- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02938819
Goal-oriented Intervention in Parkinson's Disease
Effects of a Goal-oriented Upper-limb Intervention in Patients With Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Granada, Spain, 18071
- Department of Physical Therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental group
Patients in the experimental group received a Goal-oriented upper limb intervention.
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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.
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Active Comparator: Control group
Patients in the control group received a standard upper limb intervention
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Goals attainment
Time Frame: Change from baseline goals attainment assessment at 4 weeks.
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Attainment of goals was assessed using the Goal Attainment Scaling, a method for quantifying progress on the achievement of specific goals
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Change from baseline goals attainment assessment at 4 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Manual dexterity
Time Frame: Change from baseline manual dexterity at 4 weeks
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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).
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Change from baseline manual dexterity at 4 weeks
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Handgrip strength
Time Frame: Change from baseline handgrip strength at 4 weeks
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Handgrip strength was assessed using a dynamometer
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Change from baseline handgrip strength at 4 weeks
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Finger prehension force
Time Frame: Change from baseline finger prehension force at 4 weeks
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Finger prehension force was assessed using a pinch meter
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Change from baseline finger prehension force at 4 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DF0062UG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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