Exercise Intervention and Dexterity in Parkinson

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Universidad de Granada
Sponsor:
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada
ClinicalTrials.gov Identifier:
NCT01749917
First received: December 12, 2012
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Parkinson
Other: Exercise program

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Therapeutic Intervention in Motor Disorders in Parkinson.

Resource links provided by NLM:


Further study details as provided by Universidad de Granada:

Primary Outcome Measures:
  • Manual dexterity [ Time Frame: baseline, 6 months ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: baseline, 6 months ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: baseline, 6 months. ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: baseline, 6 months. ] [ Designated as safety issue: Yes ]

    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. [ Time Frame: baseline, 6 months. ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 40
Study Start Date: December 2012
Estimated Study Completion Date: July 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo group
20 people are recruited in order to the inclusion criteria for the study. Placebo controlled. 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.
Active Comparator: Exercise program group
20 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.
Other: Exercise program

Exercise program An exercise program including proprioceptive and balance activities during 6 weeks, 3 times per week is conducted by a physical therapist in patients with parkinson.

A brief intervention with a plaster of resistance is also developed according to a protocol of exercises. It takes 20 minutes. After the intervention, grip strength, pressure pain measure, dexterity and neurodynamics.

Other Names:
  • Proprioceptive and balance activities
  • Plaster of resistance activities

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749917

Contacts
Contact: Carmen Valenza, Ph, MD 958 248035 cvalenza@ugr.es

Locations
Spain
Faculty of Health Sciences. University of Granada. Recruiting
Granada, Andalucia, Spain, 18071
Contact: M. Carmen Valenza, Ph, MD    958 248035    cvalenza@ugr.es   
Principal Investigator: M. Carmen Valenza, Ph, MD         
Sponsors and Collaborators
Universidad de Granada
Investigators
Principal Investigator: M. Carmen Valenza, PH MD Department of Physical Therapy. University of Granada.
  More Information

No publications provided

Responsible Party: Marie Carmen Valenza, Assistant professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT01749917     History of Changes
Other Study ID Numbers: DF0036UG
Study First Received: December 12, 2012
Last Updated: January 21, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Universidad de Granada:
Parkinson.
Dexterity.
Balance.
Exercises.

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 28, 2014