NCT02925065

Brief Summary

This controlled prospective cohort study is designed to assess the feasibility and effect of twice-weekly 60 minute non-traditional guitar classes on PD patient's self-reported and measurable outcomes including upper extremity function, motor findings, quality of life, mood, and cognitive findings. 24-30 individuals with PD will be randomly assigned to an early-start and a late-start guitar instruction group. Prior to conducting a larger study, this study seeks to assess the possibility that participation in an instrumental performance activity in a group setting may improve outcomes in PD patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
1.4 years until next milestone

Study Start

First participant enrolled

March 5, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2018

Completed
Last Updated

October 2, 2018

Status Verified

September 1, 2018

Enrollment Period

3 months

First QC Date

October 4, 2016

Last Update Submit

September 28, 2018

Conditions

Keywords

Parkinson'sNon-traditional guitar instructionGuitar therapyUpper extremity motor functionHand dexterity

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    Percentage of study completion will be used to assess feasibility of the intervention along with descriptive statistics. The study will be deemed feasible if 80% of participants complete 10 or more guitar group interventions. The factors that affect probability of attending guitar classes will also be investigated.

    6 weeks

Secondary Outcomes (10)

  • Efficacy: Quality of Life

    6 weeks and 12 week follow up

  • Upper extremity motor function

    6 weeks and 12 weeks follow up

  • Fine manual dexterity

    6 weeks and 12 weeks follow up

  • Gross manual dexterity

    6 weeks and 12 weeks follow up

  • Upper extremity activities of daily living function

    6 weeks and 12 weeks follow up

  • +5 more secondary outcomes

Study Arms (2)

Early-start guitar instruction group

EXPERIMENTAL

A 6 week twice-weekly non-traditional group guitar instruction will be implemented in addition to usual treatment between weeks 1-6 of the study.

Other: Non-traditional group guitar instruction

Delayed-start guitar instruction group

EXPERIMENTAL

A 6 week twice-weekly non-traditional group guitar instruction will be implemented in addition to usual treatment between weeks 8-13 of the study.

Other: Non-traditional group guitar instruction

Interventions

A 6-week curriculum for non-traditional training in finger-style guitar has been developed with rhythmic and goal oriented upper extremity and finger movements. Guitar group intervention will be implemented at the Towson campus of the Peabody Preparatory. Intervention approaches will include rhythmic digital grip with finger isolation, goal directed rhythmic reach on the fret-board and rhythmic alternating tap-like digit and hand movements on the guitar. Participants will be provided with the instruments in the group setting without expectation of practice at home.

Delayed-start guitar instruction groupEarly-start guitar instruction group

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (age 18-89) with idiopathic PD diagnosis according to the United Kingdom (UK) Brain Bank Criteria with bilateral motor symptoms.
  • Hoehn and Yahr Stages 1-3.
  • MoCA score \>24 to screen out patients with dementia.

You may not qualify if:

  • Prior exposure to guitar training.
  • History of prior trauma of the brain or upper extremities.
  • Inability to personally consent to study.
  • Inability or unwillingness to participate in twice weekly classes for 6 weeks.
  • Agitation or hallucinations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University (Peabody Institute & Department of Neurology)

Baltimore, Maryland, 21202, United States

Location

Related Publications (23)

  • 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: 19673814BACKGROUND
  • Austin D, Jimison H, Hayes T, Mattek N, Kaye J, Pavel M. Measuring motor speed through typing: a surrogate for the finger tapping test. Behav Res Methods. 2011 Dec;43(4):903-9. doi: 10.3758/s13428-011-0100-1.

    PMID: 21494919BACKGROUND
  • Benoit CE, Dalla Bella S, Farrugia N, Obrig H, Mainka S, Kotz SA. Musically cued gait-training improves both perceptual and motor timing in Parkinson's disease. Front Hum Neurosci. 2014 Jul 7;8:494. doi: 10.3389/fnhum.2014.00494. eCollection 2014.

    PMID: 25071522BACKGROUND
  • Bloem BR, de Vries NM, Ebersbach G. Nonpharmacological treatments for patients with Parkinson's disease. Mov Disord. 2015 Sep 15;30(11):1504-20. doi: 10.1002/mds.26363. Epub 2015 Aug 14.

    PMID: 26274930BACKGROUND
  • de Dreu MJ, van der Wilk AS, Poppe E, Kwakkel G, van Wegen EE. Rehabilitation, exercise therapy and music in patients with Parkinson's disease: a meta-analysis of the effects of music-based movement therapy on walking ability, balance and quality of life. Parkinsonism Relat Disord. 2012 Jan;18 Suppl 1:S114-9. doi: 10.1016/S1353-8020(11)70036-0.

    PMID: 22166406BACKGROUND
  • Dorsey ER, George BP, Leff B, Willis AW. The coming crisis: obtaining care for the growing burden of neurodegenerative conditions. Neurology. 2013 May 21;80(21):1989-96. doi: 10.1212/WNL.0b013e318293e2ce. Epub 2013 Apr 24.

    PMID: 23616157BACKGROUND
  • Francois C, Grau-Sanchez J, Duarte E, Rodriguez-Fornells A. Musical training as an alternative and effective method for neuro-education and neuro-rehabilitation. Front Psychol. 2015 Apr 28;6:475. doi: 10.3389/fpsyg.2015.00475. eCollection 2015.

    PMID: 25972820BACKGROUND
  • Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.

    PMID: 19025984BACKGROUND
  • Grau-Sanchez J, Amengual JL, Rojo N, Veciana de Las Heras M, Montero J, Rubio F, Altenmuller E, Munte TF, Rodriguez-Fornells A. Plasticity in the sensorimotor cortex induced by Music-supported therapy in stroke patients: a TMS study. Front Hum Neurosci. 2013 Sep 3;7:494. doi: 10.3389/fnhum.2013.00494. eCollection 2013.

    PMID: 24027507BACKGROUND
  • Gummesson C, Ward MM, Atroshi I. The shortened disabilities of the arm, shoulder and hand questionnaire (QuickDASH): validity and reliability based on responses within the full-length DASH. BMC Musculoskelet Disord. 2006 May 18;7:44. doi: 10.1186/1471-2474-7-44.

    PMID: 16709254BACKGROUND
  • Hughes AJ, Daniel SE, Kilford L, Lees AJ. Accuracy of clinical diagnosis of idiopathic Parkinson's disease: a clinico-pathological study of 100 cases. J Neurol Neurosurg Psychiatry. 1992 Mar;55(3):181-4. doi: 10.1136/jnnp.55.3.181.

    PMID: 1564476BACKGROUND
  • Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

    PMID: 15817019BACKGROUND
  • Peto V, Jenkinson C, Fitzpatrick R. PDQ-39: a review of the development, validation and application of a Parkinson's disease quality of life questionnaire and its associated measures. J Neurol. 1998 May;245 Suppl 1:S10-4. doi: 10.1007/pl00007730.

    PMID: 9617716BACKGROUND
  • Pohl P, Dizdar N, Hallert E. The Ronnie Gardiner Rhythm and Music Method - a feasibility study in Parkinson's disease. Disabil Rehabil. 2013;35(26):2197-204. doi: 10.3109/09638288.2013.774060. Epub 2013 Mar 12.

    PMID: 23480646BACKGROUND
  • Proud EL, Miller KJ, Bilney B, Balachandran S, McGinley JL, Morris ME. Evaluation of measures of upper limb functioning and disability in people with Parkinson disease: a systematic review. Arch Phys Med Rehabil. 2015 Mar;96(3):540-551.e1. doi: 10.1016/j.apmr.2014.09.016. Epub 2014 Oct 7.

    PMID: 25301441BACKGROUND
  • Pringsheim T, Jette N, Frolkis A, Steeves TD. The prevalence of Parkinson's disease: a systematic review and meta-analysis. Mov Disord. 2014 Nov;29(13):1583-90. doi: 10.1002/mds.25945. Epub 2014 Jun 28.

    PMID: 24976103BACKGROUND
  • Raglio A. Music Therapy Interventions in Parkinson's Disease: The State-of-the-Art. Front Neurol. 2015 Aug 31;6:185. doi: 10.3389/fneur.2015.00185. eCollection 2015. No abstract available.

    PMID: 26379619BACKGROUND
  • Rochester L, Baker K, Hetherington V, Jones D, Willems AM, Kwakkel G, Van Wegen E, Lim I, Nieuwboer A. Evidence for motor learning in Parkinson's disease: acquisition, automaticity and retention of cued gait performance after training with external rhythmical cues. Brain Res. 2010 Mar 10;1319:103-11. doi: 10.1016/j.brainres.2010.01.001. Epub 2010 Jan 11.

    PMID: 20064492BACKGROUND
  • 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: 17260171BACKGROUND
  • Van Vugt FT, Ritter J, Rollnik JD, Altenmuller E. Music-supported motor training after stroke reveals no superiority of synchronization in group therapy. Front Hum Neurosci. 2014 May 20;8:315. doi: 10.3389/fnhum.2014.00315. eCollection 2014.

    PMID: 24904358BACKGROUND
  • Hartigan, B. J., & Sarrafian, S. K. (2004). Kinesiology and functional characteristics of upper limb. In D. G. Smith, J. W. Michael, & J. H. Bowker (Eds.), Atlas of amputations and limb deficiencies: surgical, prosthetic, and rehabilitation principles (3rd Edition ed., pp. 101-116). Rosemont, IL: American Academy of Orthopaedic Surgeons.

    BACKGROUND
  • Sheikh J.I., & Yesavage J.A. (1986): Geriatric Depression Scale (GDS): Recent evidence and development of a shorter version. In: Brink TL, editor. Clinical Gerontology: A Guide to Assessment and Intervention. Binghampton,NY: The Haworth Press. 165-173.

    BACKGROUND
  • Richard K Miller and Associates. (2012). The 2012-2013 Leisure Market Research Handbook. Loganville, GA: Richard K. Miller and Associates.

    BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Serap E Bastepe-Gray, MD, MM, MsOT

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
  • Alexander Pantelyat, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to early-start or late start guitar groups. Following baseline assessment week, the early-start group will receive twice-weekly non traditional guitar instruction for 6 weeks. The late-start guitar group will receive same intervention after the early-start group complete their 6 week instruction. Study assessments will be conducted during week 7 and week 14. Follow up assessment will be conducted in week 20.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 5, 2016

Study Start

March 5, 2018

Primary Completion

June 7, 2018

Study Completion

July 26, 2018

Last Updated

October 2, 2018

Record last verified: 2018-09

Locations