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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01749917
Other study ID # DF0036UG
Secondary ID
Status Completed
Phase N/A
First received December 12, 2012
Last updated November 1, 2016
Start date December 2012
Est. completion date February 2015

Study information

Verified date November 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

The investigators conducted an intervention based in proprioceptive exercises and balance tasks. The investigators also carried out a brief intervention in manual dexterity.

The study hypothesis is that a brief intervention in upper extremities and a exercise program can increase functionality in Parkinson.


Description:

Motor symptoms in Parkinson frequently affect upper extremities. This has been associated in previous studies with limitation in the performance of activities of daily living and, consequently, with a decrease in quality of life. The possibility that a brief intervention improves eye-hand dexterity in Parkinson's, may be a therapeutic option to improve the performance of activities of daily living. The investigators also conducted an intervention based in proprioceptive exercises and balance tasks to improve functionality.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 65 Years
Eligibility Inclusion Criteria:

- Subjects diagnosed with Parkinson attending to the Parkinson Association of Granada.

- Subjects who can complete the assessment battery of tests at the beginning and at the end of the study.

Exclusion Criteria:

- Auditive and visual disturbances.

- Cognitive problems.

- Psychiatric pathology.

- Sensorial disturbances.

- Traumatic pathology of the hand.

- Concomitant neurological conditions.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Exercise program
Exercise program An brief exercise session including proprioceptive and dexterity activities
Control intervention
Active upper limb range of movement exercises for 15 minutes.

Locations

Country Name City State
Spain Faculty of Health Sciences. University of Granada. Granada Andalucia

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Mateos-Toset S, Cabrera-Martos I, Torres-Sánchez I, Ortiz-Rubio A, González-Jiménez E, Valenza MC. Effects of a Single Hand-Exercise Session on Manual Dexterity and Strength in Persons with Parkinson Disease: A Randomized Controlled Trial. PM R. 2016 Feb;8(2):115-22. doi: 10.1016/j.pmrj.2015.06.004. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Manual dexterity Change from baseline to postintervention in dexterity. This is assessed using the Purdue Pegboard Test.
The Purdue pegboard test is a timed physical test used to measure manual dexterity. Test subjects are asked to place small pins into holes in the pegboard using a specific hand and following a specific process.
baseline, 6 months Yes
Secondary Grip strength Grip strength is measured using a Jamar dynamometer with a standard protocol allowing three attempts on each side. During each measurement, patients were sitting with their shoulder adducted and elbow flexed to 90°. The maximum value achieved from all six attempts was used in analyses.
Kg/cm2
baseline, 6 months Yes
Secondary Pressure pain measure The pressure pain threshold for each site (three points in upper extremities) is assessed using the pressure algometer. All assessments were made by the same investigator. All the subjects were trained to familiarize the subjects with the pressure algometry procedure before the measures in an anatomical site different from the chosen sites for this study. baseline, 6 months. Yes
Secondary Nervous assessment Neurodynamic tests are used in upper extremities. It moves most of the nerves between the neck and hand, including the median nerve, radial and ulnar, brachial plexus, spinal nerves and cervical nerve roots.
The patient is placed supine position. It is measured with a goniometer.
baseline, 6 months. Yes
Secondary Risk of falls. The risk of falls is measured with the timed up and go. It measures in seconds, the time taken by an individual to stand up from a standard arm chair,walk a distance of 3 meters, turn, walk back to the chair, and sit down. baseline, 6 months. Yes
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