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Improving Dexterous Skills in Parkinson's Disease

NCT02297893 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2016-08-31

No results posted yet for this study

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

Interventions

BEHAVIORAL

Dexterity training program (HOMEDEXT)

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

BEHAVIORAL

Theraband training program

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

Sponsors & Collaborators

  • Luzerner Kantonsspital

    lead OTHER

Principal Investigators

  • René Müri, MD · University of Bern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02297893 on ClinicalTrials.gov