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出境医 / 临床实验 / The Effect of Pilates and Elastic Taping on Balance and Postural Control in Early Parkinson's Disease

The Effect of Pilates and Elastic Taping on Balance and Postural Control in Early Parkinson's Disease

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Pilates Other: Elastic taping Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Pilates and Elastic Taping on Balance and Postural Control in Early Parkinson's Disease
Actual Study Start Date : February 16, 2017
Actual Primary Completion Date : October 25, 2019
Actual Study Completion Date : February 26, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Pilates Other: Pilates
In pilates group: Pilates training twice a week for 6 weeks.
Other Name: Elastic Taping
Experimental: Elastic Taping Other: Elastic taping
Elastic taping group: Elastic taping application after the pilates training twice a week for 6 weeks Wait List
No Intervention: Wait List Control
Outcome Measures
Primary Outcome Measures :
  1. Balance [ Time Frame: 7.5 months ]
    Walk Across Test were performed with Neurocom Balance Master System.

  2. Postural control [ Time Frame: 7.5 months ]
    Stability Limits Test was performed with Neurocom Balance Master System.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Other orthopaedic, neurologic or visual disease which could affect ability of balance and walking
  • Unstabl cardiovasvularly disease
  • History of Surgery about Parkinson disease
Contacts and Locations

Locations
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Turkey
Dokuz Eylul University
İzmir, Turkey, 35340
Sponsors and Collaborators
Dokuz Eylul University
Investigators
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Principal Investigator: Evrim Goz Dokuz Eylul University
Tracking Information
First Submitted Date  ICMJE June 9, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date August 5, 2020
Actual Study Start Date  ICMJE February 16, 2017
Actual Primary Completion Date October 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Pilates and Elastic Taping on Balance and Postural Control in Early Parkinson's Disease
Official Title  ICMJE The Effect of Pilates and Elastic Taping on Balance and Postural Control in Early Parkinson's Disease
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Other: Pilates
    In pilates group: Pilates training twice a week for 6 weeks.
    Other Name: Elastic Taping
  • Other: Elastic taping
    Elastic taping group: Elastic taping application after the pilates training twice a week for 6 weeks Wait List
Study Arms  ICMJE
  • Experimental: Pilates
    Intervention: Other: Pilates
  • Experimental: Elastic Taping
    Intervention: Other: Elastic taping
  • No Intervention: Wait List Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2020) 		31
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2019) 		32
Actual Study Completion Date  ICMJE February 26, 2020
Actual Primary Completion Date October 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Other orthopaedic, neurologic or visual disease which could affect ability of balance and walking
  • Unstabl cardiovasvularly disease
  • History of Surgery about Parkinson disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03983785
Other Study ID Numbers  ICMJE DokuzEU
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Evrim Goz, Dokuz Eylul University
Study Sponsor  ICMJE Dokuz Eylul University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Evrim Goz Dokuz Eylul University
PRS Account Dokuz Eylul University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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