Effects of Seated Tai Chi on Recovery Among Stroke Survivors
Primary Purpose
Stroke, Cardiovascular
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
seated Tai Chi
Usual rehabilitation exercise
Sponsored by
About this trial
This is an interventional other trial for Stroke, Cardiovascular
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years;
- A clinical diagnosis of ischaemic or haemorrhagic stroke;
- A history of first-ever stroke;
- In the subacute stage of stroke;
- Ability to sit independently with or without sitters;
- Ability to use and raise at least one arm while sitting (upper extremity muscle strength≥ Ⅲ);
- Have a primary family caregiver (an unpaid relative, partner, personal friend, or neighbor who provides most assistance to the stroke survivor);
- Be able to communicate in Chinese and provide informed consent;
- Plan to be discharged home.
Exclusion Criteria:
- National Institutes of Health Stroke Scale score >16;
- Impaired cognitive functions (Abbreviated Mental Test, AMT ≤ 7);
- Severe hearing or visual impairment;
- Severe complications after stroke (e.g. limited comprehension and receptive aphasia, venous thrombosis);
- Severe history or existed medical condition (e.g. myocardial infarction, using a cardiac pacemaker or a defibrillator, organ failure, malignancy or mental diseases, another neurological disease: multiple sclerosis or parkinson disease, received thrombolytic therapy or surgery, received joint replacement surgeries or fractures within six months);
- Pregnant or lactating women;
- Prior regular (at least three times/week) Tai Chi practice or other mind-body exercise (e.g. Yoga, Qigong, Ba Duanjin, or mindfulness training) in the past six months;
- Participate in other clinical trials that would affect this study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Control
Arm Description
Usual rehabilitation exercise
Outcomes
Primary Outcome Measures
Change of upper limb function in the body function and structure level
Upper limb function will be measured by Fugl-Meyer Test Upper Limb section. The scale includes eight items related to function of wrist and hand, evaluation results are on a three-point scale ranging from 0 ('unable accomplish') to 2 ('completely accomplish'), and has a maximum score of 66. Higher score indicates better upper limb function.
Change of upper limb function in the activity level
Upper limb function will be measured by Wolf Motor Function Test. It consists of 17 items including time, functional ability and strength domains. Item seven and 14 are strength test with recording the exact weight which the participants can afford. The remaining 15 items are scored ranging from 0 ('does not attempt') to 5 ('movement appears to be normal') and have a total score ranging from 0 to 75. Higher score indicates better function.
Change of balance control
Balance control will be measured by the Berg Balance Scale. Each item is scored ranging from zero to four and have a total score ranging from zero to 56. Higher score indicates better balance control.
Change of sitting balance control
Sitting balance control will be measured by the Trunk Impairment Scale. It consists of three subscales: static sitting balance, dynamic sitting balance and coordination. Each subscale contains three items, 10 items, and four items. The total score ranges from zero to 23 points. A higher score indicates better performance.
Change of depressive symptoms
The 15 items Geriatric Depression Scale short form version will be used to measure the depressive symptoms. Each item scored in a dichotomous format: 1= ('yes'), 0= ('no') in response to symptoms of depression. The total score is summed (range 0-15). Higher score indicates more serious depressive symptoms.
Secondary Outcome Measures
Change of activity of daily living
The Modified Barthel Index will be used to assess activity of daily living. The scale consists of 10 items to score the ability of a patient to care for himself which including feeding, moving, and toileting. The total scores range from 0 to 100. Higher score suggests better activity of daily living.
Change of quality of life
Quality of life will be assessed by Stroke-Specific Quality of Life Scale. It includes 12 areas affected following stroke covered by 49 items. For each item, there are five response options in which the score varies from one to five. Thus, the overall scores range from 49 (worst perception of quality of life) to 245 (best perception of quality of life). Higher scores indicate better quality of life.
Full Information
NCT ID
NCT04138407
First Posted
October 21, 2019
Last Updated
October 22, 2019
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04138407
Brief Title
Effects of Seated Tai Chi on Recovery Among Stroke Survivors
Official Title
The Effects of Seated Tai Chi on Upper Limb Function, Balance Control, Depressive Symptoms, Activity of Daily Living and Quality of Life Among Subacute Stroke Survivors: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2020 (Anticipated)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A randomized controlled trial using seated Tai Chi (TC) as a rehabilitation intervention will be conducted among subacute stroke survivors. It aims to evaluate the effects of seated TC on recovery outcomes among subacute stroke survivors.
Stroke survivors and their unpaid caregivers will be recruited as dyads participants. A number of 160 dyads will be recruited from a neurology department of a Tertiary A level provincial Traditional Chinese Medicine hospital in Mainland China with around 1700 beds.
The study will be conducted in hospital and homes. The participants will be randomly assigned to the seated TC group or the usual exercise group. The study will last for 12 weeks (two-week training in hospital and 10-week self-practice at home) and 4-week followup.
Stroke survivors in the seated TC group will participate a TC master-led, 30-minute seated TC exercise per day, five days per week for two weeks. When they discharge, they will perform the seated TC at home for 10 weeks. Those in the usual exercise group will receive usual exercise which has the same frequency and duration as the seated TC group. They will also perform self-practices at home for 10 weeks. Family caregivers will be encouraged to support the exercise intervention and help with recording the logbook of self-practice at home. Manual and training videos recorded by the same master will be given to the dyads of both groups to facilitate their continuation of self-practice on the day they discharge through WeChat. Biweekly reminder will be sent to the family caregivers by the PI through WeChat during the self-practice and follow-up period. The stroke survivors' upper limb function, balance control, depressive symptoms, activity of daily living, and quality of life will be measured at the following time point: baseline, after the supervised intervention (two weeks), eight weeks, after self-practice intervention (12 weeks) and at the end of follow-up (16 weeks). If the study finds significant effects on recovery among subacute stroke survivors, nursing professionals can act as care coordinators/ advocators to incorporate this culture-based exercise in stroke survivors' rehabilitation programs. Seated TC can be used as a clinically feasible exercise for nurses to work with other healthcare professionals for the promotion and application of evidence-based complementary and alternative therapy in promoting stroke survivors' recovery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cardiovascular
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
Other
Arm Description
Usual rehabilitation exercise
Intervention Type
Other
Intervention Name(s)
seated Tai Chi
Intervention Description
Seated Tai Chi is a redesigned short form of traditional Tai Chi, can be practiced in a chair or wheelchair
Intervention Type
Other
Intervention Name(s)
Usual rehabilitation exercise
Intervention Description
Regular rehabilitation exercise used in participating hospital
Primary Outcome Measure Information:
Title
Change of upper limb function in the body function and structure level
Description
Upper limb function will be measured by Fugl-Meyer Test Upper Limb section. The scale includes eight items related to function of wrist and hand, evaluation results are on a three-point scale ranging from 0 ('unable accomplish') to 2 ('completely accomplish'), and has a maximum score of 66. Higher score indicates better upper limb function.
Time Frame
0,2,8,12,16 weeks post-intervention
Title
Change of upper limb function in the activity level
Description
Upper limb function will be measured by Wolf Motor Function Test. It consists of 17 items including time, functional ability and strength domains. Item seven and 14 are strength test with recording the exact weight which the participants can afford. The remaining 15 items are scored ranging from 0 ('does not attempt') to 5 ('movement appears to be normal') and have a total score ranging from 0 to 75. Higher score indicates better function.
Time Frame
0,2,8,12,16 weeks post-intervention
Title
Change of balance control
Description
Balance control will be measured by the Berg Balance Scale. Each item is scored ranging from zero to four and have a total score ranging from zero to 56. Higher score indicates better balance control.
Time Frame
0,2,8,12,16 weeks post-intervention
Title
Change of sitting balance control
Description
Sitting balance control will be measured by the Trunk Impairment Scale. It consists of three subscales: static sitting balance, dynamic sitting balance and coordination. Each subscale contains three items, 10 items, and four items. The total score ranges from zero to 23 points. A higher score indicates better performance.
Time Frame
0,2,8,12,16 weeks post-intervention
Title
Change of depressive symptoms
Description
The 15 items Geriatric Depression Scale short form version will be used to measure the depressive symptoms. Each item scored in a dichotomous format: 1= ('yes'), 0= ('no') in response to symptoms of depression. The total score is summed (range 0-15). Higher score indicates more serious depressive symptoms.
Time Frame
0,2,8,12,16 weeks post-intervention
Secondary Outcome Measure Information:
Title
Change of activity of daily living
Description
The Modified Barthel Index will be used to assess activity of daily living. The scale consists of 10 items to score the ability of a patient to care for himself which including feeding, moving, and toileting. The total scores range from 0 to 100. Higher score suggests better activity of daily living.
Time Frame
0,2,8,12,16 weeks post-intervention
Title
Change of quality of life
Description
Quality of life will be assessed by Stroke-Specific Quality of Life Scale. It includes 12 areas affected following stroke covered by 49 items. For each item, there are five response options in which the score varies from one to five. Thus, the overall scores range from 49 (worst perception of quality of life) to 245 (best perception of quality of life). Higher scores indicate better quality of life.
Time Frame
0,2,8,12,16 weeks post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years;
A clinical diagnosis of ischaemic or haemorrhagic stroke;
A history of first-ever stroke;
In the subacute stage of stroke;
Ability to sit independently with or without sitters;
Ability to use and raise at least one arm while sitting (upper extremity muscle strength≥ Ⅲ);
Have a primary family caregiver (an unpaid relative, partner, personal friend, or neighbor who provides most assistance to the stroke survivor);
Be able to communicate in Chinese and provide informed consent;
Plan to be discharged home.
Exclusion Criteria:
National Institutes of Health Stroke Scale score >16;
Impaired cognitive functions (Abbreviated Mental Test, AMT ≤ 7);
Severe hearing or visual impairment;
Severe complications after stroke (e.g. limited comprehension and receptive aphasia, venous thrombosis);
Severe history or existed medical condition (e.g. myocardial infarction, using a cardiac pacemaker or a defibrillator, organ failure, malignancy or mental diseases, another neurological disease: multiple sclerosis or parkinson disease, received thrombolytic therapy or surgery, received joint replacement surgeries or fractures within six months);
Pregnant or lactating women;
Prior regular (at least three times/week) Tai Chi practice or other mind-body exercise (e.g. Yoga, Qigong, Ba Duanjin, or mindfulness training) in the past six months;
Participate in other clinical trials that would affect this study.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35387494
Citation
Zhao J, Chau JPC, Chan AWK, Meng Q, Choi KC, Xiang X, Zhao Y, He R, Li Q. Tailored Sitting Tai Chi Program for Subacute Stroke Survivors: A Randomized Controlled Trial. Stroke. 2022 Jul;53(7):2192-2203. doi: 10.1161/STROKEAHA.121.036578. Epub 2022 Apr 7.
Results Reference
derived
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Effects of Seated Tai Chi on Recovery Among Stroke Survivors
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