Music Therapy for Rehabilitation in Stroke Patients (SONICHAND)

April 26, 2021 updated by: Istituti Clinici Scientifici Maugeri SpA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • ICS Maugeri, Pavia Institute
      • Rome, Italy
        • Fondazione Santa Lucia IRCCS
    • Genova
      • Genoa, Genova, Italy
        • ICS Maugeri, Nervi Institute
    • Pavia
      • Montescano, Pavia, Italy
        • ICS Maugeri, Montescano Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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 (4 weeks, daily)
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.
Other: STANDARD REHAB
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Motor Assessment Scale
Time Frame: 4 weeks
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)
Time Frame: up to 8 weeks
Assessment of unilateral gross manual dexterity
up to 8 weeks
Modified Ashworth Scale
Time Frame: up to 8 weeks
Measurement of spasticity
up to 8 weeks
Visual Analogue Scale (VAS)
Time Frame: up to 8 weeks
Evaluation of perceived fatigue
up to 8 weeks
Numerical Pain Rating Scale (NPRS)
Time Frame: up to 8 weeks
Assessment of pain intensity
up to 8 weeks
McGill Quality of Life
Time Frame: up to 8 weeks
Assessment of Quality of Life
up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2017

Primary Completion (Actual)

May 15, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

August 4, 2017

First Submitted That Met QC Criteria

October 5, 2017

First Posted (Actual)

October 11, 2017

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2088 CE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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