Sensor-based Technology for Upper Limb Rehabilitation

Sensor-based Technology for Upper Limb Rehabilitation in Subject With Multiple Sclerosis: a Randomized Controlled Trial

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)

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Sensor-based Training; Other: Upper limb motor training

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00179
    • Marco Tramontano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sensor-based Training	Other: Sensor-based Training; 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.
Active Comparator: Upper limb motor training	Other: Upper limb motor training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 month
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.	1 month
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.	1 month
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.	1 month

Collaborators and Investigators

• Sponsor: I.R.C.C.S. Fondazione Santa Lucia
• Investigators: Principal Investigator: Marco Tramontano, Santa Lucia foundation

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): November 4, 2019
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 25, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 25, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: FSLCE/PROG.631

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No