Music Therapy for Rehabilitation in Stroke Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hand Rehabilitation With Music Therapy Technique (Sonification) and Leap Motion Controller in Stroke Patients

Conditions
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Stroke, Hand Injuries

Intervention / Treatment
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* Other: STANDARD REHAB
* Device: SONICHAND


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 40-85 years old ischemic lesion in one hemisphere (hemiplegia / hemiparesis right or left) Mini Mental State Examination > 24 onset acute event not later than 180 days prior to study entry Exclusion Criteria: Dated lesions beyond 6 months from onset Multiple or bilateral lesions Mini Mental State Examination <24 Presence of neglect Previous or concomitant disabling diseases for upper limb function (Eg: Parkinson's disease, multiple sclerosis, shoulder's periarthritis, Dupuytren's disease, etc.) Previous rehabilitative treatments with music

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SONICHAND<br>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 (4 weeks, daily) | Device: SONICHAND<br>* 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.<br>|
| Other: STANDARD REHAB<br>The rehabilitative standard intervention (Occupational Therapy) consists of 15 minutes of warm-up exercises plus a 20 minutes training for 4 weeks (daily) | Other: STANDARD REHAB<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Motor Assessment Scale | Primary endpoint of the study is given by the measurement of proximal and distal upper limb motor skills assessed by the Fugl-Meyer Motor Assessment Scale. The primary endpoint will be assessed by comparing the variation between T0 and T2 of the scale scores above mentioned in the experimental and control groups. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Box and Block Test (BBT) | Assessment of unilateral gross manual dexterity | up to 8 weeks | 
| Modified Ashworth Scale | Measurement of spasticity | up to 8 weeks | 
| Visual Analogue Scale (VAS) | Evaluation of perceived fatigue | up to 8 weeks | 
| Numerical Pain Rating Scale (NPRS) | Assessment of pain intensity | up to 8 weeks | 
| McGill Quality of Life | Assessment of Quality of Life | up to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Music therapy, Sonification technique, Rehabilitation