Transcutaneous Spinal Cord Stimulation (tSCS) During Assisted Cycling Training for Incomplete Spinal Cord Injury: a Randomized, Double-blind Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Lower Extremity Motor Score (LEMS) according to the International Standards for Neurological Classification of Spinal Cord Injury.
研究概览
简要总结
The goal of this clinical trial is to learn if transcutaneous spinal cord stimulation works to improve lower limb motor function in adults with incomplete spinal cord injury. It will also learn about the safety of transcutaneous spinal cord stimulation when combined with assisted cycling training.
The main questions it aims to answer are:
Does transcutaneous spinal cord stimulation while training with assisted cycling improve lower limb motor function? Does transcutaneous spinal cord stimulation while training with assisted cycling reduce muscle spasms or improve bladder or bowel function?
Researchers will compare transcutaneous spinal cord stimulation to a sham (a look-alike stimulation that does not deliver therapeutic electrical current) to see if transcutaneous spinal cord stimulation during assisted cycling improves motor function in people with incomplete spinal cord injury.
Participants will:
Participate in the training program with assisted cycling. Receive active stimulation or placebo stimulation during this training. Undergo motor function assessments, and be monitored about muscle spasms, bladder and bowel function and side effects.
The study will include 40 participants with incomplete spinal cord injury with less than 12 months since injury.
详细描述
Project Title: Transcutaneous Electrical Spinal Cord Stimulation During Assisted Cycling Training for Incomplete Spinal Cord Injury. A Randomized Double-Blind Study.
Sponsor: Hospital Sant Joan de Déu Palma-Inca
Principal Investigator: Luis Garcés Pérez, MD. Attending Physician. Department of Rehabilitation. Hospital Sant Joan de Déu Palma-Inca
Study Site(s): Hospital Sant Joan de Déu Palma-Inca
Study Design: Randomized, double-blind, sham-controlled clinical trial
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
- Double (Participant, 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
- •Age at least
- •Diagnosis of spinal cord injury at levels C2-T11, classified as ASIA Impairment Scale grades B, C, or D.
- •Less than 1 year since the injury.
- •Ability to follow instructions and tolerate the intervention.
- •.-Spasticity grade less than 3 on the Modified Ashworth Scale.
- •Signed informed consent.
排除标准
- •Comorbidities that limit active participation (severe heart disease, serious active infections, pressure ulcers in the area).
- •Use of devices incompatible with electrical stimulation.
- •Metallic implant in the T11-T12 area.
- •History of epilepsy.
- •Fixed joint contractures limiting range of motion.
- •Significantly reduced bone density (osteoporosis).
- •Unhealed fractures.
- •Pregnancy.
- •Active tumor process.
研究组 & 干预措施
Active tSCS
Active tSCS with biphasic rectangular current at 50 Hz with a 1 ms pulse width (0.5 ms per phase).
20 sessions training with assisted cycling, each lasting 45 minutes. Electrodes placed on the dorsal region between T11 and T12 and abdominal muscles,
干预措施: Transcutaneous spinal cord stimulation on the dorsal region between T11 and T12 (Device)
Sham tSCS
Sham tSCS, using decreasing intensity. Using biphasic rectangular current at 50 Hz with a 1 ms pulse width (0.5 ms per phase). Once the sensory threshold is reached, it will be maintained for 30 seconds and then gradually decreased.
20 sessions training with assisted cycling, each lasting 45 minutes. Electrodes placed on the dorsal region between T11 and T12 and abdominal muscles,
干预措施: Sham transcutaneous spinal cord stimulation on the dorsal region between T11 and T12 (Device)
结局指标
主要结局
Lower Extremity Motor Score (LEMS) according to the International Standards for Neurological Classification of Spinal Cord Injury.
时间窗: From the initial assessment to the end intervention after 4 weeks
From 0 (no muscular function) to 25 (normal muscular funcion).
Muscle strength (MRC scale) in knee extensors and plantar flexors
时间窗: From the initial assessment to the end intervention after 4 weeks
From 0 (no muscle function) to 5 (normal muscle function) for each muscle groups
Isometric dynamometric force of knee extensors and ankle dorsiflexors in both lower limbs
时间窗: From the initial assessment to the end intervention after 4 weeks
In a seated position with 90° knee flexion and ankle in neutral. The mean of three repetitions will be recorded.
10-Meter Walk Test (10MWT)
时间窗: From the initial assessment to the end intervention after 4 weeks
This will also be recorded as dichotomous variable (able/unable).
Timed Up and Go (TUG)
时间窗: From the initial assessment to the end intervention after 4 weeks
This will also be recorded as dichotomous variable (able/unable).
Walking Index for Spinal Cord Injury II (WISCI II)
时间窗: From the initial assessment to the end intervention after 4 weeks
From 0 (no walking function) to 20 (normal walking function without helping aids)
次要结局
- Qualiveen questionnaire (Spanish version)(From the initial assessment to the end intervention after 4 weeks)
- Penn Spasm Frequency Scale.(From the initial assessment to the end intervention after 4 weeks)
- Modified Ashworth Spasticity Scale in knee extensors and plantar flexors.(From the initial assessment to the end intervention after 4 weeks.)
- Neurogenic Bowel Dysfunction (NBD) score (Spanish version)(From the initial assessment to the end intervention after 4 weeks)
研究者
Luis Garces Perez
Principal Investigator, Medical doctor in Physical and Rehabilitation Medicine
Fundació Sant Joan de Déu