A Phase 2 interventional study of Handwriting Practice in Parkinson Disease, sponsored by Oxford Brookes University. Terminated at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-28.
Sponsored by Oxford Brookes University · Phase 2, Interventional, and Treatment
Background: Problems with handwriting are frustrating and debilitating and affect the majority of people with Parkinson's. Manifest as micrographia it is a distinctive feature of the condition characterised by small handwriting and/or a progressive reduction in size through a sentence[2] coupled with a reduction in writing speed and legibility.
In Parkinson's impaired automaticity is thought to contribute to handwriting deficits and attention has been shown to improve both 'consistent' (small handwriting) and 'progressive' (progressive reduction in letter size through a sentence) aspects of the symptom. Moreover, recent interventional studies indicate handwriting may be improved through practice. This study is investigating a novel handwriting practice stimulus to improve symptoms of micrograpthia
Question: Is a diverging line cued handwriting intervention potentially more effective at improving symptoms of mircograpthia than a parallel line cued handwriting intervention in people with Parkinson's?
Specifically, an assessor blind randomised controlled exploratory trial will:
Design: A phase II exploratory randomised controlled trial of a handwriting intervention with an active comparator control group and blinded assessments
Setting: The intervention will be carried out at home
Sample size: This study is not designed to determine efficacy. The aim to recruit a total of 50 people (25 people per group) in order to estimate the effects on outcome measures and achieve the aims of this exploratory trial.
Assessment: Participants will be asked to follow their usual Parkinson's medication regime and if they have ON and OFF periods, assessments will be carried out during ON state.
Duration and follow-up: the assessment is schedule 0Weeks (baseline), 6weeks (end intervention) and 12weeks (follow up). Assessments will be carried out by a researcher blind to trial arm allocation using all outcome measures.
4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's enrollment of 48 is above the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Oxford Brookes University is the lead sponsor of 35 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
What: Handwriting practice at home delivered through handwriting workbooks. The workbook consists of diverging lines. Participants will be instructed to write a daily diary (a reflection of their day) aiming for letters letter size to be consistent with the lines. Participant will be instructed to take a long as they need to complete the daily diary and focus and concentrate the handwriting and achieving the size dictated by the lines. They will be asked to do this daily, but at least 5 days a week for 6 weeks. Tailoring and progression: The nature of the handwriting program is that it accounts for individual ability; participant will be asked to write as much as they can during the practice session, whilst concentrating on their handwriting.
Behavioral: Handwriting Practice
What: Handwriting practice at home delivered through handwriting workbooks. The workbook consists of parallel lines. Participants will be instructed to write a daily diary (a reflection of their day) aiming for letters letter size to be consistent with the lines. Participant will be instructed to take a long as they need to complete the daily diary and focus and concentrate the handwriting and achieving the size dictated by the lines. They will be asked to do this daily, but at least 5 days a week for 6 weeks. Tailoring and progression: The nature of the handwriting program is that it accounts for individual ability; participant will be asked to write as much as they can during the practice session, whilst concentrating on their handwriting.
Behavioral: Handwriting Practice
Self-directed home handwriting practice daily for 6 weeks
Micrograpthia: Area of 'el' 8 character text sequence writing task
Area (maximum height x maximum width) of handwritten cursive 'elelelel' character sequence measured to the nearest of 0.5mm
Time frame: 6 weeks
Self-reported problem with handwriting: Item 2.7 on the Movement Disorders Society Unified Parkinson's Rating Scale
A scale from 0-4 (0: normal: no problems, 4: severe: most or all words cannot be read) asking 'Over the past week, have people usually had trouble reading your handwriting?'
Time frame: 6 weeks
Writing speed: Time taken to write an Italian proverb
Time taken to the nearest 10th second to hand write the sentence (written across one line): 'Chi lascia la via vecchia per la nuova, sa quello che lascia ma non sa quello che trova'
Time frame: 6 weeks
Writing amplitude: Area of the both 'lascia' contained in an Italian proverb
Area (maximum height x maximum width) of 'lascia' contained in handwritten sentence: 'Chi lascia la via vecchia per la nuova, sa quello che lascia ma non sa quello che trova'. Measured to the nearest 0.5mm
Time frame: 6 weeks
Micrograpthia under cognative motor interference: Area of 'el' 8 character text sequence writing task
Area (maximum height x maximum width) of handwritten cursive 'elelelel' character sequence performed concurrently with cognative task (serial 3 subtraction). Measured to the nearest of 0.5mm
Time frame: 6 weeks
Micrograpthia under cognative motor interference: Area of 'el' 8 character text sequence writing task
Area (maximum height x maximum width) of handwritten cursive 'elelelel' character sequence performed concurrently with cognative task (serial 3 subtraction). Measured to the nearest of 0.5mm
Time frame: 12 weeks
Legibility of Free writing
Ratio between total number of words written and total number of legible words written during a 5 minutes of free writing task: A reflection on the day
Time frame: 6 weeks
Legibility of Free writing
Ratio between total number of words written and total number of legible words written during a 5 minutes of free writing task: A reflection on the day
Time frame: 12 weeks
EQ-5D-5L
Standardized Instrument to measure health outcome
Time frame: 6 weeks
EQ-5D-5L
Standardized Instrument to measure health outcome
Time frame: 12 weeks
Micrograpthia: Area of 'el' 8 character text sequence writing task
Area (maximum height x maximum width) of handwritten cursive 'elelelel' character
Time frame: 12 weeks
Self-reported problem with handwriting: Item 2.7 on the Movement Disorders Society
0-4 scale (0: normal: no problems, 4: severe: most or all words cannot be read) asking 'Over the past week, have people usually had trouble reading your handwriting?'
Time frame: 12 weeks
Writing speed: Time taken to write an Italian proverb
Time taken to the nearest 10th second to hand write the sentence (written across one line): 'Chi lascia la via vecchia per la nuova, sa quello che lascia ma non sa quello che trova'
Time frame: 12 weeks
Writing amplitude: Area of the both 'lascia' contained in an Italian proverb
Area (maximum height x maximum width) of 'lascia' contained in handwritten sentence: 'Chi lascia la via vecchia per la nuova, sa quello che lascia ma non sa quello che trova'. Measured to the nearest 0.5mm
Time frame: 12 weeks
Plan to share: Undecided
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This study is terminated, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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