Parkinson DiseaseNCT03580096
Core Stability and Parkinson Disease
A study testing Core stability and Standard intervention in people with Parkinson Disease, run by Universidad de Granada at 1 site in Spain.
Trial summary
Patients with Parkinson's Disease frequently present impaired postural control that leads to loss of stability and increased risk of falls.Core system, includes passive structures of the thoracolumbar spine and pelvis that work as a unit to stabilize the body and spine against forces generated from distal body… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Core stability and Standard intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jul 2018to 4 Nov 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's Disease diagnosis.
- Stable medication usage
- Able to maintain standing independent
Who cannot join
- Cognitive impairment
- Comprehension deficits that prevented them from following verbal commands
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Core Stability Exercise in Patients With Parkinson's Disease
Patients with Parkinson's Disease frequently present impaired postural control that leads to loss of stability and increased risk of falls.Core system, includes passive structures of the thoracolumbar spine and pelvis that work as a unit to stabilize the body and spine against forces generated from distal body segments as well as forces generated from expected or unexpected perturbations.The objective of this study was to evaluate the effects of an intervention based on core stability in patients with Parkinson's Disease.
Read the detailed description
Core muscle coordination is important because lack of sufficient core muscle coordination can lead to decreased efficiency of postural control and functional activity. Clinical manifestations of patients with Parkinson's Disease include postural instability. Core system could be relevant to be included in an intervention. Thus, the objective of this study was to evaluate the effects of an intervention based on core stability in patients with Parkinson's Disease.
- Conditions
- Parkinson Disease
- Being tested
- Core stability, Standard intervention
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stabilityOther
Also called Core training
Core stability intervention will be done with different stages and increasing gradually. The training program starts with exercises that isolate specific core muscles but progressing to include complex movements and incorporate core stability in dynamic tasks.
Standard interventionOther
Also called Conventional intervention
Standard intervention will include active exercises based on active joint mobilizations, muscle stretching and motor coordination.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients were included in a core stability intervention. It will be done with different stages and increasing gradually. Receives: Other: Core stability |
| Control group | Active comparator | Standard intervention consisting of exercises aimed at improving balance. Receives: Other: Standard intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dynamic balance
Dynamic balance is going to be assessed with the Mini-Balance Evaluation System Test. It was developed to identify the postural control systems that underly poor functional balance. It contains four subscales: anticipatory postural control, reactive postural control, sensory orientation and stability in gait. It includes 14 items scored on a 3 level ordinal scale. The maximum total score is 28 points with higher scores indicating better balance.
Measured: Change from baseline dynamic balance at 8 weeks
Secondary outcomes (2)
Balance confidence
The perceived level of balance confidence is going to be assessed using the Activities-Specific Balance Confidence Scale (ABC). There are 16 items, representing daily activities. Participants are asked to answer, with a score from 0% (not confident at all) to 100% (completely confident) in increments of 10%. A score lower than 67% suggests substantial risk of falling.
Measured: Baseline, 8 weeks
Static balance
Static balance is going to be assessed using the Wii Balance Board.The 4 sensors in the balance board can sense weight changes and show the distribution of body weight. It will be assessed standing balance with eyes opened and closed, and standing over a foam with eyes opened and closed. Higher time in a stable position indicates greater static balance.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start8 Jul 2018
- Primary completion20 Sep 2018
- Study completion4 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 44 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580096
- Sponsor's protocol ID
- DF0074UG
- Status last verified
- Sep 2019
- First submitted
- 15 Jun 2018
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Core Stability Exercise in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03580096
- Acronym / sponsor ID
- DF0074UG
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 8 Jul 2018 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 4 Nov 2018 (actual)
- First posted
- 9 Jul 2018 (actual)
- 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.
Patients with Parkinson's Disease frequently present impaired postural control that leads to loss of stability and increased risk of falls.Core system, includes passive structures of the thoracolumbar spine and pelvis that work as a unit to stabilize the body and spine against forces generated from distal body segments as well as forces generated from expected or unexpected perturbations.The objective of this study was to evaluate the effects of an intervention based on core stability in patients with Parkinson's Disease.
Detailed description
Core muscle coordination is important because lack of sufficient core muscle coordination can lead to decreased efficiency of postural control and functional activity. Clinical manifestations of patients with Parkinson's Disease include postural instability. Core system could be relevant to be included in an intervention. Thus, the objective of this study was to evaluate the effects of an intervention based on core stability in patients with Parkinson's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Core stabilityPatients were included in a core stability intervention. It will be done with different stages and increasing gradually. |
| Control group | Active comparator | Other: Standard interventionStandard intervention consisting of exercises aimed at improving balance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parkinson's Disease diagnosis.
- Stable medication usage
- Able to maintain standing independent
Key exclusion criteria (2 listed)
- Cognitive impairment
- Comprehension deficits that prevented them from following verbal commands
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 |
|---|---|---|
| Core stabilityAlso: Core trainingCore stability intervention will be done with different stages and increasing gradually. The training program starts with exercises that isolate specific core muscles but progressing to include complex movements and incorporate core stability in dynamic tasks. | Other | Experimental group |
| Standard interventionAlso: Conventional interventionStandard intervention will include active exercises based on active joint mobilizations, muscle stretching and motor coordination. | Other | Control group |
Primary outcome
Change in dynamic balance
Time frame: Change from baseline dynamic balance at 8 weeks
Dynamic balance is going to be assessed with the Mini-Balance Evaluation System Test. It was developed to identify the postural control systems that underly poor functional balance. It contains four subscales: anticipatory postural control, reactive postural control, sensory orientation and stability in gait. It includes 14 items scored on a 3 level ordinal scale. The maximum total score is 28 points with higher scores indicating better balance.
2 secondary outcomes
Balance confidence
Time frame: Baseline, 8 weeks
Static balance
Time frame: Baseline, 8 weeks
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 4 Sep 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core stability and Standard intervention in people with Parkinson Disease, 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 3 inclusion and 2 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 4 Sep 2019. 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?
Change in dynamic balance (time frame: Change from baseline dynamic balance at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2019.