ParkinsonNCT01749917
Exercise Intervention and Dexterity in Parkinson
A study testing Exercise program in people with Parkinson, run by Universidad de Granada at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Parkinson
- What is being tested?
- Exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2012to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Auditive and visual disturbances.
- Cognitive problems.
- Psychiatric pathology.
- Sensorial disturbances.
- Traumatic pathology of the hand.
- Concomitant neurological conditions.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Health Sciences. University of Granada.
Granada, Andalusia, 18071
About this study
Official title: Therapeutic Intervention in Motor Disorders in Parkinson.
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.
Read the 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.
- Conditions
- Parkinson
- Being tested
- Exercise program, Control intervention
- Keywords
- Parkinson., Dexterity., Balance., Exercises.
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programOther
Also called Plaster of resistance activities
Exercise program An brief exercise session including proprioceptive and dexterity activities
Control interventionOther
Active upper limb range of movement exercises for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 6 months
Secondary outcomes (4)
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
Measured: baseline, 6 months
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.
Measured: baseline, 6 months.
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.
Measured: baseline, 6 months.
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.
Measured: baseline, 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParkinsonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
- Investigators
- M. Carmen Valenza, PH MD, Principal investigator, Department of Physical Therapy. University of Granada.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749917
- Sponsor's protocol ID
- DF0036UG
- Status last verified
- Nov 2016
- First submitted
- 12 Dec 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 26079867
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Intervention in Motor Disorders in Parkinson.
- ClinicalTrials.gov ID
- NCT01749917
- Acronym / sponsor ID
- DF0036UG
- Conditions
- Parkinson
- Keywords
- Parkinson., Dexterity., Balance., Exercises.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Control intervention30 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. |
| Exercise program group | Experimental | Other: Exercise program30 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- Auditive and visual disturbances.
- Cognitive problems.
- Psychiatric pathology.
- Sensorial disturbances.
- Traumatic pathology of the hand.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise programAlso: Plaster of resistance activitiesExercise program An brief exercise session including proprioceptive and dexterity activities | Other | Exercise program group |
| Control interventionActive upper limb range of movement exercises for 15 minutes. | Other | Control group |
Primary outcome
Manual dexterity
Time frame: baseline, 6 months
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.
4 secondary outcomes
Grip strength
Time frame: baseline, 6 months
Pressure pain measure
Time frame: baseline, 6 months.
Nervous assessment
Time frame: baseline, 6 months.
Risk of falls.
Time frame: baseline, 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Background: PubMed 26079867Mateos-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.
- Individual participant dataSharing planned: Undecided
Related trials for Parkinson
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
Enrolling by invitation
Efficacy of Repetitive Transcranial Magnetic Stimulation for Improving Depressive Symptoms in Patients With Parkinson's Disease
Parkinson's Disease, Depression
RecruitingPhase 1/2
KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
Carcinoma, Non-Small-Cell Lung
Active, not recruitingPhase 2
A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
Thymoma, Thymic Carcinoma
Not yet recruitingObservational study
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
Malignant Tumor, Benign Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Carmen Valenza, PH MD principal investigator
Department of Physical Therapy. University of Granada.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program in people with Parkinson, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manual dexterity (time frame: baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01749917, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.