- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07399522
Home-Based Calligraphic Handwriting Exercises in Parkinson's Disease
A Randomized Controlled Trial of Home-Based Calligraphic Handwriting Exercises in Patients With Parkinson's Disease
Parkinson's disease is a progressive neurodegenerative disorder with no curative treatment currently available. Its symptoms lead to increasing limitations in daily activities, with impairments in manual dexterity being particularly relevant. Handwriting difficulties are common in patients with Parkinson's disease; however, it remains unclear whether a rehabilitation program based on handwriting exercises can improve overall manual dexterity and daily functioning.
This randomized, single-blind controlled trial aims to evaluate the effects of a 12-week home-based calligraphic handwriting exercise program on manual dexterity in patients with Parkinson's disease. Participants will be recruited from the Movement Disorders Clinic of Hospital 12 de Octubre (Madrid, Spain) and randomly assigned to either an intervention group or a control group.
Manual dexterity will be primarily assessed using the Purdue Pegboard Test across scheduled study visits. Secondary outcomes will include measures of dexterity related to activities of daily living, quality of life, and motor function.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
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Madrid, Madrid, Spain
- Hospital Universitario 12 de Octubre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
INCLUSION CRITERIA:
- Patients aged 40 to 80 years
- Clinical diagnosis of Parkinson's disease according to the UK Brain Bank criteria.
- Hoehn and Yahr stage 1 to 4
- Assessed in the ON-medication state (approximately 90 minutes after levodopa intake)
- Stable antiparkinsonian treatment for at least 4 weeks prior to study entry and maintained throughout the study period
EXCLUSION CRITERIA:
- Parkinson's disease-related dementia, defined as a Montreal Cognitive Assessment (MoCA) score < 21
- Upper limb comorbidities unrelated to Parkinson's disease that could interfere ith exercise performance (e.g., arthritis, recent fractures, stroke sequelae, or peripheral neuropathy)
Severe tremor or severe dyskinesias affecting the dominant hand, defined as:
- a score ≥ 3 on UPDRS-III items 20 or 22, or
- score ≥ 2 on UPDRS-IV item 33
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Calligraphic Handwriting Exercise Program
Participants assigned to this group will perform a structured home-based calligraphic handwriting exercise program designed to improve fine motor control and manual dexterity over a 12-week period.
|
A structured home-based calligraphic handwriting exercise program designed to train fine motor control and manual dexterity.
Participants perform predefined handwriting exercises regularly over a 12-week period using provided written materials.
|
|
No Intervention: Usual Care
Participants assigned to this group will receive usual clinical care and will not participate in the calligraphic handwriting exercise program during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Manual Dexterity
Time Frame: Baseline and up to 12 weeks
|
Manual dexterity will be assessed using the Purdue Pegboard Test.
The primary outcome will be the change in Purdue Pegboard Test score from baseline across scheduled study visits.
|
Baseline and up to 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI21-01622
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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