Condition category
Circulatory System
Date applied
25/08/2016
Date assigned
10/09/2016
Last edited
22/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A stroke is a serious, life-threatening medical condition that occurs when the blood supply to part of the brain is cut off. The injury to the brain caused by a stroke can lead to widespread and long-lasting problems. Tai chi is a health-promoting exercise that combines deep breathing and relaxation with slow and gentle movements. A seated and lying Tai Chi model has been developed that is easier for the elderly, people with disabilities, and especially for stroke patients. The aim of this study is to find out whether the easy Tai Chi exercise could improve stroke patients' mental condition, muscle power, and quality of life.

Who can participate?
Stroke patients aged 18 and over who have had disabilities of the limbs for longer than 6 months

What does the study involve?
Participants attend 12 practice sessions (90 minutes per session) led by a Tai Chi master and practice at home for 60 minutes per day for three months. The participants' mental condition, muscle power, and quality of life are assessed before practicing Tai Chi and after practicing Tai Chi for three months.

What are the possible benefits and risks of participating?
The participants may improve their mental condition, muscle power, and quality of life. Although Tai Chi is not a heavy exercise, the body is still moving during exercise. When the patients practice Tai Chi in a sitting position, the participants have to be in a better condition to move and keep balanced, or the patients could choose Tai Chi in a lying position.

Where is the study run from?
The study has been set up by the Department of Neurology, E-Da Hospital in collaboration with Kaohsiung Medical University and Chang Gung Memorial Hospital-Kaohsiung Medical Center (Taiwan)

When is the study starting and how long is it expected to run for?
October 2014 to June 2015

Who is funding the study?
E-Da Hospital (Taiwan)

Who is the main contact?
1. Dr Lian-Hui Lee (brucel-k@yahoo.com.tw)
2. Prof. Hwai-Ting Lin (whiting@kmu.edu.tw)

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hwai-Ting Lin

ORCID ID

http://orcid.org/0000-0002-9916-2119

Contact details

100
Shih-Chuan 1st Road
Kaohsiung
807
Taiwan
+886 (0)7 3121101 ext 2646 617
whiting@kmu.edu.tw

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EMRP17103N

Study information

Scientific title

Development of a Direction-Oriented Motion and Short-Seated and Lying Tai Chi (DOM-SSLTC) model for stroke patients

Acronym

DOM-SSLTC Model for Stroke Patients

Study hypothesis

A Direction-Oriented Motion and Short-Seated and Lying Tai Chi (DOM-SSLTC) model can be performed easily, for stroke patients, and is helpful for their mental, muscle strengthening, and quality of life.

Ethics approval

Institutional Review Board of the E-Da Hospital, 10/09/2014, ref: EMRP17103N

Study design

Non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Home

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Stroke

Intervention

18 stroke patients were recruited to perform the patient-based DOM-SSLTC model. The Direction-Oriented Motion and Short-Seated and Lying Tai Chi (DOM-SSLTC) model is composed of nine typical movements of the Yang-style Tai Chi form divided into Ma Bu and Gong Bu posture, and four motion directions (medial-lateral, forward-backward, rotation, and upward-downward) in sitting and lying positions. All patients received 12 practice sessions (90 minutes per session) led by a Tai Chi master to ensure a uniform technique and consistent experience and practiced at home for 60 min per day for three months.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Outcomes are measured before practicing Tai Chi (baseline) and after practicing Tai Chi for three months.
1. The National Institutes of Health Stroke Scale (NIHSS): a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit, has 15 items, 3 to 5 grades with 0 is normal
2. Modified Ashworth Scale: evaluated muscle spasticity, from grade 0 (No increase in muscle tone) to grade 5 (Affected part(s) rigid in flexion or extension)
3. Modified Rankin Scale: commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability, The scale runs from 0-6, running from perfect health without symptoms to death
4. Barthel Index: the scoring point for the statement that most closely corresponds to the patient's current level of ability for each of the 10 activities of daily living
5. Psychology test with Taiwanese Depression Questionnaire: evaluated depression scale, a 4-point scale with 18 items, is a culturally specific depression self-rating instrument for effective screening of depression in Taiwan

Secondary outcome measures

Outcomes are measured before practicing Tai Chi (baseline) and after practicing Tai Chi for three months.
1. Muscle power of the trunk flexor muscles, assessed via sit-ups with knee bended and hand alternately touching the opposite bended knee.
2. Muscle power of the rectus femoris, assessed by the leg alternately stretched on sitting.
The repetitions of both motions were measured for one min with same height chair for leg test and lying with 10 cm hard mat as pillow with knee bending.

Overall trial start date

15/10/2014

Overall trial end date

30/06/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged ≥18 years
2. Disability status based on the modified Ranking scale 2-4 (mild-to-moderately severe disability)
3. Post-stroke disabilities of the limbs longer than 6 months
4. Cleared for major cardiac and respiratory medical diseases
5. No contraindications for doing Tai Chi exercises

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

18

Participant exclusion criteria

1. Disability status on modified Ranking scale is 1
2. Cannot do the Tai Chi exercises

Recruitment start date

15/10/2014

Recruitment end date

30/06/2015

Locations

Countries of recruitment

Taiwan

Trial participating centre

E-Da Hospital
Kaohsiung
824
Taiwan

Sponsor information

Organisation

E-Da Hospital

Sponsor details

No.1
Yida Road
Jiaosu Village
Yanchao District
Kaohsiung
824
Taiwan

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

E-Da Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Available on request

Results - basic reporting

See additional file ISRCTN12392057_BasicResults_02Sep16.docx

Publication summary

Publication citations

Additional files

Editorial Notes