Sensor-based Technology for Upper Limb Rehabilitation

NCT ID: NCT04367285

Last Updated: 2020-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2020-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sensor-based Training

Group Type: EXPERIMENTAL

Sensor-based Training

Intervention Type: 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.

Upper limb motor training

Group Type: ACTIVE_COMPARATOR

Upper limb motor training

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I.R.C.C.S. Fondazione Santa Lucia

OTHER

Sponsor Role: lead

Responsible Party

Marco Tramontano

head of rehabilitation Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marco Tramontano

Role: PRINCIPAL_INVESTIGATOR

SANTA LUCIA FOUNDATION

Locations

Marco Tramontano

Rome, , Italy

Countries

Italy

Other Identifiers

FSLCE/PROG.631

Identifier Type: -

Identifier Source: org_study_id