NCT02718560

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 4, 2017

Status Verified

April 1, 2017

Enrollment Period

1.8 years

First QC Date

March 15, 2016

Last Update Submit

April 3, 2017

Conditions

Parkinson DiseaseNeurorehabilitationHandwriting

Outcome Measures

Primary Outcomes (1)

  • letters size

    4 weeks

Secondary Outcomes (2)

  • writing speed (time spent to write every single letter and word, measured in milliseconds)

    4 weeks

  • centimeters away from a straight line during writing

    4 weeks

Study Arms (4)

Group 1 - Writing with 1 cm cue

EXPERIMENTAL

This group uses to write space of 1 cm size

Behavioral: Writing

Group 2 - Writing with 1.5 cm cue

EXPERIMENTAL

This group uses to write space of 1.5 cm size

Behavioral: Writing

Group 3 - Writing without cue

EXPERIMENTAL

This group writes without using cues

Behavioral: Writing

Group 4 - no writing

NO INTERVENTION

This group do not write. Only wrist mobilization is performed.

Interventions

WritingBEHAVIORAL

Writing exercise with or without cues for 1 hour per day for 4 days at week for 4 weeks

Group 1 - Writing with 1 cm cueGroup 2 - Writing with 1.5 cm cueGroup 3 - Writing without cue

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parkinson's Disease patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Generale di zona Moriggia Pelascini

Gravedona Ed Uniti, Como, 22015, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Functional Laterality

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dominance, CerebralNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Giuseppe Frazzitta, MD

    Ospedale Generale Di Zona Moriggia-Pelascini

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Ortelli, PsyD

CONTACT

+393332974872ortellipaola73@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 15, 2016

First Posted

March 24, 2016

Study Start

September 1, 2015

Primary Completion

June 1, 2017

Study Completion

September 1, 2017

Last Updated

April 4, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)