Parkinson DiseaseNCT03983785
The Effect of Pilates and Elastic Taping on Balance and Postural Control in Early Parkinson's Disease
A study testing Pilates and Elastic taping in people with Parkinson Disease, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare the effects of pilates training and elastic taping on balance and postural control in early Parkinson's patients. 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?
- Pilates and Elastic taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Feb 2017to 26 Feb 2020
- 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
- Diagnosis of Idiopathic Parkinson Disease
- Mini Mental Test Score≥24
- Modified Hoehn and Yahr Score≤2
- Ability to stand 1 minute independently
- Ability to walk 10 meters
Who cannot join
- Other orthopaedic, neurologic or visual disease which could affect ability of balance and walking
- Unstabl cardiovasvularly disease
- History of Surgery about Parkinson disease
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to compare the effects of pilates training and elastic taping on balance and postural control in early Parkinson's patients.
Read the detailed description
The subjects were randomly divided into 3 groups as pilates, elastic taping and waiting list control group. Individuals were given 60-minute pilates training twice a week for 6 weeks. In addition to Pilates training, elastic taping was applied twice a week for postural correction of the back. Individuals were evaluated for balance and postural control before and after training. Evaluation of clinical balance with Berg Balance Scale and Trunk Impairment Scale; Stability Limits, Sits Up, Normal and Tandem Walking Tests were performed with NeuroCom Balance Master balance and performance system.
- Conditions
- Parkinson Disease
- Being tested
- Pilates, Elastic taping
- Keywords
- Pilates, Elastic Taping, Balance, Postural control, Early Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilatesOther
Also called Elastic Taping
In pilates group: Pilates training twice a week for 6 weeks.
Elastic tapingOther
Elastic taping group: Elastic taping application after the pilates training twice a week for 6 weeks Wait List
| Study group | Role | What they receive |
|---|---|---|
| Pilates | Experimental | Not described Receives: Other: Pilates |
| Elastic Taping | Experimental | Not described Receives: Other: Elastic taping |
| Wait List Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Walk Across Test were performed with Neurocom Balance Master System.
Measured: 7.5 months
Postural control
Stability Limits Test was performed with Neurocom Balance Master System.
Measured: 7.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start16 Feb 2017
- Primary completion25 Oct 2019
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evrim Goz, Dokuz Eylul University
- Investigators
- Evrim Goz, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983785
- Sponsor's protocol ID
- DokuzEU
- Status last verified
- Aug 2020
- First submitted
- 9 Jun 2019
- Last updated
- 5 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pilates and Elastic Taping on Balance and Postural Control in Early Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03983785
- Acronym / sponsor ID
- DokuzEU
- Conditions
- Parkinson Disease
- Keywords
- Pilates, Elastic Taping, Balance, Postural control, Early Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 12 Jun 2019 (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.
The aim of this study was to compare the effects of pilates training and elastic taping on balance and postural control in early Parkinson's patients.
Detailed description
The subjects were randomly divided into 3 groups as pilates, elastic taping and waiting list control group. Individuals were given 60-minute pilates training twice a week for 6 weeks. In addition to Pilates training, elastic taping was applied twice a week for postural correction of the back. Individuals were evaluated for balance and postural control before and after training. Evaluation of clinical balance with Berg Balance Scale and Trunk Impairment Scale; Stability Limits, Sits Up, Normal and Tandem Walking Tests were performed with NeuroCom Balance Master balance and performance system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pilates | Experimental | Other: Pilates |
| Elastic Taping | Experimental | Other: Elastic taping |
| Wait List Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Idiopathic Parkinson Disease
- Mini Mental Test Score≥24
- Modified Hoehn and Yahr Score≤2
- Ability to stand 1 minute independently
- Ability to walk 10 meters
Key exclusion criteria (3 listed)
- Other orthopaedic, neurologic or visual disease which could affect ability of balance and walking
- Unstabl cardiovasvularly disease
- History of Surgery about Parkinson disease
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 |
|---|---|---|
| PilatesAlso: Elastic TapingIn pilates group: Pilates training twice a week for 6 weeks. | Other | Pilates |
| Elastic tapingElastic taping group: Elastic taping application after the pilates training twice a week for 6 weeks Wait List | Other | Elastic Taping |
Primary outcome
Balance
Time frame: 7.5 months
Walk Across Test were performed with Neurocom Balance Master System.
Postural control
Time frame: 7.5 months
Stability Limits Test was performed with Neurocom Balance Master System.
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 5 Aug 2020.
- Derived from this study: PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
- Derived from this study: PubMed 36602886Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Evrim Goz principal investigator
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates and Elastic taping in people with Parkinson Disease, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 5 inclusion and 3 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 5 Aug 2020. 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 Turkey (Türkiye). 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?
Balance (time frame: 7.5 months). The study lists 2 primary outcomes in all. 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 NCT03983785, which also lists 2 linked publications.
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 5 Aug 2020.