Somatosensory Dysfunction as the Underlying Mechanism of Upper Limbs Motor Blocks in People With Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02610257
• Date of registration: 17/11/2015
• Prospective Registration: Yes
• Primary sponsor: Katholieke Universiteit Leuven
• Public title: Somatosensory Dysfunction as the Underlying Mechanism of Upper Limbs Motor Blocks in People With Parkinson's Disease
• Scientific title: The Role of Somatosensory Dysfunction as the Underlying Mechanism of Upper Limbs Motor Blocks in People With Parkinson's Disease With and Without Freezing of Gait
• Date of first enrolment: January 2016
• Target sample size: 45
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02610257
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Screening. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Belgium

Contacts

• Name: Alice Nieuwboer, Professor
• Affiliation: Katholieke Universiteit Leuven

Key inclusion & exclusion criteria

Inclusion Criteria:

- PD patients (N=30):

- Diagnosis of PD based on the UK PD brain bank criteria

- Hoehn & Yahr stage II-III (ON-medication)

Exclusion Criteria:

- Cognitive dysfunction Score on the Mini Mental State Examination (MMSE) < 23/30

- Medication change in the past 1 month

- Other neurological disorders

- Vestibular disorder

- Uncontrolled diabetes

- Cutaneous diseases

- Left-handedness



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

Health Condition(s) or Problem(s) studied

Somatosensory Disorders

Parkinson's Disease

Intervention(s)

Device: Mechanical stimulus (vibration) applied on the forearm

Primary Outcome(s)

Joint Position Sense [Time Frame: 15 min]

Perceptual Threshold of Touch [Time Frame: 15 min]

Change in upper limb motor blocks duration [Time Frame: 30 min]

Secondary Outcome(s)

Writing amplitude assessed by a tablet [Time Frame: 30 min]

Somatosensory Function [Time Frame: 30 min]

Secondary ID(s)

S58674

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.