Handwriting Rehabilitation in Parkinson Disease (HRPD)

April 3, 2017 updated by: Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini

Effectiveness of Intensive Handwriting Rehabilitation in Subjects With Parkinson's Disease

The aim of the study is to evaluate the efficacy of an intensive handwriting treatment in Parkinson's Disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators aimed to understand whether an intensive handwriting treatment with cognitive engagement is more effective than a treatment exploiting only the passive wrist joint mobilization in Parkinson's Disease.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Como
      • Gravedona ed Uniti, Como, Italy, 22015
        • Recruiting
        • Ospedale Generale di Zona Moriggia Pelascini
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parkinson's Disease patients

Exclusion Criteria:

  • Mini Mental State Examination (MMSE) score < 24
  • Left handed subjects
  • Subjects with dyskinesias
  • Subjects with Deep Brain Stimulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1 - Writing with 1 cm cue
This group uses to write space of 1 cm size
Behavioral: Writing
Writing exercise with or without cues for 1 hour per day for 4 days at week for 4 weeks
EXPERIMENTAL: Group 2 - Writing with 1.5 cm cue
This group uses to write space of 1.5 cm size
Behavioral: Writing
Writing exercise with or without cues for 1 hour per day for 4 days at week for 4 weeks
EXPERIMENTAL: Group 3 - Writing without cue
This group writes without using cues
Behavioral: Writing
Writing exercise with or without cues for 1 hour per day for 4 days at week for 4 weeks
NO_INTERVENTION: Group 4 - no writing
This group do not write. Only wrist mobilization is performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
letters size
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
writing speed (time spent to write every single letter and word, measured in milliseconds)
Time Frame: 4 weeks
4 weeks
centimeters away from a straight line during writing
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Generale Di Zona Moriggia-Pelascini

Investigators

  • Principal Investigator: Giuseppe Frazzitta, MD, Ospedale Generale Di Zona Moriggia-Pelascini

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2015

Primary Completion (ANTICIPATED)

June 1, 2017

Study Completion (ANTICIPATED)

September 1, 2017

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

March 20, 2016

First Posted (ESTIMATE)

March 24, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2017

Last Update Submitted That Met QC Criteria

April 3, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Handwriting rehab in PD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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