Effects of forward reach on paretic lower extremity muscles of patients with stroke in a modified sitting position
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- CHANGES IN MUSCLE RECRUITMENT FOR THE TIBIALIS ANTERIOR AND QUADRICEPS MEASURED BY SURFACE ELECTROMYOGRAPHY (EMG) AT THE END OF INTERVENTIONS
研究概览
简要总结
Study Procedure
The study will be conducted in four steps:
Step 1 – screening of the stroke patients in the wards for the inclusion criteria and briefly explain the study and obtaining the consent from participants.
All patient with stroke will be screened for inclusion to the study from neurology department of SRMC. Explain and demonstrate rehabilitation program that incorporates forward reaching at distance of one and half of the arm length, with only paretic limb supported in experimental group and both lower limbs supported in control group will be to those who qualifies for the study followed by obtaining their consent for voluntary participation.
Step 2 – randomization and baseline data collection.
The subjects will be recruited randomly for the study based on inclusion and exclusion criteria.
They will be randomly sampled and concealment allocation to experimental and control group.
Participants who provide consent will be explained about the study and exercise protocolfor sEMG.
Baseline data will be collected by blinded assessor on participants’ demographics, muscle recruitment patterns, including average amplitude of muscle contraction for the tibialis anterior and quadriceps on paretic lower limb.
Step 3 – Implementation and Monitoring
Appropriate training will be provided to participants regarding the forward reach exercise program. 20 repetitions per sessions will be done under therapist’s supervision. Exercise will be conducted twice per day for 8 days.
The surface EMG electrodes will be attached to the tibialis anterior and quadriceps on the paretic limb following standard SENIAM EMG electrode placement guidelines. EMG recording equipment will be started to collect data during the exercise. Safety monitoring and feasibility will be included in the study.
Post intervention assessment will be conducted at the end of 8 days of the study.
Step 4 – Data analysis
The collected data will be stored safe in computer with password and interpreted using statistical analysis,
Repeated Measures Analysis of Variance (ANOVA) will be used to assess changes over time from pre-intervention to post-intervention within each group and compare these changes between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Confirmed diagnosis of stroke within the acute phase in MCA territory, as determined by medical records and clinical assessment.
- •2.Participants with the age between 18 and 75 years.
- •3.Participants with a stable medical condition that allows for participation in the study and the prescribed exercise regimen.
- •4.Ability to sit for at least 30 seconds, understand and follow instructions related to the supported sitting reaching tasks.
- •5.Lower limb Brunnstrom score of at least 2.
排除标准
- •1.Patients with co-existing (premorbid and comorbid) neurological conditions other than stroke were excluded.
- •2.Individuals with severe cognitive impairments that prevent them from understanding and following task instructions were excluded.
- •3.Patients with severe medical complications that contraindicate participation in physical exercises, such as uncontrolled hypertension or cardiovascular instability, were excluded.
- •4.Individuals with mobility limitations or impairments unrelated to stroke that significantly affect their ability to perform the prescribed exercises were excluded.
- •5.Patients who do not provide informed consent to participate in the study were excluded.
结局指标
主要结局
CHANGES IN MUSCLE RECRUITMENT FOR THE TIBIALIS ANTERIOR AND QUADRICEPS MEASURED BY SURFACE ELECTROMYOGRAPHY (EMG) AT THE END OF INTERVENTIONS
时间窗: 8 days
次要结局
未报告次要终点
研究者
Nuwagi Buay Tluway
Sri Ramachandra Institute of Higher Education and Research