Goal-oriented Intervention in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Effects of a Goal-oriented Upper-limb Intervention in Patients With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938819
• Other study ID #: DF0062UG
• Status: Completed
• Phase: N/A
• First received: October 17, 2016
• Last updated: December 13, 2016
• Start date: August 2016
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

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.
• 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.

Locations

Country	Name	City	State
Spain	Department of Physical Therapy	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Goals attainment	Attainment of goals was assessed using the Goal Attainment Scaling, a method for quantifying progress on the achievement of specific goals	Change from baseline goals attainment assessment at 4 weeks.	Yes
Secondary	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).	Change from baseline manual dexterity at 4 weeks	Yes
Secondary	Handgrip strength	Handgrip strength was assessed using a dynamometer	Change from baseline handgrip strength at 4 weeks	Yes
Secondary	Finger prehension force	Finger prehension force was assessed using a pinch meter	Change from baseline finger prehension force at 4 weeks	Yes