Sensor-based Technology for Upper Limb Rehabilitation

NCT04367285 | Completed

• 1 other identifier: FSLCE/PROG.631
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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)

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Fatigue Level at 1 month

  1 month

• Modified Barthel Index (MBI) at 1 month

  1 month

• Changes in Multiple Sclerosis Quality of Life-54 questionnaire (MSQOL-54)at 1 month

  1 month

• Changes of Medical Research Council scale (MRC) at 1 month

  1 month

Study Arms (2)

Sensor-based Training

EXPERIMENTAL

Other: Sensor-based Training

Upper limb motor training

ACTIVE COMPARATOR

Other: Upper limb motor training

Interventions

Sensor-based Training OTHER

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.

Sensor-based Training

Upper limb motor training OTHER

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.

Upper limb motor training

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of Multiple Sclerosis
• upper limb deficits,
• disability between 5 and 8.5 on the Expanded Disability Status Scale (EDSS).

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead

Study Sites (1)

Marco Tramontano

Rome, 00179, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marco Tramontano

  SANTA LUCIA FOUNDATION

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of rehabilitation Services

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 29, 2020
• Study Start: March 1, 2017
• Primary Completion: November 4, 2019
• Study Completion: January 31, 2020
• Last Updated: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)