Consolidation of Motor Learning of Writing Skills and Its Related Brain Activity Changes in Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2016
• Main ID: NCT02288052
• Date of registration: 03/11/2014
• Prospective Registration: No
• Primary sponsor: Katholieke Universiteit Leuven
• Public title: Consolidation of Motor Learning of Writing Skills and Its Related Brain Activity Changes in Parkinson's Disease
• Scientific title: Consolidation of Motor Learning of Writing Skills and Its Related Brain Activity Changes in Parkinson's Disease
• Date of first enrolment: January 2013
• Target sample size: 42
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02288052
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
• Phase: N/A

Countries of recruitment

Belgium

Contacts

• Name: Alice Nieuwboer, Professor
• Affiliation: KU Leuven

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of PD based on the UK Brain Bank criteria

- Hoehn & Yahr stage I (with impairments on the right side) and II in the on-phase

- Without cognitive impairment (MMSE >24)

- On stable medication

- Right handed

Exclusion Criteria:

- Deep Brain Stimulator

- Other contra-indications for MR scanning

- Colorblind



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Behavioral: Stretch & Relaxation program

Behavioral: Writing program

Primary Outcome(s)

Change from baseline in writing amplitude (cm) on tablet after 12 weeks, including 6 weeks without training [Time Frame: 12 weeks]

Change from baseline in brain activity during rest (resting state MRI) after 6 weeks of training [Time Frame: 6 weeks]

Change from baseline in brain activity during writing (functional MRI) after 6 weeks of training [Time Frame: 6 weeks]

Change from baseline in writing amplitude (cm) on tablet after 6 weeks of training [Time Frame: 6 weeks]

Change from baseline in Diffusion Tensor Imaging after 6 weeks of training [Time Frame: 6 weeks]

Secondary Outcome(s)

Systematic Screening of handwriting difficulties (writing on paper) - change from baseline in quality score after 12 weeks, including 6 weeks without training [Time Frame: 12 weeks]

Change from baseline in writing fluency (normalized jerk) on tablet after 12 weeks, including 6 weeks without training [Time Frame: 12 weeks]

Change from baseline in dual task effect (DTE) for writing amplitude after 6 weeks of training [Time Frame: 6 weeks]

Change from baseline in Purdue Pegboard test after 12 weeks, including 6 weeks without training [Time Frame: 12 weeks]

Systematic Screening of handwriting difficulties (writing on paper) - change from baseline in quality score after 6 weeks of training [Time Frame: 6 weeks]

Change from baseline in dual task effect (DTE) for writing amplitude after 12 weeks, including 6 weeks without training [Time Frame: 12 weeks]

Transfer of change in writing amplitude to an untrained writing sequence after 12 weeks, including 6 weeks without training [Time Frame: 12 weeks]

Change from baseline in Purdue Pegboard test after 6 weeks of training [Time Frame: 6 weeks]

Change from baseline in writing fluency (normalized jerk) on tablet after 6 weeks of training [Time Frame: 6 weeks]

Systematic Screening of handwriting difficulties (writing on paper) - change from baseline in writing speed after 12 weeks, including 6 weeks without training [Time Frame: 12 weeks]

Systematic Screening of handwriting difficulties (writing on paper) - change from baseline in writing speed after 6 weeks of training [Time Frame: 6 weeks]

Transfer of change in writing amplitude to an untrained writing sequence after 6 weeks of training [Time Frame: 6 weeks]

Secondary ID(s)

G.0906.11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Research Foundation Flanders