Clinical trial NCT05401734: Robot Assisted Gait Training in Persons With a Spinal Cord Injury
Official title: Robot Assisted Gait Training in Persons With a Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SCI - Spinal Cord Injury
Lead sponsor: Thomas More Kempen
Sponsor class: OTHER
Collaborators: name: AZ Herentals
First posted: 2022-06-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 50 persons with a SCI will be included in the study. All participants are persons included in the RAGT program organized by the To Walk Again Postrehabilitation Centre. The recruitment will be performed by word of mouth. Participants utilizing the Eksoskeleton at the To Walk Again Postrehabilitation Centre will be asked if they are willing to participate in this study. Participation will be strictly voluntary

Brief 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.

Eligibility criteria: Inclusion Criteria:

* SCI
* Bone density

Exclusion Criteria:

* osteoporosis
* length more than 2 meter

Primary outcomes:
measure: ROM (Range of Motion)
timeFrame: 3 months
measure: ROM (Range of Motion)
timeFrame: 6 months
measure: ROM (Range of Motion)
timeFrame: 9 months
measure: ROM (Range of Motion)
timeFrame: 12 months
measure: ROM (Range of Motion)
timeFrame: 15 months
measure: ROM (Range of Motion)
timeFrame: 18 months
measure: ROM (Range of Motion)
timeFrame: 21 months
measure: ROM (Range of Motion)
timeFrame: 24 months
measure: WHOQOL
timeFrame: 3 months
measure: WHOQOL
timeFrame: 6 months
measure: WHOQOL
timeFrame: 9 months
measure: WHOQOL
timeFrame: 12 months
measure: WHOQOL
timeFrame: 15 months
measure: WHOQOL
timeFrame: 18 months
measure: WHOQOL
timeFrame: 21 months
measure: WHOQOL
timeFrame: 24 months
measure: IPA
timeFrame: 3 months
measure: IPA
timeFrame: 6 months
measure: IPA
timeFrame: 9 months
measure: IPA
timeFrame: 12 months
measure: IPA
timeFrame: 15 months
measure: IPA
timeFrame: 18 months
measure: IPA
timeFrame: 21 months
measure: IPA
timeFrame: 24 months
measure: Bowel and bladder function
timeFrame: 3 months
measure: Bowel and bladder function
timeFrame: 6 months
measure: Bowel and bladder function
timeFrame: 9 months
measure: Bowel and bladder function
timeFrame: 12 months
measure: Bowel and bladder function
timeFrame: 15 months
measure: Bowel and bladder function
timeFrame: 18 months
measure: Bowel and bladder function
timeFrame: 21 months
measure: Bowel and bladder function
timeFrame: 24 months
Secondary outcomes:
measure: Medication
timeFrame: 3 months
measure: Medication
timeFrame: 6 months
measure: Medication
timeFrame: 9 months
measure: Medication
timeFrame: 12 months
measure: Medication
timeFrame: 15 months
measure: Medication
timeFrame: 18 months
measure: Medication
timeFrame: 21 months
measure: Medication
timeFrame: 24 months
Other outcomes:
Locations:
city: Geel
country: Belgium
facility: De Maesschalck Lieven
state: Antwerp
Study officials:
References: