Trial Outcomes & Findings for Could Tai-chi Help Maintain Balance of Spinocerebellar Ataxia Patients (NCT NCT03687190)

NCT ID: NCT03687190

Last Updated: 2023-08-30

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

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

Results posted on

2023-08-30

Participant Flow

Participant milestones

Participant milestones
Measure
Tai Chi
participants in this group accepted Tai chi exercise and conventional medicine. 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 9 months conventional medicine: participants without Tai chi training still received routine conventional medicine
Controlled Group
participants were not received Tai chi exercise, but only routine conventional medicine conventional medicine: participants without Tai chi training still received routine conventional medicine
Overall Study
STARTED
12
9
Overall Study
COMPLETED
12
9
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Could Tai-chi Help Maintain Balance of Spinocerebellar Ataxia Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Tai Chi
n=12 Participants
Subjects accepted Tai Chi exercise once a week in the hospital, and home-based training with a video.
Controlled Group
n=9 Participants
No Tai Chi training. Only regular out-patient clinic visiting.
Total
n=21 Participants
Total of all reporting groups
Age, Continuous
51.5 years
n=5 Participants
51 years
n=7 Participants
51 years
n=5 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
3 Participants
n=7 Participants
9 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
6 Participants
n=7 Participants
12 Participants
n=5 Participants
scale for assessment and rating of ataxia
9 units on a scale
n=5 Participants
9.5 units on a scale
n=7 Participants
9.5 units on a scale
n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure
Tai Chi
n=12 Participants
Subjects accepted Tai Chi exercise once a week in the hospital, and home-based training with a video. We measured the SARA before and after the nine months.
Controlled Group
n=9 Participants
No Tai Chi training. Only regular out-patient clinic visiting. We measured the SARA before and after the nine months.
Scale for the Assessment and Rating of Ataxia(SARA)
11.5 score on a scale
Interval 8.5 to 12.5
9 score on a scale
Interval 7.0 to 12.5

Adverse Events

Tai Chi

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Controlled Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chung-Min Chiu

Changhua Christian Hospital

Phone: *886-982-506-067

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place