NCT07399522

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration 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

Study Start

First participant enrolled

July 5, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

3.2 years

First QC Date

January 21, 2026

Last Update Submit

February 6, 2026

Conditions

PARKINSON DISEASE (Disorder)

Outcome Measures

Primary Outcomes (1)

  • Change in Manual Dexterity

    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

Study Arms (2)

Calligraphic Handwriting Exercise Program

EXPERIMENTAL

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.

Behavioral: Calligraphic Handwriting Exercise Program

Usual Care

NO INTERVENTION

Participants assigned to this group will receive usual clinical care and will not participate in the calligraphic handwriting exercise program during the study period.

Interventions

Calligraphic Handwriting Exercise ProgramBEHAVIORAL

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.

Calligraphic Handwriting Exercise Program

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Postdoctoral Researcher in Neurology

Study Record Dates

First Submitted

January 21, 2026

First Posted

February 10, 2026

Study Start

July 5, 2022

Primary Completion

September 8, 2025

Study Completion

September 8, 2025

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)