Parkinson DiseaseHRPDNCT02718560
Handwriting Rehabilitation in Parkinson Disease
A study testing Writing in people with Parkinson Disease and Neurorehabilitation, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
Trial summary
The aim of the study is to evaluate the efficacy of an intensive handwriting treatment in Parkinson's Disease. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson Disease, Neurorehabilitation, Handwriting
- What is being tested?
- Writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's Disease patients
Who cannot join
- Mini Mental State Examination (MMSE) score < 24
- Left handed subjects
- Subjects with dyskinesias
- Subjects with Deep Brain Stimulation
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale Generale di zona Moriggia Pelascini
Gravedona Ed Uniti, Como, 22015
Paola Ortelli, PsyD, +393332974872, ortellipaola73@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease, Neurorehabilitation, Handwriting
- Being tested
- Writing
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WritingBehavioural
Writing exercise with or without cues for 1 hour per day for 4 days at week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Writing with 1 cm cue | Experimental | This group uses to write space of 1 cm size Receives: Behavioral: Writing |
| Group 2 - Writing with 1.5 cm cue | Experimental | This group uses to write space of 1.5 cm size Receives: Behavioral: Writing |
| Group 3 - Writing without cue | Experimental | This group writes without using cues Receives: Behavioral: Writing |
| Group 4 - no writing | No intervention | This group do not write. Only wrist mobilization is performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
letters size
Measured: 4 weeks
Secondary outcomes (2)
writing speed (time spent to write every single letter and word, measured in milliseconds)
Measured: 4 weeks
centimeters away from a straight line during writing
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionJun 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini
- Investigators
- Giuseppe Frazzitta, MD, Principal investigator, Ospedale Generale Di Zona Moriggia-Pelascini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718560
- Sponsor's protocol ID
- Handwriting rehab in PD
- Acronym
- HRPD
- Status last verified
- Apr 2017
- First submitted
- 15 Mar 2016
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intensive Handwriting Rehabilitation in Subjects With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02718560
- Acronym / sponsor ID
- HRPD / Handwriting rehab in PD
- Conditions
- Parkinson Disease, Neurorehabilitation, Handwriting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 24 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Writing with 1 cm cue | Experimental | Behavioral: WritingThis group uses to write space of 1 cm size |
| Group 2 - Writing with 1.5 cm cue | Experimental | Behavioral: WritingThis group uses to write space of 1.5 cm size |
| Group 3 - Writing without cue | Experimental | Behavioral: WritingThis group writes without using cues |
| Group 4 - no writing | No intervention | –This group do not write. Only wrist mobilization is performed. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parkinson's Disease patients
Key exclusion criteria (4 listed)
- Mini Mental State Examination (MMSE) score < 24
- Left handed subjects
- Subjects with dyskinesias
- Subjects with Deep Brain Stimulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WritingWriting exercise with or without cues for 1 hour per day for 4 days at week for 4 weeks | Behavioural | Group 1 - Writing with 1 cm cue, Group 2 - Writing with 1.5 cm cue, Group 3 - Writing without cue |
Primary outcome
letters size
Time frame: 4 weeks
2 secondary outcomes
writing speed (time spent to write every single letter and word, measured in milliseconds)
Time frame: 4 weeks
centimeters away from a straight line during writing
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Frazzitta, MD principal investigator
Ospedale Generale Di Zona Moriggia-Pelascini
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Writing in people with Parkinson Disease and Neurorehabilitation, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paola Ortelli, PsyD (+393332974872, ortellipaola73@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
letters size (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.