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Goal-oriented Intervention in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02938819
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada

Brief Summary:
Upper-limb disorders in patients with Parkinson's disease include decreased speed and amplitude of movements, difficulty in sequential tasks, and disrupted execution of fine manipulative hand activities.The aim of the study was to evaluate the effects of home-based goal-oriented upper limb intervention in patients with Parkinson's disease.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Other: Goal-oriented upper-limb intervention Other: Standard upper limb intervention Not Applicable

Detailed Description:

Parkinson's disease is a neurodegenerative neurological disorders involving progressive impairment in motor, mood and cognitive functions. Movement disorders have a negative impact on individual's ability to perform well-learned motor skills. These include akinesia, bradykinesia, rigidity and tremor at rest.

A goal-planning process should be useful to ensure that patients agree on the goals of rehabilitation. Thus, the purpose of the study was to evaluate the effects of home-based goal-oriented upper limb intervention in patients with Parkinson's disease.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Goal-oriented Upper-limb Intervention in Patients With Parkinson's Disease
Study Start Date : August 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group
Patients in the experimental group received a Goal-oriented upper limb intervention.
Other: Goal-oriented upper-limb intervention
The Goal-oriented upper-limb intervention evaluated patients' expectations and the environmental factors influencing the performance of the specific task were identified for each of the three tasks. Patients were asked to perform the activity at home. After this, the observable target behavior corresponding to the target activity was determined. Then, an occupational and a physical therapist worked together with the patient to identify the assistance required to perform this activity such as human assistance, technical aids, assistive devices or verbal guidance.

Active Comparator: Control group
Patients in the control group received a standard upper limb intervention
Other: Standard upper limb intervention
The standard upper limb intervention involved active upper limb range of motion, manual dexterity involving grasp and manipulation of small pieces such as marbles and stretching upper limb exercises.




Primary Outcome Measures :
  1. Goals attainment [ Time Frame: Change from baseline goals attainment assessment at 4 weeks. ]
    Attainment of goals was assessed using the Goal Attainment Scaling, a method for quantifying progress on the achievement of specific goals


Secondary Outcome Measures :
  1. Manual dexterity [ Time Frame: Change from baseline manual dexterity at 4 weeks ]
    Manual dexterity was assessed using Purdue Pegboard test (one task with the dominant hand, one with the non-dominant hand, one with both hands and assembly task).

  2. Handgrip strength [ Time Frame: Change from baseline handgrip strength at 4 weeks ]
    Handgrip strength was assessed using a dynamometer

  3. Finger prehension force [ Time Frame: Change from baseline finger prehension force at 4 weeks ]
    Finger prehension force was assessed using a pinch meter



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Parkinson's Disease.
  • Stage II-III of disease progression as defined by the Hoehn and Yahr scale.
  • Upper limbs impairment

Exclusion Criteria:

  • Clinical signs of dementia or psychiatric disturbance.
  • Comprehension deficits that prevented them from following verbal commands.
  • Visual or acoustic limitations.
  • A neurologic condition other than Parkinson's Disease.
  • Musculoskeletal disorders and/or if they had previous trauma or fracture of upper extremity.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938819


Locations
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Spain
Department of Physical Therapy
Granada, Spain, 18071
Sponsors and Collaborators
Universidad de Granada
Investigators
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Principal Investigator: Marie Carmen Valenza, PhD Universidad de Granada

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Responsible Party: Marie Carmen Valenza, PhD, Universidad de Granada
ClinicalTrials.gov Identifier: NCT02938819     History of Changes
Other Study ID Numbers: DF0062UG
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Marie Carmen Valenza, Universidad de Granada:
upper limbs
physiotherapy

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases