effects of low-level laser therapy therapeutic ultrasound and electrical stimulation in altering structural and functional outcomes in spinal cord injury population
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- DTI diffuse tensor imaging
研究概览
简要总结
The current study aims to investigate the effect of Low-Level Laser Therapy, therapeutic Ultrasound and Electrical Stimulation along with conventional physiotherapy and to determine whether these interventions lead to any alteration in spinal cord fibers that subsequently influence the functional outcomes of patients with spinal cord injuries.
Totally 45 participants will be included in this study after satisfying the inclusion and exclusion criteria and after obtaining their informed consent.
The study is divided into three interventional group:
First interventional group will recieve low level laser therapy 5 settings per week for 12 weeks with a duration of 10 minutes for each session and dosage 2-4J/cm2 along with conventional physiotherapy intervention includes Cardio Respiratory Exercises In-bed Mobilization MAT Activity Tilt Table Standing Task Specific Training Sitting within bed Trunk Stability Exercises Core Strengthening Exercises Upper Limb Strengthening Exercises Prolonged Standing with walker support using proper prosthesis Balance Training Static and Dynamic Sitting to Standing Gait Training in parallel bar.
Second group will recieve therapeutic ultrasound 5 settings per week for 12 weekswith a duration of 10 minutes and dosage 1Mhz with intensity 0.8 W/cm2 along with conventional physiotherapy intervention which includes Cardio Respiratory Exercises In-bed Mobilization MAT Activity Tilt Table Standing Task Specific Training Sitting within bed Trunk Stability Exercises Core Strengthening Exercises Upper Limb Strengthening Exercises Prolonged Standing with walker support using proper prosthesis Balance Training Static and Dynamic Sitting to Standing Gait Training in parallel bar.
Third group will recieve electrical stimulation 5 settings per week for 12 weeks with a duration of 10 minutes and dosage cycle 5/5 with a maximum visual contraction and patient tolerance level along with conventional physiotherapy routine which includes Cardio Respiratory Exercises In-bed Mobilization MAT Activity Tilt Table Standing Task Specific Training Sitting within bed Trunk Stability Exercises Core Strengthening Exercises Upper Limb Strengthening Exercises Prolonged Standing with walker support using proper prosthesis Balance Training Static and Dynamic Sitting to Standing Gait Training in parallel bar.
The outcome measure are:
DTI diffuse tensor imaging, American spinal injury association impairement scale,The spinal cord independence measurement scale SCIM.
The timeline for outcome measures are:
DTI diffuse tensor imaging-Day-0(Before Intervention) and End of 12th week(After the last day)
American spinal injury association impairment scale-Day-0(Before Intervention) and End of 12th week(After the last day)
The spinal cord independence measurement scale SCIM-Day-0(Before Intervention) and End of 12th week(After the last day)
The procured datas will be statistically analysed and disseminatted as Phd Thesis and will be updated in this CTRI portal for the benefit of common public and scientific society.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Spinal Cord Injury Participants must have a documented traumatic or non-traumatic spinal cord injury resulting in neurological deficits by neuro surgeons The level of injury should be between C1 and L5 as assessed by the International Standards for Neurological Classification of Spinal Cord Injury ISNCSCI Time Since Injury Participants should be within a specific time frame since the initial SCI between 3 and 12 months to ensure a similar stage of recovery Age Range Include participants within a defined age range 18 to 50 years to ensure a homogeneous sample Consent and Cooperation Obtain informed consent from potential participants or their legal guardians if necessary Ensure participants are willing and able to cooperate throughout the study attending all required assessments and rehabilitation sessions Medical Stability Participants should be medically stable and free from acute medical conditions that could interfere with rehabilitation or imaging assessments Ability to Undergo Rehabilitation Participants should have sufficient physical and cognitive capabilities to engage in rehabilitation interventions such as LLLT LIPUSTNMES TILT TABLE etc.
排除标准
- •Severe Medical Comorbidities Exclude participants with severe medical conditions uncontrolled cardiovascular disease severe infections head injury with low GCS level that may interfere with the rehabilitation process or pose additional risks Previous Spinal Surgery or Interventions Exclude individuals who have undergone previous spinal surgery or interventions as these may confound the study results Pregnancy Pregnant individuals will be excluded due to potential risks associated with radiation exposure during DTI scans Severe Neurological Conditions Exclude participants with pre-existing severe neurological conditions multiple sclerosis Parkinsons disease that could affect the interpretation of rehabilitation outcomes Non-Compliance Participants who are unlikely to comply with the studys requirements or follow the rehabilitation program may be excluded Metallic Implants or Devices Individuals with metallic implants or devices that are not MRI-compatible may be excluded from the DTI scanning portion of the study Non- Traumatic Spinal cord injuries Vascular events like Spinal cord infarction or hemorrhage Tumors like Primary or metastatic tumors compressing the spinal cord Infections like Spinal abscess or inflammation due to infections like tuberculosis Autoimmune conditions like transverse myelitis or multiple sclerosis affecting the spinal cord.
结局指标
主要结局
DTI diffuse tensor imaging
时间窗: DTI diffuse tensor imaging-Day-0(Before Intervention) and End of 12th week(After the last day) | American spinal injury association impairment scale-Day-0(Before Intervention) and End of 12th week(After the last day) | The spinal cord independence measurement scale SCIM | -Day-0(Before Intervention) and End of 12th week(After the last day)
American spinal injury association impairment scale
时间窗: DTI diffuse tensor imaging-Day-0(Before Intervention) and End of 12th week(After the last day) | American spinal injury association impairment scale-Day-0(Before Intervention) and End of 12th week(After the last day) | The spinal cord independence measurement scale SCIM | -Day-0(Before Intervention) and End of 12th week(After the last day)
The spinal cord independence measurement scale SCIM
时间窗: DTI diffuse tensor imaging-Day-0(Before Intervention) and End of 12th week(After the last day) | American spinal injury association impairment scale-Day-0(Before Intervention) and End of 12th week(After the last day) | The spinal cord independence measurement scale SCIM | -Day-0(Before Intervention) and End of 12th week(After the last day)
次要结局
- Not applicable(Not applicable)
研究者
kishoremoy das
Saveetha College of Physiotherapy Saveetha Institute of Medical and Technical Sciences