Nerve Transfers to Restore Hand Function in Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Upper extremity function - Range of motion
研究概览
简要总结
This study seeks to evaluate the efficacy of nerve transfers in restoring hand function in patients with cervical spinal injuries.
详细描述
Cervical spinal cord injury is a life-altering injury that results in profound loss of upper limb function. Hand function is essential to basic activities of daily living and consequently has a significant impact on patients' quality of life. Tendon transfers and/or tenodesis have traditionally been used to restore hand function in spinal cord injuries - however, in recent years there is growing interest in the role of nerve transfers as a means of accomplishing this goal. Although preliminary results indicate nerve transfers may be well-suited for patients with spinal cord injury, their long term efficacy has not been demonstrated.
This study seeks to evaluate the efficacy of nerve transfers in restoring hand function in patients with cervical spinal injuries. Eligible patients will receive nerve transfer procedure(s) (e.g. brachialis to anterior interosseous nerve, supinator to posterior interosseous) and will be followed post-operatively to assess for changes in strength, functional independence, and quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a spinal cord injury AIS level C5 to C
- •Those with motor complete injuries (AIS A or B) will be considered for surgical intervention if they are ≥ 5 months post injury. Motor incomplete patients (AIS C or D) will be considered if they are ≥ 1.5 years post injury.
- •Patients will require ≥ MRC 4 strength of the muscle supplied by the donor nerve (e.g. brachialis, supinator).
- •Finger flexor and extensor strength should be ≤ MRC 1 strength.
- •Muscles supplied by the donor nerve, will need to have no or minimal of evidence of lower motor neuron injury as dictated by evidence of fibrillations, positive sharp waves, or moderate or severely decreased recruitment on needle electromyography.
- •Those being evaluated for surgery outside nine-months post injury recipient muscles will be required to be free of lower motor neuron pathology.
- •Ability to comply and participate in rigorous post-surgical therapy regimen.
排除标准
- •Comorbidities precluding safe surgery including autonomic/hemodynamic instability, pulmonary instability, active infection, chronic pressure sores or untreated urinary tract infections as determined by physician.
- •Simultaneous tendon transfer or tenodesis surgery (which would preclude separation of the effect of nerve transfer alone).
结局指标
主要结局
Upper extremity function - Range of motion
时间窗: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Quantitative assessment of range of motion (degrees)
Upper extremity function - Manual muscle testing (MRC)
时间窗: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Quantitative assessment of motor function (MRC)
Upper extremity function - Graded Redefined Assessment of Strength, Sensibility and Prehension test (GRASSP)
时间窗: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Valid, reliable and responsive measure of sensorimotor upper limb impairment specifically designed for patients with cervical SCI
Upper extremity function - Myometric measures of strength (donor and recipient muscle groups)
时间窗: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Valid and reliable quantitative muscle strength measurement
次要结局
- Health related quality of life - Canadian Occupational Performance Measure (COPM)(Change from baseline at 6, 12, 24, 30 and 36 months post-surgery)
- Health related quality of life - Semi-structured interviews(Collected at 12 and 24 months post-surgery.)
- Health related quality of life - Spinal Cord Independence Measure (SCIM I)(Change from baseline at 6, 12, 24, 30 and 36 months post-surgery)
- Health related quality of life - The Short Form (SF)-36(Change from baseline at 6, 12, 24, 30 and 36 months post-surgery)