Sensor-based Technology for Upper Limb Rehabilitation in Subject With Multiple Sclerosis: a Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Changes in functionality of the upper limb measured in 9 Hole Peg Test (9HPT) at 1 months
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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)
Investigators
Marco Tramontano
head of rehabilitation Services
I.R.C.C.S. Fondazione Santa Lucia
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.
Outcomes
Primary Outcomes
Changes in functionality of the upper limb measured in 9 Hole Peg Test (9HPT) at 1 months
Time Frame: 1 month
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 Outcomes
- Modified Barthel Index (MBI) at 1 month(1 month)
- Changes of Medical Research Council scale (MRC) at 1 month(1 month)
- Fatigue Level at 1 month(1 month)
- Changes in Multiple Sclerosis Quality of Life-54 questionnaire (MSQOL-54)at 1 month(1 month)