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Could Tai-chi Help Maintain Balance of Spinocerebellar Ataxia Patients

Primary Purpose

Spinocerebellar Ataxias, Tai Chi

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tai chi
conventional medicine
Sponsored by
Changhua Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinocerebellar Ataxias

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Tai chi

    controlled group

    Arm Description

    participants in this group accepted Tai chi exercise and conventional medicine.

    participants were not received Tai chi exercise, but only routine conventional medicine

    Outcomes

    Primary Outcome Measures

    Scale for the Assessment and Rating of Ataxia(SARA)
    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)

    Secondary Outcome Measures

    Full Information

    First Posted
    September 26, 2018
    Last Updated
    August 29, 2023
    Sponsor
    Changhua Christian Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03687190
    Brief Title
    Could Tai-chi Help Maintain Balance of Spinocerebellar Ataxia Patients
    Official Title
    Integrative Medicine and Tai-chi in Clinical Status of Spinocerebellar Ataxia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    May 13, 2013 (Actual)
    Primary Completion Date
    December 2, 2015 (Actual)
    Study Completion Date
    December 2, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Changhua Christian Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinocerebellar Ataxias, Tai Chi

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tai chi
    Arm Type
    Experimental
    Arm Description
    participants in this group accepted Tai chi exercise and conventional medicine.
    Arm Title
    controlled group
    Arm Type
    Active Comparator
    Arm Description
    participants were not received Tai chi exercise, but only routine conventional medicine
    Intervention Type
    Behavioral
    Intervention Name(s)
    Tai chi
    Intervention Description
    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 9 months
    Intervention Type
    Drug
    Intervention Name(s)
    conventional medicine
    Intervention Description
    participants without Tai chi training still received routine conventional medicine
    Primary Outcome Measure Information:
    Title
    Scale for the Assessment and Rating of Ataxia(SARA)
    Description
    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)
    Time Frame
    assessed at baseline and 9 months, 9 months reported as Outcome Measure Data

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lun-Chien Lo
    Organizational Affiliation
    Director of Chinese Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Could Tai-chi Help Maintain Balance of Spinocerebellar Ataxia Patients

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