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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

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.

Condition or disease Intervention/treatment Phase
Spinocerebellar Ataxias Tai ji Behavioral: Tai chi Drug: conventional medicine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Integrative Medicine and Tai-chi in Clinical Status of Spinocerebellar Ataxia
Actual Study Start Date : May 13, 2013
Actual Primary Completion Date : December 2, 2015
Actual Study Completion Date : December 2, 2015


Arm Intervention/treatment
Experimental: Tai chi
participants in this group accepted Tai chi exercise and conventional medicine.
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

Active Comparator: controlled group
participants were not received Tai chi exercise, but only routine conventional medicine
Drug: conventional medicine
participants without Tai chi training still received routine conventional medicine




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03687190


Sponsors and Collaborators
Changhua Christian Hospital
Investigators
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Principal Investigator: Chin-San Liu assistant administrator

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Responsible Party: Chin-San Liu, assistant administrator, Changhua Christian Hospital
ClinicalTrials.gov Identifier: NCT03687190     History of Changes
Other Study ID Numbers: 121013
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ataxia
Cerebellar Ataxia
Spinocerebellar Ataxias
Spinocerebellar Degenerations
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases
Spinal Cord Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn