Music Therapy for Rehabilitation in Stroke Patients

Stroke Clinical Trial

— SONICHAND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03306797
• Other study ID #: 2088 CE
• Status: Completed
• Phase: N/A
• Start date: March 28, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2021
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 31, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hand Injuries
• Stroke

Intervention

Other:
• STANDARD REHAB
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

Device:
• SONICHAND
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.

Locations

Country	Name	City	State
Italy	ICS Maugeri, Nervi Institute	Genoa	Genova
Italy	ICS Maugeri, Montescano Institute	Montescano	Pavia
Italy	ICS Maugeri, Pavia Institute	Pavia
Italy	Fondazione Santa Lucia IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA

Country where clinical trial is conducted

Italy, 

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

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