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临床试验/CTRI/2024/03/064276
CTRI/2024/03/064276尚未招募3 期

Comparative Efficacy Of Neuro-Developmental Treatment (Bo-Bath – NDT) Versus Customized Functional Mobility Exercises With Orthosis In The Management Of Incomplete Spinal Cord Injury

Divya Khati1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月18日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
1. ASIA ISNCSCI

研究概览

简要总结

This is a two-way experimental study, comparative in nature. In this study, we are comparing two different interventions neurodevelopment treatment (NDT) and customized functional mobility exercises in the management of spinal cord injury. the main objective of this study is to know which treatment is more effective and beneficial for patients with incomplete spinal cord injury to improve the functional mobility of the patient. convenient sampling will be followed for the sampling of the patients. 30 patients will be enrolled for this study as per their willingness and will be divided into two groups. Group 1- consists of 15 subjects who will be treated with neurodevelopmental treatment (Bobath), and Group 2- consists of 15 subjects who will be treated with customized functional mobility exercises with an orthosis. duration of intervention will be 6 weeks (6 days/week and 1 day home exercise. treatment time will be 45 minutes/day. primarily focusing on muscle strength, coordination, balance, and gait, OR overall functional independence and quality of life of the patients.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Incomplete spinal cord injury (level of injury – below T10, ASIA-C)
  • Age groups between 20-40 years
  • Both genders (male and female)
  • The patients clinically diagnosed as incomplete spinal cord injury will be included for this study
  • Poor trunk control
  • lower extremity weakness Incoordination Poor balance.

排除标准

  • Comatose patients
  • Complete spinal cord injury
  • Medical instability
  • Any recent fracture or surgery
  • Recent myocardial infarction
  • Auditory impairment • Perceptual defects • Reflex sympathetic dystrophy • Mental retardation.

结局指标

主要结局

1. ASIA ISNCSCI

时间窗: 1. 3 times | 2. 3times | 3. 4 times | 4. 3times | 5. 2 times | 6. 2 times

2. Modified functional reach test

时间窗: 1. 3 times | 2. 3times | 3. 4 times | 4. 3times | 5. 2 times | 6. 2 times

3. Spinal cord injury independence measure (SCIM)

时间窗: 1. 3 times | 2. 3times | 3. 4 times | 4. 3times | 5. 2 times | 6. 2 times

4. Wheelchair skill test

时间窗: 1. 3 times | 2. 3times | 3. 4 times | 4. 3times | 5. 2 times | 6. 2 times

5. Spinal cord injury functional ambulation inventory (SCI-FAI)

时间窗: 1. 3 times | 2. 3times | 3. 4 times | 4. 3times | 5. 2 times | 6. 2 times

6. SF36 (short-form health survey)

时间窗: 1. 3 times | 2. 3times | 3. 4 times | 4. 3times | 5. 2 times | 6. 2 times

次要结局

未报告次要终点

研究者

发起方
Divya Khati
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Divya Khati

Lovely Professional University

研究点 (1)

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