A Home-Based Program of Transcutaneous Electrical Nerve Stimulation and Task-Related Trunk Training Improves Trunk Control in Patients With Stroke: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Trunk Impairment Scale
研究概览
简要总结
The investigators hypothesize that application of electrical stimulation would augment the effects of exercises in patients with stroke. Combined electrical stimulation with exercises for 6 weeks would lead to earlier and greater improvement in motor functions when compared with placebo-stimulation with exercises.
详细描述
Previous studies have shown that repeated sensory inputs from transcutaneous electrical stimulation (TES) could enhance brain plasticity and conical motor output. Home-based rehabilitation is shown to be effective in motor recovery and improvement of functional ability in stroke rehabilitation.
The aim of this study was to develop a home-based rehabilitation program to investigate whether combined electrically induced sensory inputs through TES with task-related trunk training (TRTT) in a home-based program would induce earlier and/or greater improvement in, seated reaching distance and trunk control when compared with placebo TES and TRTT, or control with no active treatment in subjects with chronic stroke.
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
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis with first stroke for more than 6 months
- •Discharge from all rehabilitation services
- •Ability to understand and follow commands
- •A carer able for helping the home program
- •No contraindication to assessment protocol and training
排除标准
- •Cognitive disorder with Abbreviated Mental Test less than 7
- •Unilateral neglect with Star cancellation Test less than 47
- •Sensory deficit
- •Unable to give informed consent
- •Unable to speak either Cantonese or English or Mandarin
- •Commodity that preclude them from undergoing training and assessment
- •Neurological disease other than stroke
研究组 & 干预措施
electrical stimulation with exercises
The TENS + TRTT group received TENS simultaneously with the TRTT at home under the instruction of a physical therapist.
干预措施: electrical stimulation with exercises (Behavioral)
placebo stimulation with exercises
The TENS + TRTT group received placebo-simultaneously with the TRTT at home under the instruction of a physical therapist.
干预措施: placebo stimulation with exercises (Behavioral)
Control
Subjects in this group did not receive any active training. Home safety advice and health education including diet control and blood pressure monitoring were given to the subjects during the home-visit and telephone follow-up.
结局指标
主要结局
Trunk Impairment Scale
时间窗: baseline, 6 weeks
The Trunk impairment scale is a 2 to 4-point ordinal scale. The scale assesses static and dynamic sitting balance and trunk coordination. The maximum scores on the static sitting balance, dynamic sitting balance, and coordination subscales are 7, 10, and 6 points, respectively. The total score of Trunk impairment scale ranges between 0 and 23 points, with a higher score representing better trunk control. The static sitting balance subscale evaluated the trunk stability with both feet on the floor and with the legs crossed. The dynamic sitting balance subscale evaluated the ability to perform trunk side flexion. The coordination components evaluated the ability to selectively rotate the upper and lower parts of the trunk.
次要结局
- Forward Sitting Functional Reach Test(baseline, 6 weeks)
研究者
Shamay Ng
Associate Professor
The Hong Kong Polytechnic University