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临床试验/NCT06509646
NCT06509646招募中不适用

Comparison of Tai Chi and Frenkel's Exercises to Improve Balance, Fall Risk and Activities of Daily Living in Patients With Stroke

Riphah International University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
36
试验地点
2
主要终点
The Barthel Index

研究概览

简要总结

The main objective of this study is to compare the effectiveness of Tai Chi and Frenkel's exercises to improve balance, fall risk and activities of daily living in patients with stroke.

详细描述

A total of 44 patients will be recruited after inclusion and exclusion criteria. Patients will be recruited through nonprobability convenience sampling technique and will be randomized through Lottery method into either a Group A or a Group B, and for each group, the number of patients will be identical. Group A will receive Tai Chi exercises for 1-hour class, 3 times per week for 12 weeks along with routine physical therapy. Routine treatment includes range of motion (ROM) exercise, stretching & strengthening exercises, passive movements & gait training. Group A will receive the Tai Chi exercise with conventional treatment and Group B will receive Frenkel's exercise with conventional treatment. Treatment dosage will be 1 session per day of 1 hour class, 2 sets per session, and 5 repetitions per set, 3 times per week and for 12 weeks. Patients will be assessed at baseline and after the treatment using a variety of measurement scales. After the completion of this time period, the assessment of balance, activities of daily living and fall risk will be performed again and will be compared to baseline assessment to check the comparison between 2 interventions. The risk fall will be measured by Stratify Risk Assessment Tool, Activities of daily will be measured by The Barthel Index (BI) , while balance will be assessed by using berg balance scale (BBC). Data will be analyzed by using SPSS (Statistical Package for Social Sciences) 23 version.

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
Single (Outcomes Assessor)

盲法说明

The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated.

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Community-dwelling survivors of stroke who were aged ≥50 years
  • Both genders can participate in the study
  • ≥3 months poststroke
  • The vital signs were stable
  • Survivors of both hemorrhagic and ischemic stroke
  • Modified Rankin Scale 14 score of three or less
  • Short Physical Performance Battery 15 score of 3 to 9
  • Mini-Mental State Exam 16,17 score of 18 or greater.

排除标准

  • The subject is unable to perform exercises.
  • Subjects with diagnosed vestibular disease.
  • The subjects included in the experiment were normal elderly without stroke diseases.
  • The subjects had dyskinesias and could not complete Tai Chi exercises.
  • Serious medical condition (e.g. active cancer treatment.
  • Stroke survivors whom had no disability that would interfere with study participation.
  • Subject taking medications that increases the incidence of fall.
  • Subjects who undergoes strength and balance training in the past 3 months.

结局指标

主要结局

The Barthel Index

时间窗: 12th week

The scoring is as follows: 0 = unable, 1 = needs assistance/help, 2 = independent. The for the ten items are summed and x 5 to get a total score out of 100. Proposed guidelines for interpreting Barthel scores are as follows: scores of 0-20 indicate "total" dependency.

The Berg Balance Scale (BBS)

时间窗: 12th week

The Berg Balance Score (BBS) is the best-known balance measurement tool, originally designed to measure balance in older individuals. It consists of 14 items scored on an ordinal scale of 0 to 4 for a total of 56 points (a higher score indicates lower fall risk)

Fall Risk Assessment Tool (SRATIFY)

时间窗: 12th week

The STRATIFY Scale is a tool used to identify risk factors for falls in hospitalized patients, using a 0-5 score to predict patients who will fall. It consists of five questions that assess the patient's history of falls, agitation, visual impairment, toileting needs, and mobility. The total score may be used to predict future falls, but it is more important to identify risk factors using the scale and then plan care to address those risk factors. The tool has good test-retest reliability and moderate inter-rater reliability

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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