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临床试验/NCT02753322
NCT02753322Unknown不适用

Training Dual-task Balance and Walking in People With Stroke: a Randomized Controlled Trial

The Queen Elizabeth Hospital1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2016年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
84
试验地点
1
主要终点
Degree of the dual-task interference

研究概览

简要总结

Stroke is one of the most common chronic disabling conditions in Hong Kong. People after stroke may suffer from certain degree of physical impairment and disability. Resuming safe ambulation in the community appears to be a big challenge to them as it always involves the simultaneous performance of two or more tasks (dual task) such as walking and talking with someone, walking and recalling the shopping list etc. Numerous studies has demonstrated that the interference from dual tasks (dual task interference) may significantly impact the recovery of the functional walking. To date, the relevance of dual task walking to daily community is widely documented and the ability of managing dual task is therefore particularly important. Evidences supported that dual task training showed its promising effect on the balance and walking performance amongst people with neurological disorders, such as chronic stroke. In light of this, the introduction of dual task based balance and walking training into physiotherapy program for stroke patient may enhance the balance and walking performance and hence promote successful community ambulation. Yet, there is limited evidence on its effect in sub-acute stroke.

Objective: To examine the effectiveness of a dual-task based balance and walking training program on performance and dual task interference in balance and walking ability, balance self-efficacy and incidence of falls in people with sub-acute stroke

详细描述

An assessor-blind, randomized control trial will be conducted. Eighty-four people with sub-acute stroke and fulfill the eligibility criteria will be recruited from the medical wards of the Queen Elizabeth Hospital (QEH) or from the Physiotherapy Department of the QEH. Subjects will be randomly allocated into either dual-task training (DT) group (n=28) or single-task training (ST) group (n=28) or Control (C) group (n=28) by 1:1:1 randomization sequence after baseline evaluation. All subjects will receive usual physiotherapy training. Subjects in the DT group will undergo 30 minutes of dual task training with simultaneously performing balance and walking exercise and attention demanding tasks, and 30 minutes of stretching exercises whereas those in the ST group will undergo single task training with 30 minutes of balance and walking exercise and 30 minutes of attention demanding task performed separately. Subjects in the control group will receive stretching and strengthening exercise only. The training program will last for 8 weeks with frequency of 2 sessions a week and duration of 60 minutes per session.

The degree of the dual-task interference, the balance and walking performance in dual task conditions will be evaluated at three time points: (1) Baseline (within one week before the intervention (2) within one week after completion of training (3) 8 weeks after the completion of training by blinded assessors. Also, the subjects will have monthly telephone follow up on the fall incidence for 6 months after completion of the program.

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)

入排标准

年龄范围
50 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of a stroke confirmed by the individual's physician, between 1 month and 6 months post-stroke onset
  • •Community-dwelling prior to stroke onset (defined as living in one's own home or the home of a relative, friend or caregiver)
  • •Medically stable
  • •Montreal Cognitive Assessment (MoCA) scored ≥21
  • •Ability to follow 3-step commands
  • •Having motor impairment in the affected lower extremity [Chedoke McMaster Stroke Assessment (CMSA) leg and foot summative score of 4-13 out of 14)], and upper extremity (CMSA arm and hand summative score of 4-13 out of 14)
  • •Having balance deficits (Mini-Balance Evaluation Systems test score <24)
  • •Able to ambulate without physical assistance of another person as determined during the 10-meter walk test

排除标准

  • •Recurrent stroke
  • •Having neurological conditions other than stroke
  • •significant receptive and expressive aphasia
  • •Severe and uncorrected hearing or visual deficits
  • •Serious musculoskeletal (e.g. amputation) or cardiovascular conditions affecting the ability to exercise (e.g. congestive heart failure), pain experienced at rest or movement, and other serious illnesses that preclude participation.

研究组 & 干预措施

Dual-task training group

Experimental

Subjects in this group will have 30 minutes of dual-task training with simultaneously performing balance and walking exercise and attention demanding tasks, and 30 minutes of stretching exercises.

The training program will last for 8 weeks with frequency of 2 sessions a week.

干预措施: Dual task training (Other)

Single-task training group

Active Comparator

Subjects in this group will have single-task training with 30 minutes of balance and walking exercise and 30 minutes of attention demanding task performed separately.

The training program will last for 8 weeks with frequency of 2 sessions a week.

干预措施: Single-task training (Other)

Limbs exercise group

Active Comparator

Subjects in this group will have stretching and strengthening exercise for 60 minutes.

The training program will last for 8 weeks with frequency of 2 sessions a week.

干预措施: Limbs exercise (Other)

结局指标

主要结局

Degree of the dual-task interference

时间窗: Baseline, 8 weeks, 16 weeks

It will be assessed by calculating the percentage of the difference between single task performance (2 walking tasks and 2 balance tasks) and dual task performance of the 2 walking tasks and 2 balance tasks while engaging in 3 attention demanding tasks.

次要结局

  • Standing balance with eyes closed in dual task conditions(Baseline, 8 weeks, 16 weeks)
  • 10 metre walk test in dual task conditions(Baseline, 8 weeks, 16 weeks)
  • Obstacle crossing test in dual task conditions(Baseline, 8 weeks, 16 weeks)
  • Standing balance with eyes opened in dual task conditions(Baseline, 8 weeks, 16 weeks)
  • Chinese version of Activities-specific Balance Confidence (ABC) Scale(Baseline, 8 weeks, 16 weeks)
  • Chedoke Arm and Hand Activity Inventory (short form)(Baseline, 8 weeks, 16 weeks)
  • Incidence of falls(From baseline to 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

POON Margaret Wai Yee

Senior Physiotherapist

The Queen Elizabeth Hospital

研究点 (1)

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