Back to resultsGoal-oriented Intervention in Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Goal-oriented upper-limb intervention
Standard upper limb intervention
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring upper limbs, physiotherapy
Eligibility 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.
Sites / Locations
- Department of Physical Therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
Patients in the experimental group received a Goal-oriented upper limb intervention.
Patients in the control group received a standard upper limb intervention
Outcomes
Primary Outcome Measures
Goals attainment
Attainment of goals was assessed using the Goal Attainment Scaling, a method for quantifying progress on the achievement of specific goals
Secondary Outcome Measures
Manual dexterity
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).
Handgrip strength
Handgrip strength was assessed using a dynamometer
Finger prehension force
Finger prehension force was assessed using a pinch meter
Full Information
NCT ID
NCT02938819
First Posted
October 17, 2016
Last Updated
December 13, 2016
Sponsor
Universidad de Granada
1. Study Identification
Unique Protocol Identification Number
NCT02938819
Brief Title
Goal-oriented Intervention in Parkinson's Disease
Official Title
Effects of a Goal-oriented Upper-limb Intervention in Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
upper limbs, physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patients in the experimental group received a Goal-oriented upper limb intervention.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients in the control group received a standard upper limb intervention
Intervention Type
Other
Intervention Name(s)
Goal-oriented upper-limb intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard upper limb intervention
Intervention Description
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 Measure Information:
Title
Goals attainment
Description
Attainment of goals was assessed using the Goal Attainment Scaling, a method for quantifying progress on the achievement of specific goals
Time Frame
Change from baseline goals attainment assessment at 4 weeks.
Secondary Outcome Measure Information:
Title
Manual dexterity
Description
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).
Time Frame
Change from baseline manual dexterity at 4 weeks
Title
Handgrip strength
Description
Handgrip strength was assessed using a dynamometer
Time Frame
Change from baseline handgrip strength at 4 weeks
Title
Finger prehension force
Description
Finger prehension force was assessed using a pinch meter
Time Frame
Change from baseline finger prehension force at 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Therapy
City
Granada
ZIP/Postal Code
18071
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Goal-oriented Intervention in Parkinson's Disease
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