Neuromuscular Electrical Stimulation and Voluntary Muscle Contraction in Chronic Hemiplegic Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Modified Ashworth scale
研究概览
简要总结
This single-blinded randomized controlled trial will be conducted at the Physical Therapy Department of the University of Lahore Teaching Hospital after approval from the Institute Research Ethics Board. Eligible participants will be recruited and randomly allocated into two groups by lottery method: Group A (control group) receiving conventional physical therapy, and Group B (experimental group) receiving neuromuscular electrical stimulation (NEMS) combined with voluntary muscle contraction. NEMS will be applied to the tibialis anterior, extensor hallucis longus, and extensor digitorum longus with standard stimulation parameters, while participants perform active dorsiflexion during stimulation. The assessor will remain blinded to group allocation. Outcome measures including spasticity (Modified Ashworth Scale), active range of motion (goniometer), and muscle strength (manual muscle testing) will be evaluated at baseline, 6 weeks, and 12 weeks.
详细描述
Recruitment: Participants will be recruited from Physical Therapy Department of University of Lahore Teaching Hospital, Lahore Screening: All the referred participants will be assessed for the eligibility criteria.
Patients fulfilling the eligibility criteria will be asked to sign the consent forms before entering them to the study. Randomization and Allocation: All the screened and willing participants will be randomly allocated to two groups (Group A: Experimental group/NEMS + voluntary muscle contraction group. Group B: control group/standard rehabilitation therapy) by lottery method. Blinding: This study was a single blinded study in which assessor was kept blinded Intervention Group A: Comparative Group (Conventional physical therapy) Patients in comparative group will receive conventional approach that will encompass placebo effect application of NEMS, weight bearing , stretching , pnf technique , tapping , passive roms , strength exercise of dorsiflexors Group B : Experiment Group/NEMS+Voluntary muscle contraction group: The participants randomly allocated in Group A will receive the electrical stimulation through electrodes on tibialis anterior, extensor hallucis longus and extensor digitorum longus
.Stimulation parameters will be as follows: pulse width=200 microseconds; on time=5seconds; off time=5seconds; frequency=20Hz; waveform=symmetrical biphasic square wave. The patient will be instructed to produce a voluntary dorsi flexors contraction with the electric pulse The stimulation intensity will adjusted according to each treatment group. All intensities were comfortable for the patients and did not induce fatigue. Any complaints and discomfort during the treatment process in each group will monitored and recorded using a patient record.
Outcome Variables:
- Spasticity: Modified Ashworth scale
- Active rom: Goniometer
- Muscle Grading: Manual muscle testing Data will be assessed by assessor at baseline, at the end of 6th week and at the end of 12th week
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)
盲法说明
Study will be single and assessor blinded. Participants will be masked about other groups but they will know what treatment they will be receiving or what exercises they will be doing. Principal investigator would also not be masked or blinded because investigator would be applying the techniques on participants of both group. So participant and and principal investigator cannot be blinded. Only assessor will be blinded and he will take outcome measures without knowing the problem and treatment techniques.
入排标准
- 年龄范围
- 43 Years 至 83 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of between 43 to 83 years of age
- •Diagnosed with chronic stroke (≥6 months in duration) with motor deficits resulting in hemiplegia
- •Mild ankle dorsiflexion possible
- •MAS score of ≤3 for dorsiflexors to the ankle joint
- •Be self-mobility either with or without aids .
排除标准
- •Parkinson's or multiple sclerosis affecting the nervous systems of the body
- •Skeletal disorders that hinder the ability of the limb
- •Pacemaker or any condition which may lead to a contraindication with NMES
- •Spasticity (MAS ≥ 3)
- •Current botulinum toxin injections in the lower limb that developed the spasticity
- •Patients with any cognitive impairment (MMSE < 24)
研究组 & 干预措施
Conventional physiotherapy
Conventional physiotherapy Participants in the comparative group will receive conventional physiotherapy treatment including placebo application of neuromuscular electrical stimulation (NEMS), weight-bearing exercises, stretching, proprioceptive neuromuscular facilitation (PNF) techniques, tapping, passive range of motion (PROM) exercises, and dorsiflexor strengthening exercises. The placebo NEMS will be applied in the same manner as the active stimulation but without any therapeutic current. Each session will be supervised by a physiotherapist. Treatment will be conducted as per the study protocol, and all participants' responses, complaints, and discomforts during the sessions will be monitored and recorded using a patient record sheet.
干预措施: Conventional physiotherapy (Other)
Conventional physiotherapy
Conventional physiotherapy Participants in the comparative group will receive conventional physiotherapy treatment including placebo application of neuromuscular electrical stimulation (NEMS), weight-bearing exercises, stretching, proprioceptive neuromuscular facilitation (PNF) techniques, tapping, passive range of motion (PROM) exercises, and dorsiflexor strengthening exercises. The placebo NEMS will be applied in the same manner as the active stimulation but without any therapeutic current. Each session will be supervised by a physiotherapist. Treatment will be conducted as per the study protocol, and all participants' responses, complaints, and discomforts during the sessions will be monitored and recorded using a patient record sheet.
干预措施: Neuromuscular electrical stimulation and voluntary muscle contraction (Other)
Neuromuscular electrical stimulation + Voluntary muscle contraction
Experimental Group (NEMS + Voluntary Muscle Contraction) Neuromuscular Electrical Stimulation (NEMS) with Voluntary Muscle Contraction Participants in the experimental group will receive neuromuscular electrical stimulation (NEMS) combined with voluntary muscle contraction of the dorsiflexors. Surface electrodes will be placed over the tibialis anterior, extensor hallucis longus, and extensor digitorum longus muscles. Stimulation parameters will be set as follows: pulse width = 200 microseconds, on time = 5 seconds, off time = 5 seconds, frequency = 20 Hz, waveform = symmetrical biphasic square wave. Participants will be instructed to voluntarily contract the dorsiflexors during each stimulation pulse. The stimulation intensity will be adjusted according to patient comfort to avoid fatigue. Each session will be administered by a trained physiotherapist following the standardized protocol. Any discomfort or adverse response during the procedure will be documented in the patient
干预措施: Conventional physiotherapy (Other)
Neuromuscular electrical stimulation + Voluntary muscle contraction
Experimental Group (NEMS + Voluntary Muscle Contraction) Neuromuscular Electrical Stimulation (NEMS) with Voluntary Muscle Contraction Participants in the experimental group will receive neuromuscular electrical stimulation (NEMS) combined with voluntary muscle contraction of the dorsiflexors. Surface electrodes will be placed over the tibialis anterior, extensor hallucis longus, and extensor digitorum longus muscles. Stimulation parameters will be set as follows: pulse width = 200 microseconds, on time = 5 seconds, off time = 5 seconds, frequency = 20 Hz, waveform = symmetrical biphasic square wave. Participants will be instructed to voluntarily contract the dorsiflexors during each stimulation pulse. The stimulation intensity will be adjusted according to patient comfort to avoid fatigue. Each session will be administered by a trained physiotherapist following the standardized protocol. Any discomfort or adverse response during the procedure will be documented in the patient
干预措施: Neuromuscular electrical stimulation and voluntary muscle contraction (Other)
结局指标
主要结局
Modified Ashworth scale
时间窗: 12 weeks
The Modified Ashworth Scale is a clinical tool used to assess muscle spasticity by measuring resistance during passive soft-tissue stretching. It grades the increase in muscle tone on a scale from 0 to 4, where 0 indicates no increase in muscle tone and 4 indicates the affected part is rigid in flexion or extension. It is a widely used and reliable method for evaluating the severity of spasticity in patients with neurological or musculoskeletal conditions.
Goniometery
时间窗: 12 weeks
A goniometer is an instrument that either measures an angle or allows an object to be rotated to a precise angular position.
Manual muscle testing
时间窗: 12 weeks
Manual Muscle Testing is a standardized clinical assessment used to evaluate the strength of individual muscles or muscle groups based on the examiner's application of resistance. Muscle strength is graded on a six-point scale (0-5), where 0 indicates no muscle contraction and 5 represents normal strength against full resistance. It is a reliable and widely used method to assess motor function, recovery, and the effectiveness of therapeutic interventions.
次要结局
未报告次要终点