Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000769482
Ethics application status
Approved
Date submitted
26/04/2016
Date registered
10/06/2016
Date last updated
14/12/2018
Date data sharing statement initially provided
14/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of Ai-Chi intervention on balance and gait performance in individuals with chronic stroke
Scientific title
The effects of Ai-Chi intervention on balance and gait performance in individuals with chronic stroke
Secondary ID [1] 289037 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 298453 0
Condition category
Condition code
Stroke 298614 298614 0 0
Haemorrhagic
Stroke 298787 298787 0 0
Ischaemic
Physical Medicine / Rehabilitation 299012 299012 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive Ai Chi intervention. Ai Chi is an aquatic exercise containing 16 movements invented by Jun Konno in 1993. The spirit of roundness and flow is adapted from Tai Chi, one of Chinese martial arts, and Watsu, a Japanese body-mind relaxation technique. Ai Chi emphasizes gentle, smooth, and broad movements, Participants need to stay in a semi-squat position with shoulders underneath water surface. It is very important to start with breathing exercise followed by arm and leg movements, and finally coordinated whole body movements. Ai Chi exercise includes several components: flexibility, strength, coordination, relaxation, postural control, and balance.
Ai Chi sessions will be delivered by a certificated physiotherapist with 2 year experience in aquatic therapy and Ai Chi. Training frequency will be 60 min per session, 3 sessions per week for a total of 6 weeks. It will be small group sessions taking place in a hydrotherapy pool in Cheng Hsin General Hospital.
Each participant will have a check sheet and it has to be registered at every session in order to monitor adherence.
Intervention code [1] 294587 0
Rehabilitation
Intervention code [2] 294720 0
Treatment: Other
Comparator / control treatment
Participants in active control group will receive conventional aquatic therapy composed of strengthening, movement facilitation, and motor control training. Participants will be instructed by physiotherapist in a small group and the sessions are taking place in hydrotherapy pool in Cheng Hsin General Hospital. Training frequency will be 60 min per session, 3 sessions per week for a total of 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 298105 0
Limit of stability by SMART Balance Master, NeuroCom International, Inc., USA
Timepoint [1] 298105 0
Participants will be assessed within one week before and after the 6-week intervention.
Primary outcome [2] 298257 0
Functional balance performance by Berg balance scale
Timepoint [2] 298257 0
Participants will be assessed within one week before and after the 6-week intervention.
Primary outcome [3] 298258 0
Spatial-temporal parameters of gait by GAITRite system
Timepoint [3] 298258 0
Participants will be assessed within one week before and after the 6-week intervention.
Secondary outcome [1] 323190 0
Motor control of lower extremities by Fugl-Meyer Assessment-LE
Timepoint [1] 323190 0
Participants will be assessed within one week before and after the 6-week intervention.
Secondary outcome [2] 323718 0
Weight bearing distribution by SMART Balance Master, NeuroCom International, Inc., USA
Timepoint [2] 323718 0
Participants will be assessed within one week before and after the 6-week intervention.

Eligibility
Key inclusion criteria
1. age 20 y/0 to 80 y/o
2. at least 6 months after the onset of first stroke
3. ability to walk independently with or without walking aids for at lease 15 m
4. MMSE > 24
5. no previous cardiovascular disease or other neurological disorder
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. history of regular aquatic therapy
2. history of cardiovascular disease
3. pregnancy
4. incontinence
5. open wounds
6. intubation
7. unwillingness to immerse in water

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/05/2016
Date of last participant enrolment
Anticipated
31/07/2017
Actual
1/11/2017
Date of last data collection
Anticipated
Actual
27/12/2017
Sample size
Target
60
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 7838 0
Taiwan, Province Of China
State/province [1] 7838 0
Taipei

Funding & Sponsors
Funding source category [1] 293454 0
University
Name [1] 293454 0
National Yang-Ming University
Country [1] 293454 0
Taiwan, Province Of China
Funding source category [2] 301448 0
Hospital
Name [2] 301448 0
Cheng Hsin General Hospital
Country [2] 301448 0
Taiwan, Province Of China
Primary sponsor type
University
Name
National Yang-Ming University
Address
No.155, Sec.2, Linong Street, Taipei, 112 Taiwan, R.O.C.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 292276 0
Hospital
Name [1] 292276 0
Cheng Hsin General Hospital
Address [1] 292276 0
No.45,Cheng Hsin St.,Pai-Tou,Taipei, Taiwan, R.O.C.
Country [1] 292276 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294897 0
Institutional Review Board of Cheng Hsin General Hospital
Ethics committee address [1] 294897 0
Ethics committee country [1] 294897 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 294897 0
15/01/2016
Approval date [1] 294897 0
06/04/2016
Ethics approval number [1] 294897 0
CHGH-IRB (537)105-06

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65250 0
Miss Ku, Pei-Hsin
Address 65250 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University
No.155, Sec.2, Linong Street, Taipei, 112 Taiwan, R.O.C.
Country 65250 0
Taiwan, Province Of China
Phone 65250 0
+886-9-425028
Fax 65250 0
Email 65250 0
[email protected]
Contact person for public queries
Name 65251 0
Wang, Ray-Yau
Address 65251 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University
No.155, Sec.2, Linong Street, Taipei, 112 Taiwan, R.O.C.
Country 65251 0
Taiwan, Province Of China
Phone 65251 0
+886-2-28267210
Fax 65251 0
Email 65251 0
[email protected]
Contact person for scientific queries
Name 65252 0
Wang, Ray-Yau
Address 65252 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University
No.155, Sec.2, Linong Street, Taipei, 112 Taiwan, R.O.C.
Country 65252 0
Taiwan, Province Of China
Phone 65252 0
+886-2-28267210
Fax 65252 0
Email 65252 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to regulations of Ethical Committee, any information and data collected from the subjects (patients) should be confidential and be eliminated after a certain period of time. The clinical findings,however, would be submitted to scientific journal afterwards.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.