StrokeSONICHANDNCT03306797
Music Therapy for Rehabilitation in Stroke Patients
A study testing STANDARD REHAB and SONICHAND in people with Stroke and Hand Injuries, run by Istituti Clinici Scientifici Maugeri SpA at 4 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Stroke, Hand Injuries
- What is being tested?
- STANDARD REHAB and SONICHAND
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 4 sitesItaly
- Study dates
- 28 Mar 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
ICS Maugeri, Nervi Institute
Genoa, Genova
ICS Maugeri, Montescano Institute
Montescano, Pavia
ICS Maugeri, Pavia Institute
Pavia, 27100
Fondazione Santa Lucia IRCCS
Rome
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Hand Injuries
- Being tested
- STANDARD REHAB, SONICHAND
- Keywords
- Music therapy, Sonification technique, Rehabilitation
- Medical subject headings
- Stroke, Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STANDARD REHABOther
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
SONICHANDDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SONICHAND | Experimental | 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) Receives: Device: SONICHAND |
| STANDARD REHAB | Other | The rehabilitative standard intervention (Occupational Therapy) consists of 15 minutes of warm-up exercises plus a 20 minutes training for 4 weeks (daily) Receives: Other: STANDARD REHAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (5)
Box and Block Test (BBT)
Assessment of unilateral gross manual dexterity
Measured: up to 8 weeks
Modified Ashworth Scale
Measurement of spasticity
Measured: up to 8 weeks
Visual Analogue Scale (VAS)
Evaluation of perceived fatigue
Measured: up to 8 weeks
Numerical Pain Rating Scale (NPRS)
Assessment of pain intensity
Measured: up to 8 weeks
McGill Quality of Life
Assessment of Quality of Life
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start28 Mar 2017
- Primary completion15 May 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306797
- Sponsor's protocol ID
- 2088 CE
- Acronym
- SONICHAND
- Status last verified
- Apr 2021
- First submitted
- 4 Aug 2017
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Altenmuller E, Marco-Pallares J, Munte TF, Schneider S. Neural reorganization underlies improvement in stroke-induced motor dysfunction by music-supported therapy. Ann N Y Acad Sci. 2009 Jul;1169:395-405. doi: 10.1111/j.1749-6632.2009.04580.x.
PubMed 19673814Bangert M, Altenmuller EO. Mapping perception to action in piano practice: a longitudinal DC-EEG study. BMC Neurosci. 2003 Oct 15;4:26. doi: 10.1186/1471-2202-4-26.
PubMed 14575529Bangert M, Peschel T, Schlaug G, Rotte M, Drescher D, Hinrichs H, Heinze HJ, Altenmuller E. Shared networks for auditory and motor processing in professional pianists: evidence from fMRI conjunction. Neuroimage. 2006 Apr 15;30(3):917-26. doi: 10.1016/j.neuroimage.2005.10.044. Epub 2005 Dec 27.
PubMed 16380270Baumann S, Koeneke S, Schmidt CF, Meyer M, Lutz K, Jancke L. A network for audio-motor coordination in skilled pianists and non-musicians. Brain Res. 2007 Aug 3;1161:65-78. doi: 10.1016/j.brainres.2007.05.045. Epub 2007 Jun 4.
PubMed 17603027Cha Y, Kim Y, Hwang S, Chung Y. Intensive gait training with rhythmic auditory stimulation in individuals with chronic hemiparetic stroke: a pilot randomized controlled study. NeuroRehabilitation. 2014;35(4):681-8. doi: 10.3233/NRE-141182.
PubMed 25318784Chen P, Lai CKY, Chung RCK, Ng SSM. The Jacket Test for assessing people with chronic stroke. Disabil Rehabil. 2017 Dec;39(25):2577-2583. doi: 10.1080/09638288.2016.1236413. Epub 2016 Oct 28.
PubMed 27793076Chong HJ, Han SJ, Kim YJ, Park HY, Kim SJ. Relationship between output from MIDI-keyboard playing and hand function assessments on affected hand after stroke. NeuroRehabilitation. 2014;35(4):673-80. doi: 10.3233/NRE-141166.
PubMed 25318775Conklyn D, Novak E, Boissy A, Bethoux F, Chemali K. The effects of modified melodic intonation therapy on nonfluent aphasia: a pilot study. J Speech Lang Hear Res. 2012 Oct;55(5):1463-71. doi: 10.1044/1092-4388(2012/11-0105). Epub 2012 Mar 12.
PubMed 22411278Desrosiers J, Bravo G, Hebert R, Dutil E, Mercier L. Validation of the Box and Block Test as a measure of dexterity of elderly people: reliability, validity, and norms studies. Arch Phys Med Rehabil. 1994 Jul;75(7):751-5.
PubMed 8024419Hayden R, Clair AA, Johnson G, Otto D. The effect of rhythmic auditory stimulation (RAS) on physical therapy outcomes for patients in gait training following stroke: a feasibility study. Int J Neurosci. 2009;119(12):2183-95. doi: 10.3109/00207450903152609.
PubMed 19916847Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
PubMed 4139420Kim SJ, Koh I. The effects of music on pain perception of stroke patients during upper extremity joint exercises. J Music Ther. 2005 Spring;42(1):81-92. doi: 10.1093/jmt/42.1.81.
PubMed 15839735Kim DS, Park YG, Choi JH, Im SH, Jung KJ, Cha YA, Jung CO, Yoon YH. Effects of music therapy on mood in stroke patients. Yonsei Med J. 2011 Nov;52(6):977-81. doi: 10.3349/ymj.2011.52.6.977.
PubMed 22028163Kim SJ, Jo U. Study of accent-based music speech protocol development for improving voice problems in stroke patients with mixed dysarthria. NeuroRehabilitation. 2013;32(1):185-90. doi: 10.3233/NRE-130835.
PubMed 23422471Iosa M, Morone G, Fusco A, Castagnoli M, Fusco FR, Pratesi L, Paolucci S. Leap motion controlled videogame-based therapy for rehabilitation of elderly patients with subacute stroke: a feasibility pilot study. Top Stroke Rehabil. 2015 Aug;22(4):306-16. doi: 10.1179/1074935714Z.0000000036. Epub 2015 Feb 25.
PubMed 26258456
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Rehabilitation With Music Therapy Technique (Sonification) and Leap Motion Controller in Stroke Patients
- ClinicalTrials.gov ID
- NCT03306797
- Acronym / sponsor ID
- SONICHAND / 2088 CE
- Conditions
- Stroke, Hand Injuries
- Keywords
- Music therapy, Sonification technique, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SONICHAND | Experimental | Device: SONICHANDThe 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) |
| STANDARD REHAB | Other | Other: STANDARD REHABThe rehabilitative standard intervention (Occupational Therapy) consists of 15 minutes of warm-up exercises plus a 20 minutes training for 4 weeks (daily) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STANDARD REHABThe 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 | Other | STANDARD REHAB |
| SONICHANDThe 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. | Device | SONICHAND |
Primary outcome
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.
5 secondary outcomes
Box and Block Test (BBT)
Time frame: up to 8 weeks
Modified Ashworth Scale
Time frame: up to 8 weeks
Visual Analogue Scale (VAS)
Time frame: up to 8 weeks
Numerical Pain Rating Scale (NPRS)
Time frame: up to 8 weeks
McGill Quality of Life
Time frame: up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Background: PubMed 19673814Altenmuller E, Marco-Pallares J, Munte TF, Schneider S. Neural reorganization underlies improvement in stroke-induced motor dysfunction by music-supported therapy. Ann N Y Acad Sci. 2009 Jul;1169:395-405. doi: 10.1111/j.1749-6632.2009.04580.x.
- Background: PubMed 14575529Bangert M, Altenmuller EO. Mapping perception to action in piano practice: a longitudinal DC-EEG study. BMC Neurosci. 2003 Oct 15;4:26. doi: 10.1186/1471-2202-4-26.
- Background: PubMed 16380270Bangert M, Peschel T, Schlaug G, Rotte M, Drescher D, Hinrichs H, Heinze HJ, Altenmuller E. Shared networks for auditory and motor processing in professional pianists: evidence from fMRI conjunction. Neuroimage. 2006 Apr 15;30(3):917-26. doi: 10.1016/j.neuroimage.2005.10.044. Epub 2005 Dec 27.
- Background: PubMed 17603027Baumann S, Koeneke S, Schmidt CF, Meyer M, Lutz K, Jancke L. A network for audio-motor coordination in skilled pianists and non-musicians. Brain Res. 2007 Aug 3;1161:65-78. doi: 10.1016/j.brainres.2007.05.045. Epub 2007 Jun 4.
- Background: PubMed 25318784Cha Y, Kim Y, Hwang S, Chung Y. Intensive gait training with rhythmic auditory stimulation in individuals with chronic hemiparetic stroke: a pilot randomized controlled study. NeuroRehabilitation. 2014;35(4):681-8. doi: 10.3233/NRE-141182.
- Background: PubMed 27793076Chen P, Lai CKY, Chung RCK, Ng SSM. The Jacket Test for assessing people with chronic stroke. Disabil Rehabil. 2017 Dec;39(25):2577-2583. doi: 10.1080/09638288.2016.1236413. Epub 2016 Oct 28.
- Background: PubMed 25318775Chong HJ, Han SJ, Kim YJ, Park HY, Kim SJ. Relationship between output from MIDI-keyboard playing and hand function assessments on affected hand after stroke. NeuroRehabilitation. 2014;35(4):673-80. doi: 10.3233/NRE-141166.
- Background: PubMed 22411278Conklyn D, Novak E, Boissy A, Bethoux F, Chemali K. The effects of modified melodic intonation therapy on nonfluent aphasia: a pilot study. J Speech Lang Hear Res. 2012 Oct;55(5):1463-71. doi: 10.1044/1092-4388(2012/11-0105). Epub 2012 Mar 12.
- Background: PubMed 8024419Desrosiers J, Bravo G, Hebert R, Dutil E, Mercier L. Validation of the Box and Block Test as a measure of dexterity of elderly people: reliability, validity, and norms studies. Arch Phys Med Rehabil. 1994 Jul;75(7):751-5.
- Background: PubMed 19916847Hayden R, Clair AA, Johnson G, Otto D. The effect of rhythmic auditory stimulation (RAS) on physical therapy outcomes for patients in gait training following stroke: a feasibility study. Int J Neurosci. 2009;119(12):2183-95. doi: 10.3109/00207450903152609.
- Background: PubMed 4139420Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
- Background: PubMed 15839735Kim SJ, Koh I. The effects of music on pain perception of stroke patients during upper extremity joint exercises. J Music Ther. 2005 Spring;42(1):81-92. doi: 10.1093/jmt/42.1.81.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STANDARD REHAB and SONICHAND in people with Stroke and Hand Injuries, run by Istituti Clinici Scientifici Maugeri SpA at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Motor Assessment Scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03306797, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.