CTRI/2023/06/053486招募中1/2 期
EZ-LOCK Orthosis
TTK CenteR for Rehabilitation Research and Device Development, IIT Madras1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年6月15日最近更新:
试验速览
- 阶段
- 1/2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Ease of Use and Reliability of locking
研究概览
简要总结
The study is being conducted to compare the functioning and efficacy of a newly designed orthotic knee joint called EZ-LOCK against conventional drop lock type orthotic knee joint for KAFO (knee ankle foot orthoses) users.
It is hypothesised that the EZ-LOCK joint will simplify and ease stand-to-sit and sit-to-stand transitions while being safe and effective compared to a conventional drop-lock KAFO, for both unilateral and bilateral KAFO users.
15 users have been recruited until now
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Quadriceps muscle weakness with (MRC<3) 2) People who independently walk with unilateral/bilateral KAFO for at least 100 m 3) People who transfer independently with unilateral/bilateral KAFO 4) Upper limb strength sufficient to operate the new knee joint 5) Over 1 m tall.
排除标准
- •Impaired cognition 2) Impaired perception 3) Fair to poor standing balance when using unilateral/bilateral KAFO 4) Acute pain in hip, knee and ankle joint 5) Knee flexion contracture greater than 10° 6) Pregnant women 7) Children 8) Abnormal BP 9) Orthostatic hypotension 10) Cardio vascular condition 11) Severe osteoarthritis 12) Standing endurance less than 15 minutes 13) Sensory impairment 14) Poor coordination 15) Poor dexterity.
结局指标
主要结局
Ease of Use and Reliability of locking
时间窗: Pre-Intervention - Evaluation to be done on day 0 | Post-Intervention - To be done 21 days after evaluation | Follow up - To be done 30 days after evaluation
次要结局
- Gait Stability(Pre-Intervention - Evaluation to be done on day 0)
- Actuation Speed(Pre-Intervention - Evaluation to be done on day 0)
研究者
研究点 (1)
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