Back to resultsHandwriting Rehabilitation in Parkinson Disease (HRPD)
Primary Purpose
Parkinson Disease, Neurorehabilitation, Handwriting
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Writing
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
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
Sites / Locations
- Ospedale Generale di zona Moriggia PelasciniRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Group 1 - Writing with 1 cm cue
Group 2 - Writing with 1.5 cm cue
Group 3 - Writing without cue
Group 4 - no writing
Arm Description
This group uses to write space of 1 cm size
This group uses to write space of 1.5 cm size
This group writes without using cues
This group do not write. Only wrist mobilization is performed.
Outcomes
Primary Outcome Measures
letters size
Secondary Outcome Measures
writing speed (time spent to write every single letter and word, measured in milliseconds)
centimeters away from a straight line during writing
Full Information
NCT ID
NCT02718560
First Posted
March 15, 2016
Last Updated
April 3, 2017
Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
1. Study Identification
Unique Protocol Identification Number
NCT02718560
Brief Title
Handwriting Rehabilitation in Parkinson Disease
Acronym
HRPD
Official Title
Effectiveness of Intensive Handwriting Rehabilitation in Subjects With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (Actual)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the study is to evaluate the efficacy of an intensive handwriting treatment in Parkinson's Disease.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Neurorehabilitation, Handwriting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1 - Writing with 1 cm cue
Arm Type
Experimental
Arm Description
This group uses to write space of 1 cm size
Arm Title
Group 2 - Writing with 1.5 cm cue
Arm Type
Experimental
Arm Description
This group uses to write space of 1.5 cm size
Arm Title
Group 3 - Writing without cue
Arm Type
Experimental
Arm Description
This group writes without using cues
Arm Title
Group 4 - no writing
Arm Type
No Intervention
Arm Description
This group do not write. Only wrist mobilization is performed.
Intervention Type
Behavioral
Intervention Name(s)
Writing
Intervention Description
Writing exercise with or without cues for 1 hour per day for 4 days at week for 4 weeks
Primary Outcome Measure Information:
Title
letters size
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
writing speed (time spent to write every single letter and word, measured in milliseconds)
Time Frame
4 weeks
Title
centimeters away from a straight line during writing
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paola Ortelli, PsyD
Phone
+393332974872
Email
ortellipaola73@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Frazzitta, MD
Organizational Affiliation
Ospedale Generale Di Zona Moriggia-Pelascini
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Generale di zona Moriggia Pelascini
City
Gravedona ed Uniti
State/Province
Como
ZIP/Postal Code
22015
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paola Ortelli, PsyD
Phone
+393332974872
Email
ortellipaola73@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Handwriting Rehabilitation in Parkinson Disease
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