Effectiveness of Transcutaneous Electrical Nerve Stimulation Combined With Task-Related Training on Upper Limb Function in Subacute Hemiparetic Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment of upper extremity scores (FMA-UE)
研究概览
简要总结
To study the effectiveness of transcutaneous electrical nerve stimulation (TENS) combined with occupational therapy on restoring the function of the weakened limb in subacute stroke patients.
详细描述
To study the effectiveness of transcutaneous electrical nerve stimulation (TENS) combined with occupational therapy on restoring the function of the weakened limb in subacute stroke patients.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with a first-ever stroke, presenting with unilateral weakness and accompanying arm weakness, in the subacute phase (2 weeks - 6 months).
- •Able to follow commands and cooperate in an active training program.
- •Patients must consent to participate in the research project by signing a consent form.
- •Aged between 18 and 80 years.
- •Exhibiting mild to moderate muscle spasticity (Modified Ashworth Scale < 3).
排除标准
- •Patients with other neurological disorders, such as traumatic brain injury or spinal cord injury, or those experiencing severe complications from treatment.
- •Unable to tolerate the use of TENS.
- •Contraindications for using TENS, such as having a pacemaker or infected skin lesions.
- •Unstable or uncontrolled vital signs or other comorbidities.
- •Communication difficulties that prevent following commands or cooperating in training.
- •Participants who refuse or withdraw from the research.
研究组 & 干预措施
TENS
Transcutaneous Electrical Nerve Stimulation (TENS) was applied to the brachial plexus at the supraclavicular fossa (Erb's point) and to the radial nerve between the biceps and triceps in the spiral groove. The frequency was set at 10 Hz, and the intensity was adjusted to a level that elicited sensation without causing pain or muscle twitching, for a duration of 45 minutes, five days a week, totaling 20 sessions over four weeks, combined with standard upper extremity conservative occupational therapy training.
干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Device)
Sham TENS
Transcutaneous Electrical Nerve Stimulation (TENS) on the affected arm according to the same treatment protocol as above; however, the device was not turned on, and no electrical current was delivered (Placebo).
干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Device)
结局指标
主要结局
Fugl-Meyer Assessment of upper extremity scores (FMA-UE)
时间窗: baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia
次要结局
- Wolf motor function test (WMFT)(baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.)
- Box and block test (BBT)(baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.)
- Modified functional reach test (FRT)(baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.)
研究者
Songsuda Roongsaiwatana
Principal Investigator
Mahidol University