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Completed

NCT Number: NCT03611803

EFFECTS OF ROBOTIC TRAINING ON VASCULAR HEALTH OF INDIVIDUALS WITH SCI

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Sport

Winchester, Hampshire, SO22 4NR, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Physiotherapy + Robotic-device

Device

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

physiotherapy only

Other

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

Primary outcomes

  1. Change in Augmentation index

    Time frame: Assessed 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 outcomes

  1. Change in Central Blood pressure

    Time frame: Assessed 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.

  2. Change in Peripheral blood pressure

    Time frame: Assessed 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.

Sponsors and collaborators

Lead sponsor

University of Winchester

Other

Collaborators

  • Hobbs Rehabilitation

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 2, 2018
Registry last updated
Oct 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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