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临床试验/CTRI/2023/02/049536
CTRI/2023/02/049536尚未招募2 期

FORMULATION, VALIDATION AND EFFECTIVENESS OF CORTICOSPINAL ACTIVATION PROTOCOL ON CENTRAL PATTERN GENERATOR IN INDIVIDUALS WITH SPINAL CORD INJURY

Punjabi University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年12月31日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Somato-Sensory Evoked Potentials, SEPs

研究概览

简要总结

Background: Spinal Cord Injury refers to a destructive,neurological and pathological state in which there occurs damage to the neural elements of the spinal cord. This damage can be due to traumatic and non-traumatic lesions which lead to dysfunctions in the functioning and participation of human being in the society (Bedi et al., 2018).Locomotion is a basic motor act which is essential for the survival of humans (Ray *et al.,*2022). The basic muscle synergies which are responsible for body propulsion are generated by the neurons in spinal cord collectively known as Central Pattern Generator for Locomotion.  SCIs are heterogeneous in casualty, severity and location of injury but Locomotion is the ultimate goal for the post-SCI survivors (Hang et al., 2010). In order for locomotion to occur, a complex CPG center of Locomotion activation is required. Exercise based approach i.e. Corticospinal Activation Protocol (CAP) is the cornerstone in the treatment and management of individuals with SCI.Study Design: A Randomised Controlled Trial

**Objective:**To determine the effectiveness of CAP on the activation of CPG in individuals with spinal cord injury

**Methodology:**The individuals with SCI/D will be screened and recruited for the study as per the selection criteria. Written consent will be obtained before the commencement of the study from the participants (Annexure III).

Step-I: A baseline evaluation on Day 0 will be done by using primary and secondary outcome measures of the study i.e MEPs, SEPs, WISCI, SCIM-III. Step II: The participants will be allocated into two groups. Group A (Experimental Group)  and Group B (Control Group)) based on the randomization.Step III: The protocol will be administered on the next day i.e at Day 1. After the selection of participants, the administration of protocol will be done which depends upon the allocated group.Experimental Group: Group A

For group-A CAP  which includes Corticospinal Activation Protocol to activate  CPG in the Spinal cord will be administrated to the participants 5 days weekly for 45 minutes along with conventional physiotherapy. Each participant will be randomly assigned. Control Group: Group BFor group B (control group),45 minutes of conventional exercise sessions will be given including strengthening exercises of the upper limb, trunk, and lower limb, body weight support treadmill training, functional electrical stimulation, balance and proprioception trainingStep IV: The Post-intervention recordings for the outcome measures of the study i.e. AIS Scores MEPs, SEPs, WISCI-II, SCIM-III will be recorded on Day 15 and Day 30.Step V:  Data will be collected and statistical analysis will be done using SPSS 16.0

Conclusion: An articulate approach and combinative approach utilizing neuroprotective and neuroregenerative strategies to simultaneously targeting multiple pathways will be beneficial for SCI patients. There is great demand for simple, multifaceted treatment method to maximize the effectiveness of neurorehabilitative strategy for SCI.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Individuals willing to enroll in the study 2.Individuals falling within the age group of 20-65 years 3.Both males and females will be included in the study.
  • 4.Individuals with traumatic or non-traumatic incomplete SCI with ASIA grade C and D.
  • 5.Individuals with intact cognitive function i.e. MMSE greater than or equals to 26.

排除标准

  • Individuals with a history of cognitive deficit, psychosomatic illness.
  • Individuals with a history of epilepsy, head injury, or loss of consciousness.
  • Individuals with visual disability.
  • Individuals with congenital spinal deformities and diseases like neural tube defects.
  • Individuals with Pregnancy, Metastasis 7.

结局指标

主要结局

Somato-Sensory Evoked Potentials, SEPs

时间窗: 5 sessions per week for 4 weeks

Motor Evoked Potentials, MEPs

时间窗: 5 sessions per week for 4 weeks

次要结局

  • Asia Impairment Scale (AIS) Scores(Walking Index for Spinal Cord Injury (WISCI))

研究者

申办方类型
Research institution

研究点 (1)

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