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Exercise Intervention and Dexterity in Parkinson

Primary Purpose

Parkinson

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise program
Control intervention
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson focused on measuring Parkinson., Dexterity., Balance., Exercises.

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Health Sciences. University of Granada.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Exercise program group

Arm Description

30 people are recruited in order to the inclusion criteria for the study. The study include subjects who can complete the assessment battery of tests at the beginning and end in order to perform the control intervention.

30 people are recruited, diagnosed with Parkinson attending to the Parkinson Association of Granada aged between 40 and 65 years. No sex differences. The study include subjects who can complete the assessment battery of tests at the beginning and end.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
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.

Full Information

First Posted
December 12, 2012
Last Updated
November 1, 2016
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT01749917
Brief Title
Exercise Intervention and Dexterity in Parkinson
Official Title
Therapeutic Intervention in Motor Disorders in Parkinson.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson
Keywords
Parkinson., Dexterity., Balance., Exercises.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
30 people are recruited in order to the inclusion criteria for the study. The study include subjects who can complete the assessment battery of tests at the beginning and end in order to perform the control intervention.
Arm Title
Exercise program group
Arm Type
Experimental
Arm Description
30 people are recruited, diagnosed with Parkinson attending to the Parkinson Association of Granada aged between 40 and 65 years. No sex differences. The study include subjects who can complete the assessment battery of tests at the beginning and end.
Intervention Type
Other
Intervention Name(s)
Exercise program
Other Intervention Name(s)
Plaster of resistance activities
Intervention Description
Exercise program An brief exercise session including proprioceptive and dexterity activities
Intervention Type
Other
Intervention Name(s)
Control intervention
Intervention Description
Active upper limb range of movement exercises for 15 minutes.
Primary Outcome Measure Information:
Title
Manual dexterity
Description
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.
Time Frame
baseline, 6 months
Secondary Outcome Measure Information:
Title
Grip strength
Description
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
Time Frame
baseline, 6 months
Title
Pressure pain measure
Description
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.
Time Frame
baseline, 6 months.
Title
Nervous assessment
Description
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.
Time Frame
baseline, 6 months.
Title
Risk of falls.
Description
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.
Time Frame
baseline, 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Carmen Valenza, PH MD
Organizational Affiliation
Department of Physical Therapy. University of Granada.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Health Sciences. University of Granada.
City
Granada
State/Province
Andalucia
ZIP/Postal Code
18071
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26079867
Citation
Mateos-Toset S, Cabrera-Martos I, Torres-Sanchez I, Ortiz-Rubio A, Gonzalez-Jimenez 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. Epub 2015 Jun 14.
Results Reference
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Exercise Intervention and Dexterity in Parkinson

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