Exploring the Effect of Non-invasive Brain Stimulation Paired With Functional Electrical Stimulation to Improve Lower Extremity Function Following Incomplete Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Time taken to complete the recruitment of 12 participants
研究概览
简要总结
This project is randomized controlled trial which will explore the effect of pairing repetitive Transcranial Magnetic Stimulation (rTMS) with Functional Electrical Stimulation (FES) Cycling on lower extremity function in people with incomplete spinal cord injury and compare the effects to each one of these interventions alone.
详细描述
Following a spinal cord injury, people often have decreased strength and balance in their legs, making it difficult to walk. To improve leg function in people with spinal cold injuries, the investigators can use electrical stimulation on muscles while participants are cycling to increase the muscle activation and nerve connections. Another way to improve the nerve connections to the muscles is by stimulating the brain directly. Previous research has looked at the effects of each of these treatments, but they have not been used together. In this study, the investigators will pair both electrical stimulation on the legs during cycling with brain stimulation or a sham brain stimulation to improve recovery and determine if using these methods together results in better outcomes, such as increased walking speed. Participants will attend training sessions for six weeks, twice per week. Each person will first receive the active or sham brain stimulation at the beginning of the session for 30 minutes and then they will receive the electrical stimulation on their legs while cycling for 60 minutes. Participants will be evaluated before the start of the treatment, in the middle of the study, at the final session, and again two weeks after the last session of the treatment. Assessments will include clinical tests of gait, balance, and strength. Inertial Measurement Units (IMU) and a pressure sensor gait mat will be used to evaluate the gait and balance parameters.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants are blinded to their groups. Research assistant and physiotherapist who are responsible for conducting assessment sessions are also blinded to participants group.
All the participants will be randomized to groups using opaque envelopes blocked by four and stratified by AIS score.
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
- •having motor incomplete SCI with level C or D on the American Spinal Injury Association Impairment Scale (AIS) with the lesion at any level of the cord resulting from either traumatic or non-traumatic etiology who are at least one-year post-injury.
- •having non-progressive SCI
- •being able to walk independently for 10 meters without help from another person
排除标准
- •other orthopedic or neurological implications that affect the lower extremity function
- •contraindications to FES (e.g., implanted electronic devices, unhealed bone fractures, sever contractures, extreme osteoporosis or osteoarthritis)
- •contraindications to rTMS (e.g., metal implants, history of seizure, cochlear implants)
结局指标
主要结局
Time taken to complete the recruitment of 12 participants
时间窗: 8 weeks
This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the feasibility of the protocol.
Proportion of participants recruited from the total number screened
时间窗: 8 weeks
This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the feasibility of the protocol.
Number of sessions attended by each participant
时间窗: 8 weeks
This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the tolerability of the protocol.
Number of dropouts in each group
时间窗: 8 weeks
This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the tolerability of the protocol.
Willingness of participants to undergo therapy
时间窗: 8 weeks
This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the tolerability of the protocol. The willingness of participation will be collected on an 11-point numerical rating scale with 'not at all willing' at 0, and 'very willing' at 10 (measured at baseline).
Incidence of treatment-emergent adverse events
时间窗: 8 weeks
This outcome will be evaluated through descriptive data. Safety will be presented as any adverse reaction reported on verbal questioning at each session. The number of participants reporting adverse reactions, and the duration and severity of the adverse reactions will be reported.
次要结局
- Timed Up and Go (TUG) test(8 weeks)
- Walking speed(8 weeks)
- Step length(8 weeks)
- Step width(8 weeks)
- Cadence(8 weeks)
- Sit-to-stand test(8 weeks)
- Postural sway test(8 weeks)
- Walking Index for Spinal Cord Injury (WISCI) II scale(8 weeks)
- Lower Extremity Motor Score (LEMS)(8 weeks)