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临床试验/CTRI/2025/08/092187
CTRI/2025/08/092187尚未招募不适用

Development and application of a novel electromyographic-driven multi-channel functional electrical stimulation for the management of homolateral limb synkinesis during post-stroke gait

Kasturba Medical College Mangalore, MAHE, Manipal3 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2026年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
28
试验地点
3
主要终点
Surface eletromyography, OpenCap, gyroscopes (two), Associated Reaction Rating Scale

研究概览

简要总结

Stroke often leads to various movement impairments, including upper limb Associated Reactions (ARs) during walking. ARs are defined as automatic activities which fix or alter the posture of a part or parts when some other part of the body is brought into action by either voluntary effort or reflex stimulation. Homolateral limb synkinesis (HLS) is considered a type of non-purposive AR and refers to the involuntary movement of the limb on the same side of the body when the corresponding unilateral limb performs a voluntary movement. HLS can negatively impact various aspects of functioning, such as walking, dynamic balance, upper limb movement, activities of daily living, and self-esteem. Additionally, keeping the paretic arm in a fixed position for prolonged periods can contribute to muscular tightness and hinder balance reactions in both the upper and lower limbs, ultimately compromising overall stability. Uncertainty about the key underlying impairments has resulted in a variety of treatment approaches for HLS, many of which are not evidence based.Functional Electrical Stimulation (FES) has become an increasingly prevalent therapeutic technique in stroke rehabilitation, aimed at restoring physical movement in stroke patients with motor impairments. Although a previous study has explored the effects of FES in improving arm swing in stroke patients, it incorporated a small sample size of three patients and delivered the FES only to triceps muscle of the affected upper limb using a preset intensity. Hence this before-after study aims to develop a multi-channel electromyographic (EMG) driven FES and to find out its effectiveness in reducing HLS during gait in post-stroke patients.

The study hypothesizes that the EMG driven FES device will aid in the reduction of HLS during gait in post-stroke patients.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Day(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed sub-acute (15 to 180 days) or chronic (more than 180 days) medically stable post stroke patients
  • Ability to ambulate 10m without assistance
  • HLS in the upper limb with a modal Associated Reaction Rating Scale score of more than or equal to 1.

排除标准

  • Presence of other neurological or neurobehavioral or orthopedic or cardiopulmonary conditions that could affect upper limb or gait
  • Presence of contracture in the affected upper limb
  • Patients who have received baclofen or botulinum toxin treatment within 3 months prior to the day of screening
  • Patients with cognitive impairments (Saint Louis University Mental Scale less than or equal to 26 in patients with a high school education, and less than or equal to 24 in patients who do not have a high school education)
  • Patients with complete sensory loss in the affected upper limb
  • Any active dermatological conditions that could prevent the placement of the device over the affected upper limbs.

结局指标

主要结局

Surface eletromyography, OpenCap, gyroscopes (two), Associated Reaction Rating Scale

时间窗: 0,4,8,12 weeks

次要结局

  • Stroke Rehabilitation Assessment of Movement (STREAM), 10m walk test(0,4,8,12 weeks)

研究者

发起方
Kasturba Medical College Mangalore, MAHE, Manipal
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Manisha Nayak

Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal

研究点 (3)

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