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

CompletedNot a drug-phase studyMS (type not specified)NCT04367285

What it found

No results found

We found no results in the registry or in papers.

This trial finished 7 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Sensor-based Training

Compared with

  • Upper limb motor training

What it measured

Main measures

  • Changes in functionality of the upper limb measured in 9 Hole Peg Test (9HPT) at 1 months

    1 month

    Disability progressionArm and hand function

Other measures (4)

  • Fatigue Level at 1 month

    1 month

    Fatigue
  • 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

    Thinking and memoryFatigueBladder, bowel and sexual functionPainQuality of life (reported by participants)
  • Changes of Medical Research Council scale (MRC) at 1 month

    1 month

    Arm and hand function

Who could take part

MS (type not specified) · 30 to 70

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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)

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History

    1. Started

      Mar 2017

    2. Main results due

      Nov 2019

    3. Finished

      Jan 2020

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