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Sensor-based Technology for Upper Limb Rehabilitation

I

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

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Other: Sensor-based Training
Other: Upper limb motor training

Study type

Interventional

Funder types

Other

Identifiers

NCT04367285
FSLCE/PROG.631

Details and patient eligibility

About

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)

Enrollment

35 patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

35 participants in 2 patient groups

Sensor-based Training
Experimental group
Treatment:
Other: Sensor-based Training
Upper limb motor training
Active Comparator group
Treatment:
Other: Upper limb motor training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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