跳至主要内容
临床试验/NCT07063368
NCT07063368招募中不适用

Combined Effects of Otago Exercises and Systematic Desensitization on Balance,Fall Risk and Basophobia Among Post Stroke Older Adults

Riphah International University1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2025年6月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
51
试验地点
1
主要终点
Fall Risk Assessment Scale

研究概览

简要总结

The aim of the study is to determine the combined effects of Otago exercises and systematic desensitization on balance, fall risk, and basophobia among post-stroke older adults.

详细描述

Stroke survivors often face challenges such as impaired balance, heightened fall risk, and basophobia (fear of falling), which significantly impact their daily lives and rehabilitation outcomes. Stroke patients have a two-fold higher risk of falling than other patients of the same age or gender.In particular, 30% to 50% of the elderly those over 65 years old, experience falls every year. The Otago Exercise Program, recognized for its efficacy in improving balance and reducing falls among older adults, and systematic desensitization, a psychological intervention aimed at reducing fear and anxiety related to falling, offer complementary approaches to address these challenges. This study aims to investigate the combined effects of Otago exercises and systematic desensitization on balance, fall risk, and basophobia among post-stroke older adults.

This randomized controlled trial will be conducted at Allama Iqbal Memorial Teaching Hospital Sialkot over six months. The sample size will consist of 51 participants. Participants who meet the inclusion criteria will be taken through a non-probability convenience sampling technique, which will further be randomized through flip coin method. 17 Participants will be assigned to group A (otago exercise, systematic desensitization and routine physical therapy, 17 participants to group B( Otago Exercises and Routine Physical therapy ) and 17 participants were included in group C ( Systematic desensitization and Routine physical therapy only ).

Data will be collected using various assessment tools, including the Berg Balance Scale to assess balance , Timed up and go test for dynamic balance, Functional Reach Test for static balance, Fall Risk assessment scale to assess risk of fall, Fall Efficacy Scale International for risk of fall, and Fear of fall avoidance behavior questionnaire for basophobia. Pre-intervention assessments will be conducted for all three groups. The effects of the interventions will be measured at pre-treatment, 4th week, and post-intervention. Data analysis will be performed by using SPSS 26 software.

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 (Participant)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Both male and female patients
  • •40 to 70 Years of age
  • •sub-acute ischemic stroke
  • •Ability to walk with or without a caregiver
  • •No cognitive dysfunction that would hinder understanding of the instructions
  • •MoCA score between 18-24

排除标准

  • •Patients previous participation in studies similar to the present study.
  • •Participants who have other medical conditions such as severe arthritis or joint injuries.
  • •Participants who have a history of significant neurological or psychiatric disorders
  • •Participants who have severe visual or hearing impairments
  • •Participants who are currently participating in another clinical trial or research study

研究组 & 干预措施

Otago Exercises and systematic desensitization with routine physical therapy

Experimental

Group A emphasizes a combination of Otago exercises and systematic desensitization alongside routine physical therapy. The session begins with a 5-minute warm-up, followed by 7 minutes of Otago balance exercises and 8 minutes of Otago strength exercises. This is complemented by 15 minutes of routine physical therapy focusing on strength and mobility, 5 minutes of flexibility and stretching, and 7 minutes dedicated to relaxation training. The session concludes with 10 minutes of gradual exposure and visualization exercises, allowing participants to mentally navigate safe environments and mildly fear-inducing situations, followed by a 3-minute discussion and feedback segment.

干预措施: Otago exercises and systematic desensitization with routine physical therapy (Other)

Otago Exercises and Routine Physical Therapy

Experimental

Group B, centers solely on Otago exercises integrated with routine physical therapy. This group starts with a 10-minute warm-up, followed by 10 minutes of Otago balance exercises and another 10 minutes for Otago strength exercises. The session continues with 20 minutes of routine physical therapy focused on strength and mobility, concluding with 10 minutes dedicated to flexibility and stretching exercises.

干预措施: Otago Exercises and Routine physical Therapy (Other)

Systematic desensitization and Routine physical therapy

Experimental

Group C combines systematic desensitization with routine physical therapy. The session begins with a 5-minute warm-up, followed by 20 minutes of strength and mobility exercises, and 5 minutes of flexibility and stretching. Participants then engage in 10 minutes of relaxation training, which includes reviewing goals and practicing deep breathing exercises. The session further incorporates 15 minutes of gradual exposure and visualization, allowing participants to confront their fears in a controlled manner, and wraps up with a 5-minute discussion and feedback period.

干预措施: Systematic desensitization and routine physical therapy (Other)

结局指标

主要结局

Fall Risk Assessment Scale

时间窗: 8 weeks

It is a 4-item falls-risk screening tool for sub-acute and residential care. The FRAT has three sections: Part 1 - Fall Risks, Part 2 -Risk factor checklist, Part 3 :Action Plan. A score of 0 to 5 indicates a low risk of falling, a score of 6 to 20 a medium risk, and a score 21 to 45 a high risk.

Berg Balance Scale

时间窗: 8 weeks

The Berg Balance Scale (BBS) is a clinical tool used to assess balance and risk of falling. It consists of 14 simple tasks, such as standing, sitting, and reaching, each scored on a scale of 0 to 4. The total score helps determine the level of balance impairment.

Fall Efficacy Scale International

时间窗: 8 weeks

The Falls Efficacy Scale International (FES-I) is a measure of fear of falling. It is a 16 item questionnaire, useful to the researchers and clinicians interested in fear of falling, with a score ranging from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling).

次要结局

  • Timed Up and Go test(8 weeks)
  • Functional Reach Test(8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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