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Parkinson's DiseasePD/GuitarNCT02925065

Impact of Non-traditional Guitar Group Instruction on Functional Movement and Well-being in Parkinson's Disease Patients

A study testing Non-traditional group guitar instruction in people with Parkinson's Disease, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Non-traditional group guitar instruction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
5 Mar 2018to 26 Jul 2018
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 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Johns Hopkins University (Peabody Institute & Department of Neurology)

    Baltimore, Maryland, 21202

Other trials in United States

About this study

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.

Read the detailed description

PROBLEM STATEMENT: Engagement in musical activities has been found to improve symptoms in individuals with Parkinson's disease (PD), and physical therapy and music therapy have been demonstrated as viable non-pharmacological intervention methods that improve motor function in these individuals. Therapeutic instrumental music performance has the attributes of physical, rhythmic and social engagement combined with immediate auditory feedback, and has the potential to bring in additional neuro-rehabilitative effects associated with musical engagement into a treatment design. However, until now, much of the research has focused on the rhythmic aspects of music. Few studies have examined how active and complex engagement with music, such as learning to play an instrument, may help PD patients. Finger-style guitar instruction has the potential to improve bilateral dexterity in addition to other gains reported with music-based interventions in patients with PD.

PURPOSE: The purpose of this pilot controlled prospective cohort study is to assess the feasibility and the effects of non-traditional finger-style guitar classes on the quality of life, motor symptoms, upper extremity function, cognition, mood and social participation in individuals with PD.

HYPOTHESIS: The investigators hypothesize that a 6-week bi-weekly finger-style guitar group intervention (12 sessions in total) in addition to usual and routine treatment will be a feasible intervention in patients with Parkinson's Disease (PD), and both immediate and delayed start groups, of PD patients who participate in a twice-weekly non-traditional guitar class training for 6 weeks will have unchanged or improved upper extremity function and dexterity, improved quality of life and mood.

IMPORTANCE: The estimated overall prevalence of PD in the world is 315 per 100,000 individuals overall, and about 2 per 100 individuals 60 years of age or older, with higher estimates for older individuals living in North America, Europe and Australia. PD prevalence in the United States is projected to rise by 77% between 2010 and 2030. Music and rhythm-based interventions are noninvasive, patient-oriented techniques that lack side effects. The guitar is the most popular played instrument in the U.S, and it is the principal instrument of choice for music therapists. It is affordable and portable, with easy access to commercial instruction. Non-traditional engagement in finger-style music making on the guitar may have a broad impact on PD by improving the quality of functional upper extremity movements, decreasing the amplitude of involuntary movements, increasing social and cognitive participation in activities of daily living, and improving quality of life.

Being tested
Non-traditional group guitar instruction
Keywords
Parkinson's, Non-traditional guitar instruction, Guitar therapy, Upper extremity motor function, Hand dexterity
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-traditional group guitar instructionOther

    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.

Study groups in NCT02925065
Study groupRoleWhat they receive
Early-start guitar instruction groupExperimentalA 6 week twice-weekly non-traditional group guitar instruction will be implemented in addition to usual treatment between weeks 1-6 of the study.
Receives: Other: Non-traditional group guitar instruction
Delayed-start guitar instruction groupExperimentalA 6 week twice-weekly non-traditional group guitar instruction will be implemented in addition to usual treatment between weeks 8-13 of the study.
Receives: Other: Non-traditional group guitar instruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 weeks

Secondary outcomes (10)
  1. Efficacy: Quality of Life

    The Parkinson disease quality of life assessment (PDQ-39) (Peto, Jenkinson \& Fitzpatrick, 1998) is a questionnaire that is designed to assess PD specific health related quality of life within the last month in individuals with PD. Dimensions covered include mobility, activities of daily living, emotional well-being, stigma and social support, cognition, communication and bodily support.

    Measured: 6 weeks and 12 week follow up

  2. Upper extremity motor function

    Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    Measured: 6 weeks and 12 weeks follow up

  3. Fine manual dexterity

    Purdue pegboard test (PPBT) involves timed assembly of small items and assesses fine manual dexterity.

    Measured: 6 weeks and 12 weeks follow up

  4. Gross manual dexterity

    Box and block test (BBT) involves timed transfer of 2.5cm3 blocks from one container to another and assesses the gross manual dexterity.

    Measured: 6 weeks and 12 weeks follow up

  5. Upper extremity activities of daily living function

    Quick-Disability of Arm, Shoulder and Hand (Q-DASH) (Gummeson, Ward \& Atroshi, 2006) is an 11-item questionnaire that measures the self-reported disability of upper extremity.

    Measured: 6 weeks and 12 weeks follow up

  6. Upper extremity finger typing accuracy and speed

    Finger typing task: Using index and middle finger to press 2 adjacent standard keyboard keys ('n' and 'm' for the right hand; 'c' and 'v' for the left hand) in alternating fashion as rapidly and accurately as possible in 60 seconds (each hand tested separately).

    Measured: 6 weeks and 12 weeks follow up

  7. Cognition

    Montreal Cognitive Assessment (MoCA) (Nasreddine, 2005) is a rapid cognitive screening test that assesses cognitive performance in multiple domains including visuo-spatial and executive functions, naming, memory, attention, language, abstraction, and orientation.

    Measured: 6 weeks and 12 week follow up

  8. Mood

    Geriatric Depression Scale (GD S-15) (Sheikh \& Yesavage, 1986) is a 15 item questionnaire that assesses depression and suicide ideation in elderly individuals.

    Measured: 6 weeks and 12 week follow up

  9. Social Participation

    World Health Organization Disability Assessment Schedule (WHODAS 2.0) Social participation subscale. WHODAS 2.0 is a 36 item disability assessment questionnaire developed by the WHO Classification, Terminology and Standards team to measure health and disability. The social participation subscale (Domain 6) contains 8 items and measures impact of health on social participation.

    Measured: 6 weeks and 12 weeks follow up

  10. Group participation

    Pittsburg Rehabilitation Participation Scale (PRPS) will be used to monitor participation intensity and quality of the participants in the guitar group intervention.

    Measured: 6 weeks and 12 weeks follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2016 (estimated)
  2. Study start5 Mar 2018
  3. Primary completion7 Jun 2018
  4. Study completion26 Jul 2018

Resources

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
Model description
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.
Masking
Single blind
Who is masked
Investigator
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02925065
Sponsor's protocol ID
IRB00091797
Acronym
PD/Guitar
Status last verified
Sep 2018
First submitted
4 Oct 2016
Last updated
2 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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 19673814
  • 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.

    PubMed 21494919
  • 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.

    PubMed 25071522
  • 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.

    PubMed 26274930
  • 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.

    PubMed 22166406
  • 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.

    PubMed 23616157
  • 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.

    PubMed 25972820
  • 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.

    PubMed 19025984
  • 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.

    PubMed 24027507
  • 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.

    PubMed 16709254
  • 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.

    PubMed 1564476
  • 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.

    PubMed 15817019
  • 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.

    PubMed 9617716
  • 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.

    PubMed 23480646
  • 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.

    PubMed 25301441

Questions about this trial

What is this clinical trial studying?

A study testing Non-traditional group guitar instruction in people with Parkinson's Disease, run by Johns Hopkins University at 1 site in United States.

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 5 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 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Feasibility (time frame: 6 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 NCT02925065, which also lists 23 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 2 Oct 2018.

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