A Randomized Controlled Trial to Assess the Effectiveness of Functional Electrical Stimulation with Cycling on Motor Performance among Patients with Hemiparetic Middle Cerebral Artery Stroke
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Motor recovery measures
研究概览
简要总结
In our country the stroke population are mostly the bread-winners of their family, so considering that it is important to augment early standing and walking.The short inpatient rehabilitation of the stroke patient with hemiparesis/hemiplegia has to be augmented for better lower limb motor performance and early walking to harness the Neuroplasticity of brain. Recently Functional Electrical Stimulation (FES) is being used to either replace or retrain function. Functional electrical stimulation (FES) can be combined with cycling to generate the active movement of paralyzed muscles.The use of an FES approach in the early phase of stroke rehabilitation for therapeutic purposes facilitates the achievement of better functional output in a shorter period of time. An electrical stimulation integrated along with functional activity can significantly increase quadriceps recruitment in persons recovering from stroke. Wandel et al 2000 in their study reported strong relationship between leg motor power after 7 days of stroke and subsequent recovery of gait. They found that post stroke ..individuals who started therapy earlier are more likely to have a better gait recovery.
Research Question
Population- In Patients with Middle Cerebral Artery Stroke who are not able to stand and walk
Intervention-Functional Electrical Stimulation with Cycling
Comparison- Standard post stroke Exercise
Outcome of interest- Motor performance Measures
AIM OF THE STUDY
To determine changes on Motor Performance variables after Functional Electrical Stimulation Cycling(FESC) compared to conventional exercises only among patients with hemiparetic Middle Cerebral Artery Stroke
Medically stable InPatient’s from the KMCH Hospital Diagnosed by the Neurologists as Middle Cerebral Artery Stroke and referred for stroke rehabilitation will be recruited for the study. Patients who fulfill the selection criteria and showing willingness to participate in the study after providing Informed consent will be selected. Pretest measures will be taken prior to the interventions . The selected patients will be randomly allocated to 30 in each group.
– FES Cycling (Experimental Group)
– Conventional Exercises (Standard therapeutic and task based exercises) (Control Group)
After Baseline Measures are taken the Exercise Protocol will be implemented for 3 Weeks. Post Test(T1) will be measured after 3 weeks with the set of selected motor performance measures.
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
- 45.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Inpatients who are clinically diagnosed with Middle Cerebral Artery Stroke and referred for post stroke rehabilitation 2.Both males and females in age group 45-70 years.
- •3.Stroke of duration within first to third week.
- •4.Both Ischaemic and Haemorrhagic Stroke patients 5.Brunnstrom voluntary stage II and 1V for affected lower limb 6.Able to sit with support and not an independent ambulator 7.Spasticity in Quadriceps and Hamstrings less than 2 according to Modified Ashworth Scale .
- •8.Able to understand and follow commands 9.Adequate sensory function to understand perception of current and cycling.
- •10.Cooperative and willing to participate in this study.
排除标准
- •1.Recurrent stroke, Patients with Hemi spatial neglect or Pushers syndrome.
- •2.Contraindications for lower limb mobilization like DVT 3.History of any other musculoskeletal problems of lower limb and limited passive joint range of motion which will hinder the interventions and exercise 4.Patients with implants such as pace makers, metal implants over affected lower limb ,skin lesions over stimulation site, Sensory disturbances over the dorsal or ventral aspect of thigh.
- •5.Patients with any other Neurological disorders.
- •6.Global aphasia and Receptive dysphasia.
- •7.Medically unstable Eg: Uncontrolled Cardiac arrhythmias.
- •reduced cardiac output, Postural hypotension.
结局指标
主要结局
Motor recovery measures
时间窗: Baseline /Pre test- 0 weeks | Post Test -After 15 sessions of training 3rd week | Follow up - 6th week
1.Fugl-Meyer Assessment Scale Lower Limb Component -For Motor performance (Scores)
时间窗: Baseline /Pre test- 0 weeks | Post Test -After 15 sessions of training 3rd week | Follow up - 6th week
2.Functional Ambulation Category-Walking Performance(Scoring)
时间窗: Baseline /Pre test- 0 weeks | Post Test -After 15 sessions of training 3rd week | Follow up - 6th week
3.Five Times Sit to Stand Test - for lower limb functional strength (Timed in seconds)
时间窗: Baseline /Pre test- 0 weeks | Post Test -After 15 sessions of training 3rd week | Follow up - 6th week
4.Upright Motor Control Test -Voluntary control of affected lower limb (Scoring)
时间窗: Baseline /Pre test- 0 weeks | Post Test -After 15 sessions of training 3rd week | Follow up - 6th week
次要结局
- Gait speed(6th week for ambulatory persons)
研究者
Brammatha A
Phd Scholar under The Tamilnadu Dr M G R Medical University, Centre RVS College of Physiotherapy