The Feasibility and Impact of A Home-Based NMES Program on Post-Stroke Lower Limb Spasticity
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Retention Rate
研究概览
简要总结
Spasticity is a common complication post stroke. Post-stroke spasticity along with weakness and lack of coordination result in gait abnormalities and functional limitations. Recent treatment option include neuromuscular electric stimulation (NMES), a form of therapy that applies electrical currents to produce contraction of innervated muscle by depolarizing local motor nerves. Currently, there are wide varieties of NMES devices available commercially for consumer.
The main purpose of this study is to evaluate the feasibility and acceptability of a home-based NMES program on lower limb spasticity in patient with post-stroke more than 6 months and to assess the impact of the program. This is single arm prospective intervention study. Patient will apply home-based NMES on their leg for 20 minutes, 5 days a week for 4 weeks. At the end of the study, an outcome measures will be assessed and patient will be required to answer a questionnaires on their experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Post stroke (hemorrhagic or ischemic) with ankle plantarflexor (gastrocnemius and soleus) spasticity MAS 1+ to MAS 3,
- •Post stroke more than 6 months,
- •At least 18 years old,
- •Able to ambulate 10 meter either independently or aided (single point stick or quadripod)
- •Compliant to outpatient therapy.
- •Minimal cognitive (MMSE> 24) and minimal sensory impairment,
- •Stable neurological and medical condition
排除标准
- •Introduction or changes in anti-spastic medication dose within 3 months or during study period,
- •Receiving intervention for spasticity (eg BoNT or serial casting) within 3 months or during research period,
- •New neurological condition/disease,
- •Presence of contraindications to NMES, which is: Pregnancy, Malignancy, Presence of electronic implant eg cardiac pacemaker, cardioverter defibrillator, Uncontrolled seizure/epilepsy, Infected tissues/ tuberculosis or osteomyelitis, Impaired lower limb circulation/ DVT/ thrombophlebitis, Recent fracture or osteoporosis, Actively bleeding tissue or person with untreated hemorrhagic disorder, Damaged or skin diseases at the affected lower limb
研究组 & 干预措施
Home-based Electrical Stimulation Program for lower limb spasticity
Single arm prospective intervention study to assess the feasibility and impact of a home-based program. Patient will apply home-based NMES on their leg for 20 minutes, 5 days a week for 4 weeks. At the end of the study, an outcome measures will be assessed and patient will be required to answer a questionnaires on their experience.
干预措施: Feasibility and Impact of Home-based Electrical Stimulation Program (Other)
结局指标
主要结局
Retention Rate
时间窗: 4 weeks
The proportion of patients who completed the program. Patient completed divided with patient recruited, expressed in percentage (%).
Acceptability
时间窗: 4 weeks
Acceptability as evaluated at the end of the intervention by brief structured questionnaire developed for this study using 5 point Likert scale with 1 (strongly agree) and 5 (strongly agree).
次要结局
- Clinical measurement of spasticity(4 weeks (pre and post assessment))
- Ankle dorsiflexion muscle strength(4 weeks (pre and post assessment))
- Functional Outcome(4 weeks (pre and post assessment))
研究者
Raja Nabila binti Raja Mohamed Anuar
Doctor, Principal Investigator
University of Malaya