Improving Dexterous Skills in Parkinson's Disease

NCT02297893 | Completed DMC

• 1 other identifier: Luzerner Kantonsspital
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

Background and aim: Patients with Parkinson's disease (PD) exhibit disturbed manual dexterity. This impairment leads to difficulties in activities of daily living (ADL) such as buttoning a T-shirt or hand-writing. The aim of the present research project is to investigate the effectiveness of a high intensity home based exercise intervention focusing on fine motor skills (HOMEDEXT), in patients with PD. Design: A single blinded randomized controlled trial (RCT) will be performed. Randomization will be done by an independent biostatistician who will use a computerized randomization protocol. A baseline assessment and a follow-up measurement 4 weeks immediately after intervention (end of rehabilitation) will be performed. A follow-up measurement, 12 weeks later, will be done to assess long-lasting effects. Assessments will be performed by investigators who are blinded for the intervention. Participants: One hundred and four out-patients with PD will be recruited who report specific difficulties in manual dexterity when executing ADL. Intervention: The patients will be allocated to either an intervention group (n = 52) or control group (n = 52). In the intervention group PD patients will exercise, over a period of four weeks, once/day during 30 minutes a treatment with specific exercises for dexterity. The PD patients, who will be allocated to the control group, will exercise Theraband exercises. Outcome measures: The primary outcome measures for manual dexterity will be the Nine Hole Peg test. Secondary outcome measures will be the Coin Rotation task, a sensitive screening for dexterity. Furthermore for ADL a modified version of the subscale II of the Movement Disorders Society unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be used. Parkinsonian symptoms will be assessed by the MDS-UPDRS subscale III. To assess improvements in quality of life a modified version of the Parkinson's Disease Questionnaire (PDQ-39) will be used.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Nine Hole Peg Test

  2 minutes

Secondary Outcomes (4)

• Coin Rotation task

  4 weeks

• Modified MDS-UPDRS scale II

  4 weeks

• PDQ-39

  4 weeks

• Dexterity Questionnaire

  4 weeks

Study Arms (2)

Dexterity training program (HOMEDEXT)

EXPERIMENTAL

This program is a a high intensity training program adapted from a previously published arm ability training program

Behavioral: Dexterity training program (HOMEDEXT)

Theraband training program

ACTIVE COMPARATOR

7 different Theraband exercises. Total duration is 30 minutes, trained 5 times a week over a period of 4 weeks

Behavioral: Theraband training program

Interventions

Dexterity training program (HOMEDEXT) BEHAVIORAL

The dexterity training program contains 7 exercises which focus on improving fine motor skills.

Dexterity training program (HOMEDEXT)

Theraband training program BEHAVIORAL

The Theraband training program contains 7 exercises which focus on improving upper limb strength

Theraband training program

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be included if they fulfill the criteria defined by the UK Parkinson's Disease Society Brain Bank Criteria (Hughes et al. 1992), with Hoehn and Yahr stages II to IV.

You may not qualify if:

• Significant medical, psychiatric co-morbidity including dementia as defined by Montreal Cognitive Assessment (MOCA) (Gill et al. 2008)
• Patients who received OT in the last 12 months to avoid carryover effects
• Inability to complete questionnaires (i.e. due to cognitive problems)
• Participation in another intervention trial

Sponsors & Collaborators

• Luzerner Kantonsspital: lead

Study Sites (1)

Luzerner Kantonsspital

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Related Publications (2)

• Vanbellingen T, Kersten B, Bellion M, Temperli P, Baronti F, Muri R, Bohlhalter S. Impaired finger dexterity in Parkinson's disease is associated with praxis function. Brain Cogn. 2011 Oct;77(1):48-52. doi: 10.1016/j.bandc.2011.06.003. Epub 2011 Jul 19.

  PMID: 21775040 BACKGROUND

• Bohlhalter S. [Update on parkinson disease]. Rev Med Suisse. 2013 Jan 30;9(371):247-8. No abstract available. German.

  PMID: 23451586 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• René Müri, MD

  University of Bern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. phil.

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 21, 2014
• Study Start: November 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 31, 2016

Record last verified: 2016-08

Locations

CH (1)