EFFECTS OF ROBOTIC TRAINING ON VASCULAR HEALTH OF INDIVIDUALS WITH SCI
Primary Purpose
Exercise, Spinal Cord Injuries
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Physiotherapy + Robotic-device
Physiotherapy only
Sponsored by
About this trial
This is an interventional basic science trial for Exercise focused on measuring Robotic-assisted gait training, SCI, Ambulatory activity
Eligibility Criteria
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.).
Sites / Locations
- Centre for Sport
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ekso Group
Control
Arm Description
Outcomes
Primary Outcome Measures
Change in Augmentation index
Measured on the left, upper arm, in duplicate and following a 20 minute supine rest using a SphygmoCor XCEL.
Secondary Outcome Measures
Change in Central Blood pressure
Measured on the left, upper arm, in duplicate and following a 20 minute supine rest using a SphygmoCor XCEL.
Change in Peripheral blood pressure
Measured on the left, upper arm, in duplicate and following a 20 minute supine rest using a SphygmoCor XCEL.
Full Information
NCT ID
NCT03611803
First Posted
June 28, 2018
Last Updated
October 1, 2018
Sponsor
University of Winchester
Collaborators
Hobbs Rehabilitation
1. Study Identification
Unique Protocol Identification Number
NCT03611803
Brief Title
EFFECTS OF ROBOTIC TRAINING ON VASCULAR HEALTH OF INDIVIDUALS WITH SCI
Official Title
EFFECTS OF ROBOTIC-ASSISTED GAIT TRAINING ON THE VASCULAR HEALTH OF INDIVIDUALS WITH SPINAL CORD INJURY
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 10, 2018 (Actual)
Primary Completion Date
September 28, 2018 (Actual)
Study Completion Date
September 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Winchester
Collaborators
Hobbs Rehabilitation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise, Spinal Cord Injuries
Keywords
Robotic-assisted gait training, SCI, Ambulatory activity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ekso Group
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Physiotherapy + Robotic-device
Intervention Description
Daily use of an exoskeleton (robotic-device) on 5 successive days as well as daily physiotherapy sessions
Intervention Type
Other
Intervention Name(s)
Physiotherapy only
Intervention Description
Participants will engage in daily physiotherapy sessions (without the exoskeleton) and/or home-based sit-to-stand exercises
Primary Outcome Measure Information:
Title
Change in Augmentation index
Description
Measured on the left, upper arm, in duplicate and following a 20 minute supine rest using a SphygmoCor XCEL.
Time Frame
Assessed at Baseline and Through study completion (1 week after baseline).
Secondary Outcome Measure Information:
Title
Change in Central Blood pressure
Description
Measured on the left, upper arm, in duplicate and following a 20 minute supine rest using a SphygmoCor XCEL.
Time Frame
Assessed at Baseline and Through study completion (1 week after baseline).
Title
Change in Peripheral blood pressure
Description
Measured on the left, upper arm, in duplicate and following a 20 minute supine rest using a SphygmoCor XCEL.
Time Frame
Assessed at Baseline and Through study completion (1 week after baseline).
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.).
Facility Information:
Facility Name
Centre for Sport
City
Winchester
State/Province
Hampshire
ZIP/Postal Code
SO22 4NR
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31525137
Citation
Faulkner J, Martinelli L, Cook K, Stoner L, Ryan-Stewart H, Paine E, Hobbs H, Lambrick D. Effects of robotic-assisted gait training on the central vascular health of individuals with spinal cord injury: A pilot study. J Spinal Cord Med. 2021 Mar;44(2):299-305. doi: 10.1080/10790268.2019.1656849. Epub 2019 Sep 16.
Results Reference
derived
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EFFECTS OF ROBOTIC TRAINING ON VASCULAR HEALTH OF INDIVIDUALS WITH SCI
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