Clinical trial NCT03306797: Music Therapy for Rehabilitation in Stroke Patients
Official title: Hand Rehabilitation With Music Therapy Technique (Sonification) and Leap Motion Controller in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hand Injuries
Keywords: Music therapy
Sonification technique
Rehabilitation
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 65
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fugl-Meyer Motor Assessment Scale
timeFrame: 4 weeks
Secondary outcomes:
measure: Box and Block Test (BBT)
timeFrame: up to 8 weeks
measure: Modified Ashworth Scale
timeFrame: up to 8 weeks
measure: Visual Analogue Scale (VAS)
timeFrame: up to 8 weeks
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: up to 8 weeks
measure: McGill Quality of Life
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: ICS Maugeri, Nervi Institute
state: Genova
city: Montescano
country: Italy
facility: ICS Maugeri, Montescano Institute
state: Pavia
city: Pavia
country: Italy
facility: ICS Maugeri, Pavia Institute
city: Rome
country: Italy
facility: Fondazione Santa Lucia IRCCS
Study officials:
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