Trial Summary
What is the purpose of this trial?The overall aim of this project is to assess the effect of combining transcutaneous lumbosacral stimulation (TLS) during Exoskeleton Assisted Walking (EAW) compared to EAW alone without stimulation on walking recovery.
What safety data is available for exoskeleton and spinal cord stimulation treatments for spinal cord injury?The available safety data for exoskeleton and spinal cord stimulation treatments for spinal cord injury indicate that these devices are generally safe for use. Studies on devices like the Indego and ReWalk exoskeletons show limited adverse events, such as minor skin lesions and irritations, with no major incidents like falls reported. Participants in these studies were able to achieve basic mobility tasks and showed improvements in walking speed and endurance. Systematic reviews and meta-analyses suggest that while exoskeletons are safe, their effectiveness compared to other rehabilitation methods varies, and further research is needed to establish consistent benefits.13456
Is Exoskeleton-Assisted Walking a promising treatment for spinal cord injury?Yes, Exoskeleton-Assisted Walking is a promising treatment for spinal cord injury. It helps people with paralysis improve their walking ability and independence. Studies show that combining it with spinal cord stimulation can enhance walking performance and sensation. It is also considered safe and effective for improving mobility in both indoor and outdoor settings.25689
What data supports the idea that Exoskeleton + Spinal Cord Stimulation for Spinal Cord Injury is an effective treatment?The available research shows that using exoskeletons combined with spinal cord stimulation can help people with spinal cord injuries improve their walking abilities. In one study, participants who used the Indego exoskeleton showed improvements in walking speed and independence after 8 weeks of training. Another study found that combining exoskeleton walk training with spinal cord electrical stimulation helped increase foot loading forces and improved walking in some participants. This combination also enhanced sensations and motor function in some individuals. However, a systematic review found mixed results when comparing exoskeleton training to other rehabilitation methods, suggesting that more research is needed to fully understand its benefits.25678
Do I need to stop my current medications to join the trial?The trial protocol does not specify whether you need to stop taking your current medications.
Eligibility Criteria
This trial is for adults aged 21-58 who are wheelchair reliant due to a spinal cord injury (SCI) that occurred over 6 years ago. Participants must be between 62 and 74 inches tall, have some lower limb movement, and no history of bone fractures or diseases.Inclusion Criteria
My spinal cord injury is between my neck and mid-back.
I use a wheelchair all the time.
I am between 21 and 58 years old.
I have been unable to walk for over 6 years due to a spinal cord injury.
My leg strength score is 16 or higher.
Exclusion Criteria
I have had bone disease or injury in the past.
I have had broken bones in the past.
Treatment Details
The study is testing if using transcutaneous lumbosacral stimulation (TLS) while walking with an exoskeleton helps improve walking ability in people with SCI compared to just using the exoskeleton alone.
2Treatment groups
Experimental Treatment
Group I: EAW without TLSExperimental Treatment1 Intervention
EAW, exoskeleton-assisted walking, an activity based therapy is a training which involves using the same exoskeleton device for all the participants. Each participant will undergo, 60 minutes of EAW as above. Each participant will undergo a stand evaluation and be instructed in proper use of the device. During the initial 3 sessions of training, the exoskeleton device will be tethered to an overhead pulley system during training to allow subjects to safely adapt to trunk, balance gait activities while walking in the exoskeleton. EAW overground walking will follow each training session with the 6-minute walk test, 10 meter walk test .
Group II: EAW + TLSExperimental Treatment2 Interventions
The EAW+TLS training group will receive 60 minutes of exoskeleton-assisted walking overground per session, for a total of 80 sessions (3x/week, 28 wks.) with simultaneous transcutaneous lumbosacral stimulation (TLS) intervention followed by 15 minutes of over ground training without the exoskeleton. component is added to the exoskeleton assisted walking component in this group. TLS will involve placing self-adhesive stimulating electrodes bilaterally over the T11/T12 lumbar region. Correct placement will be confirmed by the elicitation of posterior root muscle reflexes in the lower limb muscles. A constant-voltage stimulator (RT 50 Sage stimulator) will deliver pulses of 2 ms width. TLS will be applied while the participant walks in the Exo-skeleton-assisted walking (EAW).
Exoskeleton-Assisted Walking is already approved in United States, United States, United States, United States for the following indications:
🇺🇸 Approved in United States as ReWalk for:
- Spinal cord injury (SCI) levels T7 to L5
- Stroke rehabilitation
🇺🇸 Approved in United States as Ekso GT for:
- Spinal cord injuries at levels T4 to L5
- Hemiplegia due to stroke
- Spinal cord injuries at levels C7 to T3
🇺🇸 Approved in United States as Indego for:
- Spinal cord injury (SCI) levels T7 to L5
- Rehabilitation institutions
🇺🇸 Approved in United States as ReWalk ReStore for:
- Rehabilitation of individuals with lower-limb disabilities due to stroke
Find a clinic near you
Research locations nearbySelect from list below to view details:
Kessler FoundationWest Orange, NJ
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Who is running the clinical trial?
Kessler FoundationLead Sponsor
Kessler Institute for RehabilitationIndustry Sponsor
References
Safety and tolerance of the ReWalk™ exoskeleton suit for ambulation by people with complete spinal cord injury: a pilot study. [2022]The objective of the study was to evaluate the safety and tolerance of use of the ReWalk™ exoskeleton ambulation system in people with spinal cord injury. Measures of functional ambulation were also assessed and correlated to neurological spinal cord level, age, and duration since injury.
Voluntary driven exoskeleton as a new tool for rehabilitation in chronic spinal cord injury: a pilot study. [2022]Treadmill training after traumatic spinal cord injury (SCI) has become an established therapy to improve walking capabilities. The hybrid assistive limb (HAL) exoskeleton has been developed to support motor function and is tailored to the patients' voluntary drive.
Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis. [2022]Powered exoskeletons are designed to safely facilitate ambulation in patients with spinal cord injury (SCI). We conducted the first meta-analysis of the available published research on the clinical effectiveness and safety of powered exoskeletons in SCI patients.
Device-Training for Individuals with Thoracic and Lumbar Spinal Cord Injury Using a Powered Exoskeleton for Technically Assisted Mobility: Achievements and User Satisfaction. [2018]Objective. Results of a device-training for nonambulatory individuals with thoracic and lumbar spinal cord injury (SCI) using a powered exoskeleton for technically assisted mobility with regard to the achieved level of control of the system after training, user satisfaction, and effects on quality of life (QoL). Methods. Observational single centre study with a 4-week to 5-week intensive inpatient device-training using a powered exoskeleton (ReWalk™). Results. All 7 individuals with SCI who commenced the device-training completed the course of training and achieved basic competences to use the system, that is, the ability to stand up, sit down, keep balance while standing, and walk indoors, at least with a close contact guard. User satisfaction with the system and device-training was documented for several aspects. The quality of life evaluation (SF-12v2™) indicated that the use of the powered exoskeleton can have positive effects on the perception of individuals with SCI regarding what they can achieve physically. Few adverse events were observed: minor skin lesions and irritations were observed; no falls occurred. Conclusions. The device-training for individuals with thoracic and lumbar SCI was effective and safe. All trained individuals achieved technically assisted mobility with the exoskeleton while still needing a close contact guard.
The Effectiveness and Safety of Exoskeletons as Assistive and Rehabilitation Devices in the Treatment of Neurologic Gait Disorders in Patients with Spinal Cord Injury: A Systematic Review. [2020]Study Design Systematic review. Clinical Questions (1) When used as an assistive device, do wearable exoskeletons improve lower extremity function or gait compared with knee-ankle-foot orthoses (KAFOs) in patients with complete or incomplete spinal cord injury? (2) When used as a rehabilitation device, do wearable exoskeletons improve lower extremity function or gait compared with other rehabilitation strategies in patients with complete or incomplete spinal cord injury? (3) When used as an assistive or rehabilitation device, are wearable exoskeletons safe compared with KAFO for assistance or other rehabilitation strategies for rehabilitation in patients with complete or incomplete spinal cord injury? Methods PubMed, Cochrane, and Embase databases and reference lists of key articles were searched from database inception to May 2, 2016, to identify studies evaluating the effectiveness of wearable exoskeletons used as assistive or rehabilitative devices in patients with incomplete or complete spinal cord injury. Results No comparison studies were found evaluating exoskeletons as an assistive device. Nine comparison studies (11 publications) evaluated the use of exoskeletons as a rehabilitative device. The 10-meter walk test velocity and Spinal Cord Independence Measure scores showed no difference in change from baseline among patients undergoing exoskeleton training compared with various comparator therapies. The remaining primary outcome measures of 6-minute walk test distance and Walking Index for Spinal Cord Injury I and II and Functional Independence Measure-Locomotor scores showed mixed results, with some studies indicating no difference in change from baseline between exoskeleton training and comparator therapies, some indicating benefit of exoskeleton over comparator therapies, and some indicating benefit of comparator therapies over exoskeleton. Conclusion There is no data to compare locomotion assistance with exoskeleton versus conventional KAFOs. There is no consistent benefit from rehabilitation using an exoskeleton versus a variety of conventional methods in patients with chronic spinal cord injury. Trials comparing later-generation exoskeletons are needed.
Initial Outcomes from a Multicenter Study Utilizing the Indego Powered Exoskeleton in Spinal Cord Injury. [2019]Objective: To assess safety and mobility outcomes utilizing the Indego powered exoskeleton in indoor and outdoor walking conditions with individuals previously diagnosed with a spinal cord injury (SCI). Methods: We conducted a multicenter prospective observational cohort study in outpatient clinics associated with 5 rehabilitation hospitals. A convenience sample of nonambulatory individuals with SCI (N = 32) completed an 8-week training protocol consisting of walking training 3 times per week utilizing the Indego powered exoskeleton in indoor and outdoor conditions. Participants were also trained in donning/doffing the exoskeleton during each session. Safety measures such as adverse events (AEs) were monitored and reported. Time and independence with donning/doffing the exoskeleton as well as walking outcomes to include the 10-meter walk test (10MWT), 6-minute walk test (6MWT), Timed Up & Go test (TUG), and 600-meter walk test were evaluated from midpoint to final evaluations. Results: All 32 participants completed the training protocol with limited device-related AEs, which resulted in no interruption in training. The majority of participants in this trial were able to don and doff the Indego independently. Final walking speed ranged from 0.19 to 0.55 m/s. Final average indoor and outdoor walking speeds among all participants were 0.37 m/s (SD = 0.08, 0.09, respectively), after 8 weeks of training. Significant (p < .05) improvements were noted between midpoint and final gait speeds in both indoor and outdoor conditions. Average walking endurance also improved among participants after training. Conclusion: The Indego was shown to be safe for providing upright mobility to 32 individuals with SCIs who were nonambulatory. Improvements in speed and independence were noted with walking in indoor and outdoor conditions as well as with donning/doffing the exoskeleton.
Exoskeletal-Assisted Walking During Acute Inpatient Rehabilitation Leads to Motor and Functional Improvement in Persons With Spinal Cord Injury: A Pilot Study. [2020]To explore the potential effects of incorporating exoskeletal-assisted walking (EAW) into spinal cord injury (SCI) acute inpatient rehabilitation (AIR) on facilitating functional and motor recovery when compared with standard of care AIR.
Exoskeleton Walk Training in Paralyzed Individuals Benefits From Transcutaneous Lumbar Cord Tonic Electrical Stimulation. [2020]In recent years, advanced technologies featuring wearable powered exoskeletons and neuromodulation of lumbosacral spinal networks have been developed to facilitate stepping and promote motor recovery in humans with paralysis. Here we studied a combined effect of spinal cord electrical stimulation (SCES) and exoskeleton walk training (EWT) during an intensive 2-week rehabilitative protocol in spinal cord injury individuals (n = 19, American Spinal Injury Association Impairment Scale (AIS) A-11, B-5, C-3). The purpose of this study was to evaluate the compatibility of methods and to explore the main effects of combined SCES and EWT. All participants had a chronic state of paralysis (1-11 years after trauma). In addition, in the control group (n = 16, AIS A-7, B-5, C-4), we performed EWT without SCES. For EWT, we used a powered exoskeleton (ExoAtlet), while stability was assisted by crutches, with automatic arrest of stepping if excessive torques were detected. SCES was applied to the level of the mid-lumbar cord over the Th12 vertebra at 1 or 3 pulses/s (4 individuals with severe spasticity were also stimulated in an anti-spastic mode 67 pulses/s). The vertical component of the ground reaction force was recorded using the F-Scan system at the onset and after training with SCES. EWT with SCES significantly increased the foot loading forces, could decrease their asymmetry and 8 out of 19 subjects improved their Hauser Ambulation Index. The anti-spastic mode of stimulation also allowed individuals with severe spasticity to walk with the aid of the exoskeleton. Participants reported facilitation when walking with SCES, paresthesia in leg muscles and new non-differential sensation of passive motion in leg joints. Neurological examination showed an increase of tactile (7) and/or pain (7) sensation and an increase of the AIS motor scale in 9 individuals, including both incomplete and complete paralysis. Improvements in the neurological scores were, however, limited in the control group (EWT without SCES). The results suggest that SCES may facilitate training and walking in the exoskeleton by activating the locomotor networks and augmenting compensative sensitivity.
A systematic review of the determinants of implementation of a locomotor training program using a powered exoskeleton for individuals with a spinal cord injury. [2023]Wearable powered exoskeletons represent a promising rehabilitation tool for locomotor training in various populations, including in individuals with a spinal cord injury. The lack of clear evidence on how to implement a locomotor powered exoskeleton training program raises many challenges for patients, clinicians and organizations.