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EFFECTS OF ROBOTIC TRAINING ON VASCULAR HEALTH OF INDIVIDUALS WITH SCI

U

University of Winchester

Status

Completed

Conditions

Spinal Cord Injuries
Exercise

Treatments

Other: Physiotherapy only
Device: Physiotherapy + Robotic-device

Study type

Interventional

Funder types

Other

Identifiers

NCT03611803
Faulkner_Ekso_SCI

Details and patient eligibility

About

Robotic devices may be used to help the gait and balance of individuals with Spinal Cord Injury (SCI). However, as such devices may allow individuals to engage in physical activity in an upright position, there may be significant benefit on the vascular health of patients with SCI. This study will assess the effect of a robotic-assisted gait-training (exoskeleton) program on central and peripheral hemodynamic markers in people with SCI.

Full description

Individuals with spinal cord injury (SCI) have an accelerated trajectory of aging in the cardiovascular system compared with same-age individuals in the general population,and accordingly, have a higher rate of cardiovascular mortality. For example, SCI is significantly associated with an increased risk of heart disease (odds ratio = 2.72) and stroke (odds ratio = 3.72).This is at least partially attributed to their impaired blood pressure regulation as a consequence of the autonomic nervous system dysfunction, physical inactivity and increased sedentary time. As such, there is a pressing need to identify practical strategies for increasing physical activity and decreasing sedentary time.

Robotic-assisted gait training (RGT) is used in the rehabilitation of patients with SCI, although individual access is often limited and infrequent. Task-specific stepping practice enhances the afferent feedback associated with normal locomotion and can induce plasticity in the involved motor centers. As RGT enables practitioners to increase the intensity and total duration of physical activity whilst maintaining a physiological gait pattern, there may be significant benefit for people with SCI to manage their risk of cardiovascular disease (CVD). This may be evident if an individual with SCI has regular and continued access to such technology. However, there is a paucity of research which has considered the vascular benefit of implementing robotic-assisted training for people with SCI as most research focuses on outcome measures such as gait velocity, gait distance, leg strength, balance and spasticity.Further, while this technology may be practical in terms of application, the cost is currently prohibitive. Thus, prior to advocating resource intensive longitudinal randomized control trials, there's a need for short-term trials using established measures of cardiovascular health.

The purpose of this study is to assess the effect of a RGT (exoskeleton) program on central and peripheral hemodynamic markers in people with SCI.

Enrollment

12 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • SCI diagnosis
  • Meet the manufacturer's guidelines with regards to weight (< 100 kg) and height (between 1.57 m and 1.93 m).
  • Standing at least three times a week with therapist support
  • SCI classified according to the American Spinal Injury Association (ASIA) scale, as either ASIA A (Complete SCI), ASIA B (Sensory incomplete SCI), ASIA C (Motor incomplete SCI)

Exclusion criteria

  • Restricted range of motion in their lower limbs
  • Uncontrolled high levels of muscle spasticity
  • Significant problems managing their blood pressure,
  • Any concerns with their bone density (e.g., osteoporosis, etc.).

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

12 participants in 2 patient groups

Ekso Group
Experimental group
Treatment:
Device: Physiotherapy + Robotic-device
Control
Active Comparator group
Treatment:
Other: Physiotherapy only

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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