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van CCT (UK)

van CCT (UK)

The effects of music therapy on improving quality of life in Huntington's Disease patients

- candidate number20923
- NTR NumberNTR4904
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-nov-2014
- Secondary IDsP 14.038 METC, LUMC Leiden
- Public TitleThe effects of music therapy on improving quality of life in Huntington's Disease patients
- Scientific TitleThe effects of music therapy on improving quality of life in Huntington's Disease patients
- hypothesisHuntingtonís Disease (HD) is a progressive, neurodegenerative, autosomal dominant disease characterized by motor - and psychiatric disturbances, and cognitive decline. These changes often result in decline of the expressive and communicative skills, especially in the advanced stage of the disease. In practice this loss of communication results in behavior problems. Improving these skills might lead to change in behavior problems and a better quality of life. Music therapy may be a good non-pharmaceutical intervention to improve the communicative skills.
- Healt Condition(s) or Problem(s) studiedHuntington's disease
- Inclusion criteria-Age older than 18 years
-Clinically and genetically confirmed -Huntington's Disease (CAG > 36 repeats)
-Total Functional Capacity (TFC) of ≤ 7
- Exclusion criteria- Patients who suffer from other neurological disorders
- Patients with poor comprehension of the Dutch language
- patients who have received music therapy in the past 3 months
- patients with a hearing impairment
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 25-jun-2014
- planned closingdate1-jun-2016
- Target number of participants60
- InterventionsTwo random groups will be created.The experimental group (n = 30) will be offered a music therapy program, and the control group (n = 30) will participate in regular recreational day activities and will be offered under the exact same circumstances as the music therapy sessions. Participants from both the experimental and the control group are not allowed to receive (regular) music therapy outside the study. A total of 16 sessions once a week will be offered to both groups.
- Primary outcomeThe primary outcome measure is the Behaviour Observation Scale Huntington (BOSH).
- Secondary outcomeThe secondary outcome measure is the Problem Behaviours Assesment-short version (PBA-s).
- TimepointsAssessments will take place within a week before the first intervention (baseline assessment), and will be repeated within a week after the 8th and again within a week after the 16th intervention. A follow up assessment wil take place 12 weeks after the last session (week 28).
- Trial web site
- statusplanned
- CONTACT for SCIENTIFIC QUERIES M. Bruggen, van - Rufi
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Jacques & Gloria Gossweiler Foundation
- PublicationsAccepted (publication date January 2015):
"The effect of music therapy for patients with Huntington's disease: A systematic literature review"
In: Journal of Literature and Art Studies, Vol.5 - 1
- Brief summaryA single-blind randomized controlled intervention trial (RCT) is proposed to test the propositions and hypotheses. Sixty (60) Patients will be randomised using centre-stratified block-permuted randomization. Patients will be allocated to the music therapy group or the control group. Both groups will receive 16 treatments. Patients are recruited from 4 long term care facilities in The Netherlands.
- Main changes (audit trail)
- RECORD15-nov-2014 - 28-feb-2016

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