- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03687190
Could Tai-chi Help Maintain Balance of Spinocerebellar Ataxia Patients
August 29, 2023 updated by: Chiu Chung Min, Changhua Christian Hospital
Integrative Medicine and Tai-chi in Clinical Status of Spinocerebellar Ataxia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tai chi
participants in this group accepted Tai chi exercise and conventional medicine.
|
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
participants without Tai chi training still received routine conventional medicine
|
Active Comparator: controlled group
participants were not received Tai chi exercise, but only routine conventional medicine
|
participants without Tai chi training still received routine conventional medicine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scale for the Assessment and Rating of Ataxia(SARA)
Time Frame: assessed at baseline and 9 months, 9 months reported as Outcome Measure Data
|
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)
|
assessed at baseline and 9 months, 9 months reported as Outcome Measure Data
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lun-Chien Lo, Director of Chinese Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 13, 2013
Primary Completion (Actual)
December 2, 2015
Study Completion (Actual)
December 2, 2015
Study Registration Dates
First Submitted
September 26, 2018
First Submitted That Met QC Criteria
September 26, 2018
First Posted (Actual)
September 27, 2018
Study Record Updates
Last Update Posted (Actual)
August 30, 2023
Last Update Submitted That Met QC Criteria
August 29, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Genetic Diseases, Inborn
- Neurodegenerative Diseases
- Dyskinesias
- Spinal Cord Diseases
- Heredodegenerative Disorders, Nervous System
- Cerebellar Diseases
- Ataxia
- Cerebellar Ataxia
- Spinocerebellar Ataxias
- Spinocerebellar Degenerations
Other Study ID Numbers
- 121013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spinocerebellar Ataxias
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University of FloridaAcorda TherapeuticsCompletedSpinocerebellar Ataxias Type 1 | Spinocerebellar Ataxias Type 2 | Spinocerebellar Ataxias Type 3 | Spinocerebellar Ataxias Type 6United States
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Hasan Kalyoncu UniversityCompleted
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Biohaven Pharmaceuticals, Inc.Active, not recruitingSpinocerebellar Ataxia Type 3 | Spinocerebellar Ataxias | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6 | Spinocerebellar Ataxia Type 10 | Spinocerebellar Ataxia Type 7 | Spinocerebellar Ataxia Type 8United States, China
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Institut National de la Santé Et de la Recherche...Biogen; Ionis Pharmaceuticals, Inc.CompletedSpinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 7France
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Federico II UniversityCompletedSPINOCEREBELLAR ATAXIA 2Italy
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Sclnow Biotechnology Co., Ltd.Not yet recruitingSpinocerebellar Ataxia Type 3 | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6
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University of California, Los AngelesActive, not recruitingSpinocerebellar Ataxias | Spinocerebellar Ataxia 3 | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6 | MSA-CUnited States
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Cadent TherapeuticsWithdrawnSpinocerebellar Ataxia Type 3 | Spinocerebellar Ataxias | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6 | Spinocerebellar Ataxia Type 10 | Spinocerebellar Ataxia Type 7 | Spinocerebellar Ataxia Type 8 | Spinocerebellar Ataxia Type 17 | ARCA1 - Autosomal Recessive...United States
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Teachers College, Columbia UniversityActive, not recruitingSpinocerebellar Ataxia Type 3 | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6 | Spinocerebellar Ataxia Type 7United States
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University of FloridaUniversity of California, Los Angeles; National Ataxia FoundationRecruitingSpinocerebellar Ataxia Type 3 | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6United States
Clinical Trials on Tai chi
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Harvard University Faculty of MedicineBeth Israel Deaconess Medical Center; Brigham and Women's HospitalCompleted
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Lidian ChenPeking University Third HospitalNot yet recruiting
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Taipei Veterans General Hospital, TaiwanNational Science Council, TaiwanCompleted
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University Hospital, Clermont-FerrandCompleted
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Chang Gung Memorial HospitalCompleted
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Texas Tech University Health Sciences CenterActive, not recruiting
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Massachusetts General HospitalUnknown
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Chen Li TienCompletedExercise TrainingTaiwan
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Tufts Medical CenterMassachusetts General HospitalCompletedChronic Pain | FibromyalgiaUnited States
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Chengdu University of Traditional Chinese MedicineUnknown