Effects Of Tai Chi Exercises With Cycling Exercises On Balance, Gait And Quality Of Life In Sub-Acute Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Dynamic Gait Index
研究概览
简要总结
Stroke, a debilitating cerebrovascular event, frequently leads to severe motor and sensory impairments resulting in a diminished quality of life. Tai Chi, an ancient Chinese martial art known for its slow, flowing movements, emphasis on breath control, and mindfulness, presents an intriguing avenue for stroke rehabilitation. While cycling exercises facilitates muscle control of the lower limbs, which may allow putting more weight on the affected leg while standing, also beneficial for stroke survivors.
详细描述
This is two-arm parallel design randomized controlled trial. Participants will be selected by non-probability consecutive sampling technique, fifty stroke patients meeting the inclusion criteria will be randomly allocated into two groups (experimental and control) by online randomizer tool. The experimental group will receive tai chi exercises with cycling exercises and the control group will receive tai chi exercises alone. Treatment session of 60 min will be given 3 times a week for 6 weeks. The following primary and secondary assessment tools will be used, Functional Reach Test and Berg Balance scale for balance, Dynamic Gait Index and Wisconsin Gait Scale for gait assessment and Stroke Specific Quality of life (SS-QOL). The data will be analyzed using SPPS software version. 26.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with the age ranged between 50-65 years.
- •Participants with either gender.
- •Patients who are in the sub-acute phase (from 2 weeks to less than 3 months after onset).
- •No visual field defect.
- •No abnormality of the vestibular organs.
- •No orthopedic disease.
- •The ability to understand and perform the exercise as instructed by the researcher
- •Muscle power of at least grade three.
- •Could walk at least 10 meters with or without assistive devices.
排除标准
- •Chronic stroke patient.
- •Participants with aphasia and cognitive impairment.
- •Cardiac arrhythmias
- •Any condition for which exercise is contraindicated
- •Fracture of the lower limb.
- •Participants who are currently participating in another clinical trial or research study.
结局指标
主要结局
Dynamic Gait Index
时间窗: 6 weeks
The DGI is developed to assess the likelihood of falling in older adults. It is designed to test eight facets of gait. Equipment needed: Box (Shoebox), Cones (2), Stairs, 20' walkway, 15" wide. Completion time is 15 minutes. A four-point ordinal scale, ranging from 0-3 is used for scoring. "0" indicates the lowest level of function and "3" the highest level of function. Total Score = 24. The ICC2 for intra-rater and inter-rater reliability of total DGI scores is 0.86 and 0.91 respectively.
Berg Balance Scale
时间窗: 6 Weeks
Balance will be measured using the Berg Balance Scale (BBS).The BBS is a 14-item scale that quantitatively assesses balance through direct observations of the performance ability, with each item scored from 0 ('inability to complete the task') to 4 ('independent completion'). The total possible score is 56 points, with higher scores indicating that the person has better balance. The berg balance scale reliability is 0.98, validity: r=0.91
Stroke Specific Quality Of Life (SS-QOL):
时间窗: 6 weeks
The perceived QOL will be measured using the Korean version of the Stroke-Specific Quality of Life questionnaire (SS-QOL), which evaluates the level of energy, family roles, language, mobility, mood, social roles, personality, thinking, and self-care using a 5-point Likert scale. The validity of psychometrics measures of the original version of the scale was reported, with a reliability coefficient of 0.73-0.89. Cronbach's values for the subscales of the SS-QOL were 0.92-0.93 among stroke survivors.
次要结局
未报告次要终点