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

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.

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

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.

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