Sensor-based Technology for Upper Limb Rehabilitation

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04367285
• Other study ID #: FSLCE/PROG.631
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: January 31, 2020

Study information

• Verified date: April 2020
• Source: I.R.C.C.S. Fondazione Santa Lucia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 31, 2020
• Est. primary completion date: November 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Marco Tramontano	Rome

Sponsors (1)

Lead Sponsor	Collaborator
I.R.C.C.S. Fondazione Santa Lucia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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