EFFECTS OF ROBOTIC TRAINING ON VASCULAR HEALTH OF INDIVIDUALS WITH SCI

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611803
• Other study ID #: Faulkner_Ekso_SCI
• Status: Completed
• Phase: N/A
• Start date: August 10, 2018
• Est. completion date: September 28, 2018

Study information

• Verified date: October 2018
• Source: University of Winchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 28, 2018
• Est. primary completion date: September 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.).

Related Conditions & MeSH terms

• Exercise
• Spinal Cord Injuries

Intervention

Device:
• Physiotherapy + Robotic-device
Daily use of an exoskeleton (robotic-device) on 5 successive days as well as daily physiotherapy sessions

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

Locations

Country	Name	City	State
United Kingdom	Centre for Sport	Winchester	Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Winchester	Hobbs Rehabilitation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Augmentation index	Measured on the left, upper arm, in duplicate and following a 20 minute supine rest using a SphygmoCor XCEL.	Assessed at Baseline and Through study completion (1 week after baseline).
Secondary	Change in Central Blood pressure	Measured on the left, upper arm, in duplicate and following a 20 minute supine rest using a SphygmoCor XCEL.	Assessed at Baseline and Through study completion (1 week after baseline).
Secondary	Change in Peripheral blood pressure	Measured on the left, upper arm, in duplicate and following a 20 minute supine rest using a SphygmoCor XCEL.	Assessed at Baseline and Through study completion (1 week after baseline).