Development and Testing of Neuro-Rehabilitation Strategies for improving Hand Functions beyond Brunnstrom Stage II in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Spasticity,Cognitive status,Grip strength,Pinch strength,Hand function,Co-activation, muscle activation,Disability,Fine motor skills,Finger dexterity
研究概览
简要总结
Stroke patients who met the inclusion and exclusion criteria will be selected for the study and will then be asked to sign a consent form. After signing the informed consent, stroke patients will be assigned to experimental and control group. Baseline measurement including Mini mental state examination (MMSE), demographic data etc. will be done to allow for more in-depth description of the participant’s impairment. The experimental group will receive the developed intervention and control group will receive conventional physiotherapy. All outcome measures will be recorded at the baseline assessment, and after every two week of intervention and at the end on completion of intervention.
Randomization will be performed using computer generated randomization table with a 1:1 ratio by a statistician not involved in the study. Subjects will be blinded to the groups will be allocated to Neuro-rehabilitation strategies group (Experimental Group) and conventional intervention group (Control Group). Group allocations will be assigned through sealed opaque envelopes. The envelopes will be kept in a closet by independent researcher who are not involved in the study.
Experimental group will receive developed neurorehabilitation strategies and conventional physiotherapy that will be given to control group includes range of motion, stretching and strengthening exercises of upper limb.
The duration of the study will be 12 weeks as most of the improvement in hand function occurs in between 8 weeks to 32 week. The dosage will be 45 mins, 5 days per week, at 50-80 % of maximum Heart Rate. This 45 mins session will include 5-10 min of warm-up and cool-down.
Outcome measures will be evaluated at baseline, 6th and at the end of 12th week of intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with acute episode of stroke
- •Patient with Middle Cerebral Artery (MCA) involvement
- •Patients having haemorrhagic or non-haemorrhagic stroke
- •Patients who were in stage III in Brunnstrom hand recovery scale.
- •Mini mental State Examination Scale (MMSE) Score equal to or greater than 24 6.
排除标准
- •Patients having a history of prior stroke involving other hemisphere
- •Patients having poor cognitive function and aphasia
- •Patients having visual ,hearing deficit and perceptual deficit
- •Patients having emotional changes such as emotional lability, indifference, euphoria, anosoagnosia
- •Patients having secondary deformation due to musculoskeletal disease in hand
- •Patient having musculoskeletal disorder affecting shoulder.
- •Pain with VAS score greater than 4
- •Patients having uncontrolled diabetes and hypertension.
- •Patient having any other neurological disorder except stroke Demyelinating and Degenerative diseases of brain such as myelopathy ,myopathy, traumatic head injury, intracranial tumour
- •Arthritis
- •Acute Respiratory Distress Syndrome
- •Patient with Myocardial Infaction ,stable angina
- •Patient having pacemaker or any other metal implant in body
- •Pregnancy
- •Uncontrolled epilepsy 16.
结局指标
主要结局
Spasticity,Cognitive status,Grip strength,Pinch strength,Hand function,Co-activation, muscle activation,Disability,Fine motor skills,Finger dexterity
时间窗: Outcome measures will be evaluated at baseline, 6th and at the end of 12th week of intervention
次要结局
- Stroke Motor Recovery Scale,Disability,Recovery of Motor Impairment,Disability,Lifestyle after stroke(Outcome measures will be evaluated at baseline, 6th and at the end of 12th week of intervention)