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
About this trial
This is an interventional supportive care trial for Spinocerebellar Ataxias
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
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
NCT ID
NCT03687190
First Posted
September 26, 2018
Last Updated
August 29, 2023
Sponsor
Changhua Christian Hospital
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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