The Effectiveness of Robotic Exoskeleton on Sensori-motor Performance in Subjects With Incomplete Spinal Cord Injury: A Functional Near-Infrared Spectroscopy Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Duration of a turn
研究概览
简要总结
This study investigates the impact of exoskeleton training on individuals with incomplete spinal cord injury (iSCI). Investigators focus on assessing how the use of the exoskeleton influences balance control and turning during ambulation and quality of life in this population. The study mainly involves interventions with participants utilizing exoskeleton devices to explore the influence on mobility, stability, and neuroplasticity, providing new insights into the potential benefits of exoskeleton training for individuals with incomplete spinal cord injuries.
详细描述
Spinal cord injury (SCI) poses profound challenges to individuals, disrupting complex neural pathways responsible for motor and sensory functions. Across a spectrum of impairments, the ability to navigate and maneuver during walking, particularly turning, is a significant obstacle for patients with incomplete SCI (iSCI). Despite advances in rehabilitation strategies, turning-while-walking remains a biomechanically demanding task that is often overlooked in traditional interventions that focus primarily on linear gait training.
Turning-while-walking requires coordinated movements of the head, trunk, pelvis, and limbs. Disruption of sensory pathways and impairment of motor control after iSCI complicates this complex process, resulting in impaired balance, increased risk of falls, and decreased quality of life. While traditional rehabilitation methods strive to address these challenges, they often fail to target the specific complexities of turning dynamics.
Robotic exoskeletons are wearable devices designed to enhance mobility for iSCI patients. These innovative technologies are expected to enhance sensorimotor performance by providing external support, promoting gait symmetry, and promoting neuroplasticity through intensive training. Exoskeleton-assisted therapy has the potential not only to restore physical function, but also to promote psychosocial well-being, allowing individuals to participate more fully in daily activities and social interactions.
However, despite the growing body of research demonstrating the benefits of exoskeleton training, its efficacy in improving turning-while-walking performance among individuals with iSCI remains uncertain. Furthermore, the neurological mechanisms underlying the response to exoskeleton training in this population warrant deeper investigation.
This study aims to elucidate the effectiveness of a robotic exoskeleton on sensorimotor performance in subjects with iSCI. By filling gaps in the existing literature through rigorous methodology and comprehensive evaluation, investigators strive to provide valuable insights into the potential of exoskeleton-assisted therapy to optimize rehabilitation outcomes and improve the lives of iSCI survivors. Through a multidimensional approach encompassing both physical and psychosocial domains, this research seeks to pave the way for more tailored and effective interventions in SCI rehabilitation, ultimately fostering greater independence and well-being for those affected by this debilitating condition.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-65 years
- •Traumatic or non-traumatic SCI, > 6 months since SCI onset Motor incomplete SCI (American Spinal Injury Association Impairment Scale, AIS C and D), neurologic level of injury (NLI) between C1-L2 (inclusive), as determined by the International Standards for Neurological Classification of SCI (ISNCSCI)
- •Able to walk with or without walking aid independently for at least 2 meters
- •No current or history of other neurological conditions
- •Community-dwelling or living in a rehabilitation facility
- •Medically stable for full weight-bearing locomotor training including 15-minute standing frame trial to assess standing tolerance
- •Weigh 220 pounds (100 kg) or less (exoskeleton equipment requirement)
- •Between approximately 1.5 m and 1.9 m (5'0" and 6'4") tall (exoskeleton equipment requirement)
- •Standing hip width of approximately 45 cm (18") or less (exoskeleton equipment requirement)
- •Sufficient range of motion (ROM) to achieve a normal, reciprocal gait pattern, and normal sit-to-stand transitions.
- •Hip extension greater than or equal to 5-degree Knee extension greater than or equal to 5-degree Ankle dorsiflexion greater than or equal to 0-degree
- •Sufficient upper extremity strength to use a front wheeled walker by manual muscle testing (minimum triceps strength bilaterally of 3/5 of Oxford Scale, shoulder abduction and flexion/extension 4/5 of Oxford Scale)
排除标准
- •AIS-A SCI or AIS-B SCI
- •Have been trained in exoskeleton or other robotic device for locomotor training within the past 4 months except for one or two training/demonstration sessions
- •Currently involved in another intervention study
- •Any medical issue that precludes full weight-bearing locomotor training including but not limited to:
- •Spinal instability (or spinal orthotic unless cleared by physician) Acute deep vein thrombosis (DVT) with activity restrictions Severe, recurrent autonomic dysreflexia (AD) requiring medical intervention Heterotopic ossification (HO) in the lower extremities resulting in ROM restrictions at the hips or knees Two or more pathological fractures in the last 48 months in a major weight-bearing bone (femur or tibia) in the lower extremity Hip subluxation (x-rays will be obtained for individuals injured prior to 10 years of age)
- •Any medical issue that would affect participant safety either due to cognitive deficits/impulsivity, intolerance to mild exercise, or other factors
- •Any issue that would confound results such as a concurrent neurological injury or disorder (other than SCI) or other factors
- •Skin integrity issues in areas that contact the device (including abdominal ostomies) or that would prohibit sitting
- •Participants who do not meet the exoskeleton equipment requirements
- •Modified Ashworth Scale (MAS) = 4 in the majority of lower extremity joints (e.g. greater than or equal to four joint movements in bilateral lower extremities when testing hip flexion/extension, knee flexion/extension, ankle dorsi/plantar flexion)
研究组 & 干预措施
Exoskeleton Training Group
EksoNR robotic training includes 10 min warm-up, and 5 min cool down (2x/wk, 12 weeks, 24 sessions), minimum 300 steps per session after the third session. The 45 min training excludes set-up/donning/doffing time and includes standing/up time, walking time, and seated rest breaks. The EksoNR training includes weight shift, stepping, straight walking with symmetry gait pattern, and turning with asymmetry gait pattern.
干预措施: Exoskeleton Training (Device)
Conventional Training Group
Participants in this group will receive 24-session conventional physical therapy (2x/wk, 12 weeks). Each session lasts 60 minutes, including 10 min warm-up, and 5 min cool-down. Conventional training includes mobilization exercises, strengthening exercises, and balance and gait training. The sessions will be supervised by a trained physiotherapist who will provide guidance and cues to the participants throughout. EksoNR training sessions will be provided after the completion of all the assessments.
干预措施: Conventional Physical Therapy (Other)
Usual Care Group
Participants in this group continue with daily activities as normal over 12 weeks. No new gait training, mobility therapy, or new medications related to the condition under study, will be commenced during the study period. Participants in this group come to the study sites for evaluations at baseline, 6 weeks, 12 weeks, and one-month follow-up. EksoNR training sessions will be provided after the completion of all the assessments.
结局指标
主要结局
Duration of a turn
时间窗: baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up
The participants are asked to walk a straight line of 1 meter, execute a 180-degree turn, and return to the starting position as quickly and safely as possible. Participants have the flexibility to use any necessary walking aids and wear their ankle-foot orthotics as needed. A turn is defined as starting and completing a 180-degree change in walking direction at a marked turn spot on the floor. The start of the turn is determined as the last foot contact prior to the inanition of the direction change. The end of the turn is determined as the last foot contact when both feet turn in the backward direction. Two tripod-mounted video cameras are placed in sagittal plane and frontal plane respectively. An assessor will view the videotapes of the turn by using a video-cassette player. The duration of a turn will be extracted and computed averages of three trials on each side.
Number of steps to a turn
时间窗: baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up
The participants are asked to walk a straight line of 1 meter, execute a 180-degree turn, and return to the starting position as quickly and safely as possible. Participants have the flexibility to use any necessary walking aids and wear their ankle-foot orthotics as needed. A turn is defined as starting and completing a 180-degree change in walking direction at a marked turn spot on the floor. The start of the turn is determined as the last foot contact prior to the inanition of the direction change. The end of the turn is determined as the last foot contact when both feet turn in the backward direction. Two tripod-mounted video cameras are placed in sagittal plane and frontal plane respectively. An assessor will view the videotapes of the turn by using a video-cassette player. The number of steps to a turn will be extracted and computed averages of three trials on each side.
次要结局
- The Timed Up and Go Test (TUGT)(baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up)
- Limits of Stability (LOS)(baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up)
- Modified Clinical Test of Sensory Integration and Balance (m-CTSIB)(baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up)
- Muscle strength(baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up)
- Modified Ashworth Scale (MAS)(baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up)
- Modified Functional Reaching Test (MFRT)(baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up)
- Berg Balance Scale (BBS)(baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up)
- 10 Meter Walk Test (10MWT)(baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up)
- Walking index for spinal cord injury (WISCI II)(baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up)
- Fall incidence(baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up)
- The 36-Item Short Form Health Survey (SF-36)(baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up)
- Falls Efficacy Scale International (FES-I)(baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up)
- Physical Activity Scale for Persons with Physical Disabilities (PASIPD)(baseline, session 12 (6 Weeks), session 24 (12 Weeks), 1-month follow-up)