NCT01749917

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

December 12, 2012

Last Update Submit

November 1, 2016

Conditions

Parkinson

Keywords

Parkinson.Dexterity.Balance.Exercises.

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Grip strength

    baseline, 6 months

  • Pressure pain measure

    baseline, 6 months.

  • Nervous assessment

    baseline, 6 months.

  • Risk of falls.

    baseline, 6 months.

Study Arms (2)

Control group

ACTIVE COMPARATOR

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.

Other: Control intervention

Exercise program group

EXPERIMENTAL

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.

Other: Exercise program

Interventions

Exercise programOTHER

Exercise program An brief exercise session including proprioceptive and dexterity activities

Also known as: Plaster of resistance activities
Exercise program group
Control interventionOTHER

Active upper limb range of movement exercises for 15 minutes.

Control group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Auditive and visual disturbances.
  • Cognitive problems.
  • Psychiatric pathology.
  • Sensorial disturbances.
  • Traumatic pathology of the hand.
  • Concomitant neurological conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences. University of Granada.

Granada, Andalusia, 18071, Spain

Location

Related Publications (1)

  • 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.

    PMID: 26079867BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • M. Carmen Valenza, PH MD

    Department of Physical Therapy. University of Granada.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 12, 2012

First Posted

December 17, 2012

Study Start

December 1, 2012

Primary Completion

December 1, 2014

Study Completion

February 1, 2015

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

ES(1)