Progressive Resistance Training in Acute Spinal Cord Injury: a Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change in muscular strength - handheld dynamometry
研究概览
简要总结
Muscle weakness is one of the most common and debilitating symptoms following a Spinal Cord Injury (SCI). Strength training is recommended as an effective means to increase muscular strength and improve function for individuals with long term SCI. In contrast, the strength training guidance for those with a recent (<1 year) SCI is lacking. Therefore, this study aims to investigate the feasibility of a method of upper limb strengthening - Progressive Resistance Training (PRT) and its impact upon muscle strength and function.
详细描述
The trial and recruitment will be conducted at the Queen Elizabeth National Spinal Injuries Unit (QENSIU), Glasgow. Individuals with tetraplegia and upper limb weakness will be randomly allocated to receive either a tailored progressive resistance training (PRT) programme alongside usual care or usual care alone.
Up to 30 participants admitted to the QENSIU will be recruited to the study. They will be randomised to the intervention or control group. The intervention group will receive 8 weeks of PRT. An upper limb functional goal will be identified through discussion with the researcher and the participant. PRT will be individually tailored to target two muscle groups which contribute to achieving this goal. For each muscle group 3 sets of 8-10 repetitions will be carried out, resistance will be applied using wrist weights, free weights or resistance bands as required. Measurements of muscle strength and function will be assessed prior to, and following the study. Outcome measures: Manual muscle testing, Handheld Dynamometry, The Spinal Cord Independence Measure, The Action Research Arm Test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acquired non-progressive SCI - traumatic, spinal cord stroke, surgical injury
- •Within 2 weeks of being identified as medically stable by the treating consultant
- •Over 18 years old
- •Individuals classified with complete or incomplete tetraplegia (C1-C8), graded A-D according to the American Spinal Injury Association (ASIA) scale
- •Bilateral or unilateral partial paresis of at least two muscle groups of the upper limb
- •Manual muscle testing grade 2-4 strength in target muscle groups
- •Able to tolerate sitting upright in a wheelchair for at least 2 hours
排除标准
- •Acute condition impairing a participant's ability to perform PRT (e.g. fracture)
- •Proven or suspected neuromuscular weakness affecting the upper limbs due to another condition (e.g. stroke or Guillain-Barré syndrome)
- •Unable to follow instructions in English
- •Symptomatic cardiac disease
- •Ventilator dependency
- •Severe spasticity
- •Uncontrolled autonomic dysreflexia
- •Likely to be discharged before the end of the intervention
结局指标
主要结局
Change in muscular strength - handheld dynamometry
时间窗: Baseline, 8 weeks
Muscular strength will be quantified using handheld dynamometry, the main upper limb muscle groups will be assessed, bilaterally. Shoulder flexors, extensors, abductors, adductors, lateral rotators, and medial rotators, elbow flexors and extensors, forearm pronators and supinators, and wrist flexors and extensors will be assessed. The order of testing the muscle groups will be consistent. Handheld dynamometry will be conducted implementing the 'make' test. The participant will exert a maximal force against the device whilst the assessor will maintain the position of the device. Three trials will be performed for each upper limb muscle group. Prevention of muscle fatigue will be achieved by a 30-second recovery after each trial and 2 minutes rest between muscle groups. One or 2 trials will be used to familiarise participants with the testing procedure.
次要结局
- Perception of ability(8 weeks)
- Manual muscle testing(Baseline, 8 weeks)
- The Spinal Cord Independence Measure (SCIM III)(Baseline, 8 weeks)
- The Action Research Arm Test (ARAT)(Baseline, 8 weeks)