Music Therapy for Rehabilitation in Stroke Patients

NCT03306797 | Completed

• 1 other identifier: 2088 CE
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 4

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.

Conditions

Stroke; Hand Injuries

Keywords

Music therapy; Sonification technique; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Box and Block Test (BBT)

  up to 8 weeks

• Modified Ashworth Scale

  up to 8 weeks

• Visual Analogue Scale (VAS)

  up to 8 weeks

• Numerical Pain Rating Scale (NPRS)

  up to 8 weeks

• McGill Quality of Life

  up to 8 weeks

Study Arms (2)

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)

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)

Other: STANDARD REHAB

Interventions

STANDARD REHAB OTHER

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

STANDARD REHAB

SONICHAND DEVICE

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.

SONICHAND

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (4)

ICS Maugeri, Nervi Institute

Genoa, Genova, Italy

Location

ICS Maugeri, Montescano Institute

Montescano, Pavia, Italy

Location

ICS Maugeri, Pavia Institute

Pavia, 27100, Italy

Location

Fondazione Santa Lucia IRCCS

Rome, Italy

Location

Related Publications (40)

• 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.

  PMID: 19673814 BACKGROUND

• Bangert 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.

  PMID: 14575529 BACKGROUND

• Bangert 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.

  PMID: 16380270 BACKGROUND

• Baumann 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.

  PMID: 17603027 BACKGROUND

• Cha 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.

  PMID: 25318784 BACKGROUND

• Chen 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.

  PMID: 27793076 BACKGROUND

• Chong 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.

  PMID: 25318775 BACKGROUND

• Conklyn 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.

  PMID: 22411278 BACKGROUND

• Desrosiers 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.

  PMID: 8024419 BACKGROUND

• Hayden 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.

  PMID: 19916847 BACKGROUND

• Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.

  PMID: 4139420 BACKGROUND

• Kim 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.

  PMID: 15839735 BACKGROUND

• Kim 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.

  PMID: 22028163 BACKGROUND

• Kim 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.

  PMID: 23422471 BACKGROUND

• Iosa 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.

  PMID: 26258456 BACKGROUND

• Jun EM, Roh YH, Kim MJ. The effect of music-movement therapy on physical and psychological states of stroke patients. J Clin Nurs. 2013 Jan;22(1-2):22-31. doi: 10.1111/j.1365-2702.2012.04243.x. Epub 2012 Sep 17.

  PMID: 22978325 BACKGROUND

• Gregson JM, Leathley MJ, Moore AP, Smith TL, Sharma AK, Watkins CL. Reliability of measurements of muscle tone and muscle power in stroke patients. Age Ageing. 2000 May;29(3):223-8. doi: 10.1093/ageing/29.3.223.

  PMID: 10855904 BACKGROUND

• Lim KB, Kim YK, Lee HJ, Yoo J, Hwang JY, Kim JA, Kim SK. The therapeutic effect of neurologic music therapy and speech language therapy in post-stroke aphasic patients. Ann Rehabil Med. 2013 Aug;37(4):556-62. doi: 10.5535/arm.2013.37.4.556. Epub 2013 Aug 26.

  PMID: 24020037 BACKGROUND

• Magee WL, Davidson JW. The effect of music therapy on mood states in neurological patients: a pilot study. J Music Ther. 2002 Spring;39(1):20-9. doi: 10.1093/jmt/39.1.20.

  PMID: 12015809 BACKGROUND

• Meyer M, Elmer S, Baumann S, Jancke L. Short-term plasticity in the auditory system: differential neural responses to perception and imagery of speech and music. Restor Neurol Neurosci. 2007;25(3-4):411-31.

  PMID: 17943016 BACKGROUND

• Purdie H, Hamilton S, Baldwin S. Music therapy: facilitating behavioural and psychological change in people with stroke--a pilot study. Int J Rehabil Res. 1997 Sep;20(3):325-7. No abstract available.

  PMID: 9331582 BACKGROUND

• Sarkamo T, Tervaniemi M, Laitinen S, Forsblom A, Soinila S, Mikkonen M, Autti T, Silvennoinen HM, Erkkila J, Laine M, Peretz I, Hietanen M. Music listening enhances cognitive recovery and mood after middle cerebral artery stroke. Brain. 2008 Mar;131(Pt 3):866-76. doi: 10.1093/brain/awn013.

  PMID: 18287122 BACKGROUND

• Sarkamo T, Pihko E, Laitinen S, Forsblom A, Soinila S, Mikkonen M, Autti T, Silvennoinen HM, Erkkila J, Laine M, Peretz I, Hietanen M, Tervaniemi M. Music and speech listening enhance the recovery of early sensory processing after stroke. J Cogn Neurosci. 2010 Dec;22(12):2716-27. doi: 10.1162/jocn.2009.21376.

  PMID: 19925203 BACKGROUND

• Schlaug G. Part VI introduction: listening to and making music facilitates brain recovery processes. Ann N Y Acad Sci. 2009 Jul;1169:372-3. doi: 10.1111/j.1749-6632.2009.04869.x. No abstract available.

  PMID: 19673811 BACKGROUND

• Schneider S, Schonle PW, Altenmuller E, Munte TF. Using musical instruments to improve motor skill recovery following a stroke. J Neurol. 2007 Oct;254(10):1339-46. doi: 10.1007/s00415-006-0523-2. Epub 2007 Jan 27.

  PMID: 17260171 BACKGROUND

• Scholz DS, Rohde S, Nikmaram N, Bruckner HP, Grossbach M, Rollnik JD, Altenmuller EO. Sonification of Arm Movements in Stroke Rehabilitation - A Novel Approach in Neurologic Music Therapy. Front Neurol. 2016 Jun 30;7:106. doi: 10.3389/fneur.2016.00106. eCollection 2016.

  PMID: 27445970 BACKGROUND

• Scholz DS, Rhode S, Grossbach M, Rollnik J, Altenmuller E. Moving with music for stroke rehabilitation: a sonification feasibility study. Ann N Y Acad Sci. 2015 Mar;1337:69-76. doi: 10.1111/nyas.12691.

  PMID: 25773619 BACKGROUND

• Scholz DS, Wu L, Pirzer J, Schneider J, Rollnik JD, Grossbach M, Altenmuller EO. Sonification as a possible stroke rehabilitation strategy. Front Neurosci. 2014 Oct 20;8:332. doi: 10.3389/fnins.2014.00332. eCollection 2014.

  PMID: 25368548 BACKGROUND

• Sguazzin C, Giorgi I, Alesii A, Fini M. Italian validation of the McGill Quality of Life Questionnaire (MQOL-It). G Ital Med Lav Ergon. 2010 Jul-Sep;32(3 Suppl B):B58-62.

  PMID: 21299077 BACKGROUND

• Smeragliuolo AH, Hill NJ, Disla L, Putrino D. Validation of the Leap Motion Controller using markered motion capture technology. J Biomech. 2016 Jun 14;49(9):1742-1750. doi: 10.1016/j.jbiomech.2016.04.006. Epub 2016 Apr 8.

  PMID: 27102160 BACKGROUND

• Suh JH, Han SJ, Jeon SY, Kim HJ, Lee JE, Yoon TS, Chong HJ. Effect of rhythmic auditory stimulation on gait and balance in hemiplegic stroke patients. NeuroRehabilitation. 2014;34(1):193-9. doi: 10.3233/NRE-131008.

  PMID: 24284453 BACKGROUND

• Tamplin J, Baker FA, Jones B, Way A, Lee S. 'Stroke a Chord': the effect of singing in a community choir on mood and social engagement for people living with aphasia following a stroke. NeuroRehabilitation. 2013;32(4):929-41. doi: 10.3233/NRE-130916.

  PMID: 23867418 BACKGROUND

• Thaut MH, McIntosh GC, Rice RR. Rhythmic facilitation of gait training in hemiparetic stroke rehabilitation. J Neurol Sci. 1997 Oct 22;151(2):207-12. doi: 10.1016/s0022-510x(97)00146-9.

  PMID: 9349677 BACKGROUND

• Thaut MH, Leins AK, Rice RR, Argstatter H, Kenyon GP, McIntosh GC, Bolay HV, Fetter M. Rhythmic auditory stimulation improves gait more than NDT/Bobath training in near-ambulatory patients early poststroke: a single-blind, randomized trial. Neurorehabil Neural Repair. 2007 Sep-Oct;21(5):455-9. doi: 10.1177/1545968307300523. Epub 2007 Apr 10.

  PMID: 17426347 BACKGROUND

• Tung JY, Lulic T, Gonzalez DA, Tran J, Dickerson CR, Roy EA. Evaluation of a portable markerless finger position capture device: accuracy of the Leap Motion controller in healthy adults. Physiol Meas. 2015 May;36(5):1025-35. doi: 10.1088/0967-3334/36/5/1025. Epub 2015 Apr 22.

  PMID: 25902961 BACKGROUND

• van Delden AL, Peper CL, Nienhuys KN, Zijp NI, Beek PJ, Kwakkel G. Unilateral versus bilateral upper limb training after stroke: the Upper Limb Training After Stroke clinical trial. Stroke. 2013 Sep;44(9):2613-6. doi: 10.1161/STROKEAHA.113.001969. Epub 2013 Jul 18.

  PMID: 23868279 BACKGROUND

• van Wijck F, Knox D, Dodds C, Cassidy G, Alexander G, MacDonald R. Making music after stroke: using musical activities to enhance arm function. Ann N Y Acad Sci. 2012 Apr;1252:305-11. doi: 10.1111/j.1749-6632.2011.06403.x.

  PMID: 22524372 BACKGROUND

• Villeneuve M, Penhune V, Lamontagne A. A piano training program to improve manual dexterity and upper extremity function in chronic stroke survivors. Front Hum Neurosci. 2014 Aug 22;8:662. doi: 10.3389/fnhum.2014.00662. eCollection 2014.

  PMID: 25202258 BACKGROUND

• Weichert F, Bachmann D, Rudak B, Fisseler D. Analysis of the accuracy and robustness of the leap motion controller. Sensors (Basel). 2013 May 14;13(5):6380-93. doi: 10.3390/s130506380.

  PMID: 23673678 BACKGROUND

• Wittwer JE, Webster KE, Hill K. Rhythmic auditory cueing to improve walking in patients with neurological conditions other than Parkinson's disease--what is the evidence? Disabil Rehabil. 2013 Jan;35(2):164-76. doi: 10.3109/09638288.2012.690495. Epub 2012 Jun 8.

  PMID: 22681598 BACKGROUND

MeSH Terms

Conditions

Stroke; Hand Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: October 11, 2017
• Study Start: March 28, 2017
• Primary Completion: May 15, 2019
• Study Completion: December 31, 2019
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)