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Feasibility study of HD-DRUM - a novel drumming training app for people with Huntington's disease

Not Applicable
Conditions
Improving cognitive and motor symptoms with drumming in people with Huntington's disease
Nervous System Diseases
Registration Number
ISRCTN11906973
Lead Sponsor
Cardiff University
Brief Summary

2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37801351/ Intervention design (added 06/02/2024) 2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39089721/ (added 02/08/2024)

Detailed Description

Not available

Recruitment & Eligibility

Status
Ongoing
Sex
All
Target Recruitment
50
Inclusion Criteria

Current inclusion criteria as of 06/02/2024:
Individuals over the age of 18 years with premanifest or early/moderate manifest HD as confirmed by genetic testing for the presence of the mutant huntingtin allele with a Total Functional Capacity score between 9 and 13, sufficient motor control to perform drumming and on stable medication for a minimum of four weeks prior to enrolment.

Previous inclusion criteria:
Individuals over the age of 18 years with premanifest or early/moderate manifest HD as confirmed by genetic testing for the presence of the mutant huntingtin allele with sufficient motor control to perform drumming and on stable medication for a minimum of four weeks prior to enrolment. They will have participated in at least two cognitive testing sessions for the ENROLL-HD registry to reduce the burden (cognitive data collected within a month prior to pilot will be used as baseline data) and practice effects of repeated testing.

Exclusion Criteria

A history of any other neurological condition than HD and an inability to provide consent.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Feasibility of recruitment will be assessed by recording the number of participants enrolled and consented into the study per clinic per month.<br>2. Retention will be measured by the number of participants who complete the study. Number and study and non-study-related reasons for drop-out will be recorded.<br>3. Acceptability will be measured with a semi-quantitative self-report questionnaire asking participants to rate how engaging/motivating/frustrating the training was, whether the training frequency, duration, and difficulty was appropriate, whether they perceived any beneficial/detrimental training effects, what they liked/disliked and what aspects could be improved. This information will provide feedback for any adjustments that may need to be made to HD-DRUM in preparation for a future RCT.<br>4. Adherence to the training will be automatically tracked with HD-DRUM by recording the frequency and duration of training sessions.
Secondary Outcome Measures
NameTimeMethod
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