EFFECTS OF ROBOTIC TRAINING ON VASCULAR HEALTH OF INDIVIDUALS WITH SCI

NCT03611803 | Completed DMC

• 1 other identifier: Faulkner_Ekso_SCI
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise; Spinal Cord Injuries

Keywords

Robotic-assisted gait training; SCI; Ambulatory activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Central Blood pressure

  Assessed at Baseline and Through study completion (1 week after baseline).

• Change in Peripheral blood pressure

  Assessed at Baseline and Through study completion (1 week after baseline).

Study Arms (2)

Ekso Group

EXPERIMENTAL

Device: Physiotherapy + Robotic-device

Control

ACTIVE COMPARATOR

Other: Physiotherapy only

Interventions

Physiotherapy + Robotic-device DEVICE

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

Ekso Group

Physiotherapy only OTHER

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

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.).

Sponsors & Collaborators

• University of Winchester: lead
• Hobbs Rehabilitation: collaborator

Study Sites (1)

Centre for Sport

Winchester, Hampshire, SO22 4NR, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31525137 DERIVED

MeSH Terms

Conditions

Motor Activity; Spinal Cord Injuries

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Behavior; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: August 2, 2018
• Study Start: August 10, 2018
• Primary Completion: September 28, 2018
• Study Completion: September 28, 2018
• Last Updated: October 2, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)