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EFFECTS OF ROBOTIC TRAINING ON VASCULAR HEALTH OF INDIVIDUALS WITH SCI

EFFECTS OF ROBOTIC-ASSISTED GAIT TRAINING ON THE VASCULAR HEALTH OF INDIVIDUALS WITH SPINAL CORD INJURY

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03611803
Enrollment
12
Registered
2018-08-02
Start date
2018-08-10
Completion date
2018-09-28
Last updated
2018-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise, Spinal Cord Injuries

Keywords

Robotic-assisted gait training, SCI, Ambulatory activity

Brief summary

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.

Detailed 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.

Interventions

DEVICEPhysiotherapy + Robotic-device

Daily use of an exoskeleton (robotic-device) on 5 successive days as well as daily physiotherapy sessions

Participants will engage in daily physiotherapy sessions (without the exoskeleton) and/or home-based sit-to-stand exercises

Sponsors

Hobbs Rehabilitation
CollaboratorOTHER
University of Winchester
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.).

Design outcomes

Primary

MeasureTime frameDescription
Change in Augmentation indexAssessed at Baseline and Through study completion (1 week after baseline).Measured on the left, upper arm, in duplicate and following a 20 minute supine rest using a SphygmoCor XCEL.

Secondary

MeasureTime frameDescription
Change in Central Blood pressureAssessed at Baseline and Through study completion (1 week after baseline).Measured on the left, upper arm, in duplicate and following a 20 minute supine rest using a SphygmoCor XCEL.
Change in Peripheral blood pressureAssessed at Baseline and Through study completion (1 week after baseline).Measured on the left, upper arm, in duplicate and following a 20 minute supine rest using a SphygmoCor XCEL.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026