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Could Tai-chi Help Maintain Balance of Spinocerebellar Ataxia Patients

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ClinicalTrials.gov Identifier: NCT03687190
Recruitment Status : Completed
First Posted : September 27, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Chin-San Liu, Changhua Christian Hospital

Tracking Information
First Submitted Date  ICMJE September 26, 2018
First Posted Date  ICMJE September 27, 2018
Last Update Posted Date September 28, 2018
Actual Study Start Date  ICMJE May 13, 2013
Actual Primary Completion Date December 2, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
Scale for the Assessment and Rating of Ataxia(SARA) [ Time Frame: two years ]
SARA assesses eight aspects of cerebellar function: walking, sitting, standing, speaking, finger chasing, the nose-finger test, fast alternating hand movements, and the heel-shin slide. The eight categories accumulate score ranging from 0 (no ataxia) to 40 (most severe ataxia).Gait (0-8 points),Stance (0-6 points),Sitting (0-4 points),Speech disturbance (0-6 points),Finger chase (0-4 points),Nose-finger test (0-4 points),Fast alternating hand movement (0-4 points),Heel-shin slide (0-4 points).
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
Scale for the Assessment and Rating of Ataxia(SARA) [ Time Frame: two years ]
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 Could Tai-chi Help Maintain Balance of Spinocerebellar Ataxia Patients
Official Title  ICMJE Integrative Medicine and Tai-chi in Clinical Status of Spinocerebellar Ataxia
Brief Summary Spinocerebellar atrophy is the most common autosomal dominant inherited ataxia. There are over thirty subtypes, which characterize neurologic features differently. They all have obvious substantial cerebellar atrophies in image, and unstable gait、ataxia. In general a prevalence of about three cases per 100 000 people is assumed, but this may be an underestimate. Progressive neurologic degeneration, in about 10-20 years, will leads to disability or wheelchair-dependent. Accompanying with fatigue, downhill course of the disease often made patients depressive and hopeless. The recent review of researches concludes no effective therapy for the disease. The purpose of the investigator's study is to explore the Tai-chi exercise effect for spinocerebellar ataxia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Spinocerebellar Ataxias
  • Tai ji
Intervention  ICMJE
  • Behavioral: Tai chi
    participants were required to receive hospital-based Tai chi training at least once a month, and home-based Tai chi exercise at least three times a week over the next 2 years
  • Drug: conventional medicine
    participants without Tai chi training still received routine conventional medicine
Study Arms  ICMJE
  • Experimental: Tai chi
    participants in this group accepted Tai chi exercise and conventional medicine.
    Interventions:
    • Behavioral: Tai chi
    • Drug: conventional medicine
  • Active Comparator: controlled group
    participants were not received Tai chi exercise, but only routine conventional medicine
    Intervention: Drug: conventional medicine
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: September 26, 2018)
46
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2, 2015
Actual Primary Completion Date December 2, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • progressive ataxia accompanied with the observation of cerebellar atrophy on magnetic resonance or computed tomography images
  • SARA score of less than 20

Exclusion Criteria:

  • Patients with complicated cerebellar disorders, such as multiple system atrophy, Parkinson-plus syndromes, secondary cerebellar degeneration from encephalitis, trauma, hypoxia, cerebrovascular diseases, and toxic- or drug-induced cerebellar degeneration
  • SARA score of larger than 20
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03687190
Other Study ID Numbers  ICMJE 121013
Has Data Monitoring Committee Yes
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: No
Responsible Party Chin-San Liu, Changhua Christian Hospital
Study Sponsor  ICMJE Changhua Christian Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chin-San Liu assistant administrator
PRS Account Changhua Christian Hospital
Verification Date September 2018

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