Transcutaneous Spinal Cord Stimulation With Robotic Gait Training in Chronic SCI

Официальное название

A Pilot Study on the Cumulative Effects of Transcutaneous Spinal Cord Stimulation (tSCS) With Robotic Gait Training in Trunk Muscle Activity and Walking Index in Chronic Spinal Cord Injury

Обзор

This study is aimed to evaluate whether transcutaneous spinal cord stimulation (tSCS) can augment robotic gait training (RGT) to improve functional mobility in participants with chronic spinal cord injuries. It also evaluate the impact of the tSCS+RGT on health-related quality of life (HRQOL), compared to RGT alone. This is a prospective single-arm crossover study in participants with incomplete chronic traumatic spinal cord injury. 6 subjects with paraplegia and 6 subjects with tetraplegia will be recruited. The intervention includes Phase 1 of training which consists of 16 sessions of robotic gait training (RGT) + conventional physiotherapy in 8-10 weeks, and Phase 2 of training which consists of 16 sessions of RGT training + tSCS + conventional physiotherapy in 8-10 weeks. Outcome measures including mobility function assessment and neuromuscular assessment will be collected at Baseline, Post-Phase 1 and Post-Phase 2. A satisfaction survey on the intervention "RGT training + tSCS + conventional physiotherapy" will be performed at week-18 assessment.

Подробное описание

This study is aimed to evaluate whether transcutaneous spinal cord stimulation (tSCS) can augment robotic gait training (RGT) to improve functional mobility in participants with chronic paraplegia. It also evaluate the impact of the tSCS+RGT on health-related quality of life (HRQOL), compared to RGT alone.

This is a prospective single-arm crossover study in participants with incomplete chronic traumatic spinal cord injury. 6 subjects with paraplegia and 6 subjects with tetraplegia will be recruited. Once subject is identified to be eligible for the study and is agreeable to participate into the study, he/she will undergo Phase 1 of training which consists of 16 sessions of robotic gait training (RGT) + conventional physiotherapy in 8-10 weeks. After a 1-week washout period, subject will undergo Phase 2 of training which consists of 16 sessions of RGT training + tSCS + conventional physiotherapy in 8-10 weeks.

Subject will walk with EksoGT for gait training during RGT training. Components of conventional physiotherapy will include lower limb ergometry and strength training as prescribed by the attending physiotherapist based on their assessment. During tSCS, two surface electrodes will be positioned in between the vertebral processes located generally one vertebral segment rostral and one vertebral segment caudal to the site of injury. Reference/Ground electrodes placed over the ASIS. It will be on biphasic mode with an overlap frequency of 10kHz, Burst Frequency of 30Hz, Pulse width of 1ms. Stimulation intensity ranges from 5-100 mA and will be adjusted according to the patient's response. The tSCS stimulation duration for each session will be 45 minutes in conjunction with the RGT training

Outcome measures including mobility function assessment and neuromuscular assessment will be collected at Baseline (within 1 week before the starting of Phase 1 of training), Post-Phase 1 (within 1 week after Phase 1 of training) and Post-Phase 2 (within 1 week after Phase 2 of training).

A satisfaction survey on the intervention "RGT training + tSCS + conventional physiotherapy" will be performed at week-18 assessment.

Вмешательства

• Устройство RGT+ tSCS + conventional physiotherap
  Subject will undergo 16 sessions of robotic gait training (RGT) + tSCS+ conventional physiotherapy in 8-10 weeks. Subject will walk with EksoGT for gait training during RGT training. Components of conventional physiotherapy will include upper/lower limb ergometry and strength training as prescribed by the attending physiotherapist based on their assessment. During tSCS, cathodes will be placed on the T11 and L1 spinous process. Reference/Ground electrodes placed over the ASIS It will be on bipha
• Устройство RGT+ conventional physiotherapy
  Subject will undergo 16 sessions of robotic gait training (RGT) + conventional physiotherapy in 8-10 weeks. Subject will walk with EksoGT for gait training during RGT training. Components of conventional physiotherapy will include upper/lower limb ergometry and strength training as prescribed by the attending physiotherapist based on their assessment.

Первичные конечные точки

• Spinal Cord Injury - Trunk Control Test (SCI-TCT) [Срок оценки: Week 0]
• Spinal Cord Injury - Trunk Control Test (SCI-TCT) [Срок оценки: Week 8]
• Spinal Cord Injury - Trunk Control Test (SCI-TCT) [Срок оценки: Week 17]
• Walking Index in Spinal Cord Injury-II (WISCI-II) [Срок оценки: Week 0]
• Walking Index in Spinal Cord Injury-II (WISCI-II) [Срок оценки: Week 8]
• Walking Index in Spinal Cord Injury-II (WISCI-II) [Срок оценки: Week 17]
• 10-Meter Walk Test (10MWT) [Срок оценки: Week 0]
• 10-Meter Walk Test (10MWT) [Срок оценки: Week 8]
• 10-Meter Walk Test (10MWT) [Срок оценки: Week 17]
• Central motor conduction time (CMCT) [Срок оценки: Week 0]

Вторичные конечные точки (9)

• EQ5D [Срок оценки: Week 0]
• EQ5D [Срок оценки: Week 8]
• EQ5D [Срок оценки: Week 17]
• Modified Tardieu Scale [Срок оценки: Week 0]
• Modified Tardieu Scale [Срок оценки: Week 8]
• Modified Tardieu Scale [Срок оценки: Week 17]
• EMG measurement [Срок оценки: Week 0]
• EMG measurement [Срок оценки: Week 8]
• EMG measurement [Срок оценки: Week 17]

Критерии участия

Критерии включения

• Between 6 months to 5 years from the diagnosis of the traumatic SCI and who are not walking independently;
• Age between 21 to 65 years old;
• Incomplete spinal cord injury: ASIA Impairment Scale (AIS) Grade: B-D;
• Spinal cord injury level: T1- L1, or C2-C8;
• SCI-TCT Score > 13;
• Capable of providing an informed consent;
• Cleared by Neurosurgeons/ Orthopeadic Surgeons for tSCS;
• Meets prerequisites for Ekso wearable robotic exoskeleton training.

Критерии исключения

• Participant has uncontrolled cardiopulmonary disease or cardiac symptoms as determined by the investigator;
• Participant has any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound performance and outcomes like uncontrolled neuropathic pain, depression, severe cognitive impairment;
• Unstable or uncontrolled autonomic dysreflexia;
• Requires ventilator support;
• Spasms that limit the ability of the subjects to participate in the study training as determined by the investigator;
• Skin conditions that limit the application of tSCS electrodes;
• Active implanted medical devices that may be affected by tSCS;
• Pregnant, planning to become pregnant or breastfeeding;
• Concurrent participation in another drug or device trial that may interfere with this study;
• Participated in wearable exoskeleton training within the last 3 months prior to enrolment.
• Peripheral nerve injury or significant Lumbar Radiculopathy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Сингапур · 1 центр

• Alexandra Hospital — Singapore

Идентификаторы

NCT: NCT05921175 · 2023/00350 & 2024/4401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗