Could Tai-chi Help Maintain Balance of Spinocerebellar Ataxia Patients

NCT03687190 | Completed Results DMC

• 1 other identifier: 121013
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinocerebellar Ataxias; Tai Chi

Outcome Measures

Primary Outcomes (1)

• 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)

  assessed at baseline and 9 months, 9 months reported as Outcome Measure Data

Study Arms (2)

Tai chi

EXPERIMENTAL

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

Behavioral: Tai chi; Drug: conventional medicine

controlled group

ACTIVE COMPARATOR

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

Drug: conventional medicine

Interventions

Tai chi BEHAVIORAL

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

Tai chi

conventional medicine DRUG

participants without Tai chi training still received routine conventional medicine

Tai chi; controlled group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• progressive ataxia accompanied with the observation of cerebellar atrophy on magnetic resonance or computed tomography images
• SARA score of less than 20

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhua Christian Hospital: lead

MeSH Terms

Conditions

Spinocerebellar Ataxias

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Cerebellar Ataxia; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinocerebellar Degenerations; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Ataxia; Dyskinesias; Neurologic Manifestations; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Limitations and Caveats

There were insufficient case numbers in this study, in both groups. There were patients with different gene types, non-hereditary, or even multiple system atrophy in the recruited subjects.

Results Point of Contact

• Title: Chung-Min Chiu
• Organization: Changhua Christian Hospital

shongdiah@gmail.com

*886-982-506-067

Study Officials

• Lun-Chien Lo

  Director of Chinese Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Physician

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 27, 2018
• Study Start: May 13, 2013
• Primary Completion: December 2, 2015
• Study Completion: December 2, 2015
• Last Updated: August 30, 2023
• Results First Posted: January 27, 2022

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share