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临床试验/NCT07328867
NCT07328867已完成不适用

Combined Effects of Dual-task and Perturbation Based Training on Balance and Cognition in Stroke Patients

Foundation University Islamabad1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2025年6月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
1
主要终点
Balance

研究概览

简要总结

This study aims to evaluate the Combined Effects of Dual-task and Perturbation Baesd Training on Balance and Cognition in Stroke Patients. Stroke is an acute cerebrovascular disorder that can impair cognitive, motor, and balanace abilites. Stroke is the second largest cause of death and disability globally. According tp studies, people who have had a stroke are more likely to fall than others who are same age and gender. PBBT is known as artificially induced balance training technique that can mimics the loss of balance that can occur naturally in freal life. Reduction in falls has been reported broadly by the use of perturbation based balance training. Current study will be and RCT on 33 participants based on the inclusion critieria. Participants will be randomly and equally divided into two groups; group B receiving Perturbation Based Training Alone and Group A receiving Dual-task and Perturbation Based Balance Training. The treatment will be given for 40 minutes, 3 days a week for 6 consecutive weeks. The assessment will be conducted at baseline, for cognition by Montreal Cognitive Assessment Scale (MoCA), for initial treadmill speed 10 Meter Walk Test (10MWT), for balance by Berg Balance Scale (BBS), and for fall riak by Fall Efficacy Scale (FES). Final assessment will be conducted after 6 weeks.

详细描述

Stroke is a multifaceted disease that can be caused by a variety of risk factors, disease processes and causes. Stroke results in the change of cognitive function, which effects resulting in minor impairment to the development of post-stroke dementia. The cognitive deficiencies in a stroke survivors have significant influence on their daily productivity. In addition, falls are a prevalent and potentially fatal issue for as many as 47% of all stroke patients admitted to the hospital.Some studies suggest that Dual-task training when paired with mechanical action of treadmill could maximize the constraint on the cognitive control processes for gait.

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
None

入排标准

年龄范围
25 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • No limitation of genders.
  • Age between 25-80 years
  • Participants diagnosed with chronic stroke
  • Participants being able to walk with or without walking aid independently or under supervision
  • Participants with impaired balance as indicated by a score of <=41 on BBS
  • Participants with Montreal Cognitive Assessment Score <26

排除标准

  • Patient with sinificant co morbidties or secondary complications including orthopedic or rheumatological disorders were excluded
  • Patients with severe cognitive impairment or dementia
  • Apraxia or hemi-neglect
  • Participants with body weight >100kg
  • Participants with significant visual or hearing impairments
  • Patients with epilepsy or pacemaker
  • Participants with peripheral or central neuropathies that could impair balance

研究组 & 干预措施

Dual-task and Perturbation Based Training

Experimental
  1. Participants in the experimental group received combined perturbation and dual task training
  2. The intervention was conducted for 3 days a week for 6 consecutive weeks
  3. Each treatment session lasted approximately 40 minutes including 5 minute of warmup and 2 minutes of rest between 2 segments
  4. Primary training modality was treadmill
  5. Initial walking speed was determined individually for each participant by using 10MWT
  6. Perturbations were applied manually during treadmill walking
  7. The intensity of treadmill was progressively increased across sessions by change in directions of perturbations, unpredictability, walking speed and reducing hand support when safe
  8. Dual-task training is added after 3 session and will be performed concurrently with perturbation training.
  9. Cognitive tasks include counting backwards, naming animals, subtracting 3 from 100.
  10. The complexity of the task will progressively increased
  11. Safety should be ensured by using the harness

干预措施: Perturbation + Dual-Task Training (Procedure)

Perturbation Based Training

Active Comparator
  1. Participants in control group received Perturbation Baesd Training Alone
  2. The intervention was conducted for 3 days a week for 6 consecutive weeks
  3. Each treatment session lasted 40 minutes including 5 minute of warm up and 2 minute of rest between segments
  4. Primary training modality was treadmill
  5. Initial walking speed was determined individually for each participant by using 10MWT
  6. Perturbations were appllied manually during treadmill walking
  7. The intensity of treadmill was progressively increased across sessions by chanfe in directions of perturbations, unpredictability, walking speed and reducing hand support when safe
  8. Safety should be ensured by using the harness, keeping emergency stop at reach, and use of handrails when necessary

干预措施: Perturbation-Based Training (Procedure)

结局指标

主要结局

Balance

时间窗: 6 weeks

Berg Balance Scale (BBS) was used, Maximum Total=56 points (41-56=Low fall risk, 21-40= Medium fall risk, 0-20 High fall risk)

Cognition

时间窗: 6 weeks

Montreal Cognitive Assessment Scale, Maximum score=30 (26-30= normal cognition, 18-25= mild cognitive impairment, 10-17 moderate cognitive Impairment, \<10=severe cognitive impairment

次要结局

  • Fall Risk(6 Weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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