NCT05401734

Robot Assisted Gait Training in Persons With a Spinal Cord Injury

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: Thomas More Kempen · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Over the past decade, RAGT has emerged as a promising method for improving ambulation after spinal cord injury (SCI). Early reports of this therapy were very promising, yet a recent study suggested that even though RAGT may improve locomotor ability in the acute SCI population, it appears less functional to more conventional forms of ambulation such as wheelchair propulsion. What most of these studies have neglected to address, however, is the efficacy of RAGT as a therapeutic exercise intervention for the SCI population. Indeed, persons with SCI lead by definition a sedentary lifestyle. This reduced activity can lead to a variety of secondary health complications, including an increased risk for cardiovascular disease, spasticity, altered muscle composition and reduced joint range of motion (ROM), increased risk for pressure sores, reduced bone mineral density, increased risk for osteoporosis, and bladder and bowel dysfunction. In addition, psychological components such as body image, self-esteem, self-efficacy, psychological well-being and quality of life in general may be affected. Consequently, before RAGT is dismissed as an expensive but perhaps not superior alternative to conventional rehabilitation strategies after SCI, the potential effect of this therapy on a variety of health-related outcomes needs to be considered, and the potential physiological and psychological benefits associated with this whole-body upright exercise therapy may justify its use in both the acute and chronic SCI populations. Several investigations have already indicated that regular exposure to RAGT results in some very significant health-related benefits that may decrease the aforementioned risk of secondary health complications. To our knowledge however, longitudinal effect studies in the SCI population have not yet been conducted, and further studies are needed to provide definitive evidence. It can be assumed that such insights may further optimize long-term health benefits, but also the cost-benefit ratio of RAGT. In addition, a detailed analysis of RAGT parameters (walking time, crutch position, forward and lateral center of gravity shift, step length and height, swing phase, walking speed, etc.) and the direct cardiovascular response (heart frequency, blood pressure, blood lactate concentration) to RAGT have not yet been conducted. The purpose of this research project is therefore to investigate the longitudinal effect of RAGT on the psychological well-being (Quality of Life, pain, fatigue), independence in activities of daily living, muscular strength and joint range of motion (ROM), and bladder and bowel function in persons with SCI.

Detailed description

Over the past decade, RAGT has emerged as a promising method for improving ambulation after spinal cord injury (SCI). Early reports of this therapy were very promising, yet a recent study suggested that even though RAGT may improve locomotor ability in the acute SCI population, it appears less functional to more conventional forms of ambulation such as wheelchair propulsion. What most of these studies have neglected to address, however, is the efficacy of RAGT as a therapeutic exercise intervention for the SCI population. Indeed, persons with SCI lead by definition a sedentary lifestyle. This reduced activity can lead to a variety of secondary health complications, including an increased risk for cardiovascular disease, spasticity, altered muscle composition and reduced joint range of motion (ROM), increased risk for pressure sores, reduced bone mineral density, increased risk for osteoporosis, and bladder and bowel dysfunction. In addition, psychological components such as body image, self-esteem, self-efficacy, psychological well-being and quality of life in general may be affected. Consequently, before RAGT is dismissed as an expensive but perhaps not superior alternative to conventional rehabilitation strategies after SCI, the potential effect of this therapy on a variety of health-related outcomes needs to be considered, and the potential physiological and psychological benefits associated with this whole-body upright exercise therapy may justify its use in both the acute and chronic SCI populations. Several investigations have already indicated that regular exposure to RAGT results in some very significant health-related benefits that may decrease the aforementioned risk of secondary health complications. To our knowledge however, longitudinal effect studies in the SCI population have not yet been conducted, and further studies are needed to provide definitive evidence. It can be assumed that such insights may further optimize long-term health benefits, but also the cost-benefit ratio of RAGT. In addition, a detailed analysis of RAGT parameters (walking time, crutch position, forward and lateral center of gravity shift, step length and height, swing phase, walking speed, etc.) and the direct cardiovascular response (heart frequency, blood pressure, blood lactate concentration) to RAGT have not yet been conducted. The purpose of this research project is therefore to investigate the longitudinal effect of RAGT on the psychological well-being (Quality of Life, pain, fatigue), independence in activities of daily living, muscular strength and joint range of motion (ROM), and bladder and bowel function in persons with SCI over a period of 2 years in several cohorts. We will measure every three months. Patients will be asked to fill in the questionnaires 3, 6 9, 12, 15, 18, 21 and 24 months after inclusion. Additionally the patients will we asked to fill in his medication intake in the follow-up system.

Conditions

• SCI - Spinal Cord Injury

Interventions

Type	Name	Description
DEVICE	Observation and follow up measurement	The measured variables include: Questionnaires * Health related quality of life (Health Related Quality of Life Questionnaire) * Physical activity level (Physical Activity Scale for Persons with Impairments and Disabilities) * Walking ability (Walking Index for Spinal Cord Injury) * Independence in activities of daily living (SCIM III Questionnaire) * Pain (International SCI Pain Basic Data Set) * Resilience (Resilience Scale) * Bowel and bladder function (Neurogenic Bowel Dysfunction score, International Consultation on Incontinence Modular Questionnaire - Lower Urinary Tract Symptoms) Measurements: * Muscular strength and joint ROM (Manual Muscle Testing) * Spasticity (Modified Ashworth Scale) * Walking parameters (walking time, crutch position, forward and lateral center of gravity shift, step length and height, swing phase, walking speed) * Cardiovascular response (blood pressure, heart frequency, blood lactate concentration and Borg RPE score)

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-10-30
• Completion: 2022-12-31
• First posted: 2022-06-02
• Last updated: 2022-06-02

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated device study