search
Back to results

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
University of Winchester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Exercise focused on measuring Robotic-assisted gait training, SCI, Ambulatory activity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.).

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

First Posted
June 28, 2018
Last Updated
October 1, 2018
Sponsor
University of Winchester
Collaborators
Hobbs Rehabilitation
search

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

Learn more about this trial

EFFECTS OF ROBOTIC TRAINING ON VASCULAR HEALTH OF INDIVIDUALS WITH SCI

We'll reach out to this number within 24 hrs