Music Therapy for Rehabilitation in Stroke Patients
Condition: Stroke; Hand Injuries
MeSH terms: Stroke; Hand Injuries
Study type: Interventional

Summary: 
      The study uses a specific hand tracking sensor (Leap Motion Controller) to catch the
      movements of the arm combined with proper pre-defined musical patterns (sonification) in a
      neurologic music therapy perspective. The aim of the experiment is to verify the efficacy of
      sonification technique (compared to usual care) in the hand rehabilitation of patients with
      stroke.
    

Detailed description: 
      Introduction:

      Every year in Italy occur over than 200.000 new stroke cases. The virtual and augmented
      reality offers a valid support to the rehabilitation program by providing objectives
      parameters for the patient evaluation, accelerating the motor recovery process and enhancing
      the motor performance after the discharge. This study uses a specific hand tracking sensor
      (Leap Motion Controller) to catch the movements of the arm combined with proper pre-defined
      musical patterns (sonification) in a neurologic music therapy perspective.

      In addition to its use in relational contexts, in fact, music therapy is widely used in the
      field of rehabilitation, and in particular in the neuromotor rehabilitation, due to the
      impact of the sound, as well as on paralimbic and limbic areas, the areas of the brain
      involved in the movements (motor cortex, supplementary motor area, cerebellum, basal ganglia,
      etc.).

      Recent studies uses sonification for the rehabilitation of the upper limbs assuming a
      replacement of the proprioceptive aspects damaged by the disease thanks to the audio-motor
      feedback. This study, furthermore, exploits the specificities of the Leap Motion Controller
      and the peculiarities of the sound stimuli that accompany the arm movement without requiring
      cognitive tasks.

      Objectives:

        -  To verify through a randomized controlled trial and a suitable motor assessment the
           efficacy of the rehabilitation of the hand in patients with stroke using the
           "sonification" technique

        -  To verify whether the "sonification" technique reduces the fatigue and the pain
           perceived during rehabilitation

        -  Assess the impact of "sonification" technique on patients quality of life

      Materials and Methods:

      In this randomized controlled trial 66 patients with stroke will be recruited and allocated
      in 2 groups. The control group will be undergone to a 35 minutes standard daily
      rehabilitation treatment lasting 4 weeks. The experimental group will be undergone to an
      analogue treatment based on 15 minutes of standard rehabilitation and 20 minutes of exercises
      with sonification. Randomisation will be centralized for the four Units involved in the
      study.

      The intervention will be assessed in blind at the baseline (T0), at the mid-treatment period
      (T1 = 2 weeks), at the end of the treatment (T2 = 4 weeks), and at a follow-up point (T3 = 8
      weeks).

      The following assessment tools will be used:

        -  Fugl-Meyer Motor Assessment Scale

        -  Box and Block Test

        -  Modified Ashworth Scale

        -  Visual Analogue Scale (VAS)

        -  Numerical Pain Rating Scale

        -  McGill Quality of Life

      At T0, T1, T2 and T3 some motion parameters will be recorded and monitored by the Leap Motion
      Controller to evaluate possible changes in the movements execution.

      Statistics:

      The Intention-To-Treat (ITT) population will be considered for the analysis. An unpaired
      Student's t test on the pre (T0)-post treatment (T2) differences will be used to assess the
      primary endpoint. Longitudinal trends over time will be assessed through repeated measures
      analysis of variance. Other analyses will be available in the statistical analysis plan.
    

Intervention name(s): STANDARD REHAB; SONICHAND
Intervention type(s): Other; Device
Intervention description(s): The rehabilitative standard intervention (Occupational Therapy) consists of 15 minutes of warm-up exercises plus a 20 minutes training with at least 6 exercises selected from:
wrist
ulnarization radialization
prono-supination
horizontal flexion-extension
vertical flexion-extension hand
grasping
pinching
extensors
interosseous shoulder-elbow
vertical flexion-extension
push forward; The intervention is similar to the standard protocol (15 minutes of warm-up plus 20 minute of training) but involves the sonification of the exercises selected from the list. The Leap Motion Controller is managed with an ad-hoc developed application that is able to associate the movements with a 4 notes arpeggio or with a modulated texture.
With the first mode the movement produces and modulates an harmonic progression built on the consecutive grades of the major scale played as ascending and descending arpeggio with also a volume crescendo and decrescendo.
With the second mode, the movement modulates the volume and the low-pass cutoff frequency of a synthetic texture.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Music therapy; Sonification technique; Rehabilitation