
presence of clinically evaluated severe comorbidities; pregnancy;
subjects with artificial pacemaker;
subjects involved in other studies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Tramontano
Organizational Affiliation
SANTA LUCIA FOUNDATION
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marco Tramontano
City
Rome
ZIP/Postal Code
00179
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sensor-based Technology for Upper Limb Rehabilitation
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