NCT03451474终止不适用
Restoring Hand Function Utilizing Nerve Transfers in Persons With Cervical Spinal Cord Injuries
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Upper extremity muscle strength of left arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale
研究概览
简要总结
The primary objective of this study is to evaluate the safety and efficacy of nerve transfer surgery for restoring hand function as a therapy for patients with cervical spinal cord injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Spinal Injury Association (ASIA) grade of A, B, or C, or with a diagnosis of central cord syndrome, showing minimal to no evidence of functional improvement in motor examination after at least 6 months of non-operative therapy post-injury
- •>6 months post-injury
- •International Classification of Surgery of the Hand in Tetraplegia (ICSHT) category 0-4
- •Cervical spinal cord injury resulting in arm & hand functional impairment, with at least preserved elbow flexion
- •Physically and mentally willing and able to comply with study protocol
- •Lives in the immediate area and has no plans to relocate
- •Provides informed consent and HIPAA release of medical information
排除标准
- •Active infection
- •Any return or ongoing clinical recovery of distal motor function within 6 months after injury
- •Physically/mentally compromised
- •Systemic disease that would affect the patient's welfare or the research study
- •Immunologically suppressed or immunocompromised
- •Currently undergoing long-term steroid therapy
- •Active malignancy
- •Pending litigation or receiving Workers Compensation related to injury or accident
- •Pregnancy
- •Significant contractures and/or limitations in passive range of motion in the arm or hand
- •Poorly controlled upper extremity spasticity
- •Uncontrolled pain or hypersensitivity
- •Previous or current injury preventing use of tendon transfers to restore upper extremity function
- •History of brachial plexus injury or systemic neuropathic process
- •In the opinion of the Principal Investigator the subject would not be a candidate for the procedure
结局指标
主要结局
Upper extremity muscle strength of left arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale
时间窗: post-operative at 24 months
The GRASSP is a measure of upper extremity strength, sensation, and grip that is specific to patients with tetraplegia. It consists of 5 subscales for each upper extremity, and this measure will report the strength subscale (manual muscle testing of 10 muscles in right arm - subscale total score encompasses all 10 muscles). The strength subscale total score ranges from 0 to 50. The GRASSP will be administered by the nurses or physical therapist involved in the study.
Upper extremity muscle strength of right arm as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength subscale
时间窗: post-operative at 24 months
e GRASSP is a measure of upper extremity strength, sensation, and grip that is specific to patients with tetraplegia. It consists of 5 subscales for each upper extremity, and this measure will report the strength subscale (manual muscle testing of 10 muscles in right arm - subscale total score encompasses all 10 muscles). The strength subscale total score ranges from 0 to 50. The GRASSP will be administered by the nurses or physical therapist involved in the study.
次要结局
- Strength as assessed by Hand Held Dynamometry (HHD)(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
- Strength as assessed by Manual Muscle Testing (MMT)(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
- Total Score on the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) scale(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
- Function (mobility) as assessed by the Spinal Cord Independence Measure III Self Report (SCIM III SR) questionnaire(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
- Function as assessed total score on the Spinal Cord Independence Measure III Self Report (SCIM III SR) questionnaire(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
- Hand function as assessed by the Michigan Hand Questionnaire (MHQ) total score(Pre-operative, post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
- Motor neuron signaling as assessed by electromyography (EMG)(Pre-operative, post-operative at 6 months, 1 year, and 2 years)
- Function (self-care) as assessed by the Spinal Cord Independence Measure III Self Report (SCIM III SR) questionnaire(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
- Number of participants who receive the nerve transfer intervention soon after their spinal cord injury(at the time of the nerve transfer intervention)
- Number of participants with an improvement in hand function as determined by qualitative video analysis(Pre-operative, post-operative at 6, 12, and 24 months)
- Strength as assessed by the American Spinal Injury Association (ASIA) Upper Extremity Motor Score (UEMS)(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
- Dorsal sensation as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) dorsal sensation subscale(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
- Hand function as assessed by the Sollerman Hand Function Test total score(Pre-operative, post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
- Disability as assessed by the Disabilities of the Arm, Shoulder, and Hand (DASH) instrument total score(Pre-operative, post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
- Health-related Quality of Life as assessed by the Short Form 36 (SF-36) questionnaire total score(Pre-operative, post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
- Number of participants with intraoperative complications(24 months)
- Number of participants who require reoperation(24 months)
- Palmar sensation as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) palmar sensation subscale(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
- Qualitative grasp as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) qualitative grasp subscale(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
- Quantitative grasp as assessed by the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) quantitative grasp subscale(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
- Function (respiration and sphincter management) as assessed by the Spinal Cord Independence Measure III Self Report (SCIM III SR) questionnaire(Pre-operative (5 repeated measurements over 2 months), post-operative at 2 weeks, 3 months, 6 months, 12 months, and 24 months)
- Number of participants with post-operative complications(24 months)
研究者
研究点 (2)
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