Exoskeleton Neurogenic Bowel Dysfunction Study

Study Overview
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Brief Summary
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The purpose of the study is to assess the effects of exoskeleton training on neurogenic bowel disorders in spinal cord injury/ disease.

Detailed Description
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After being informed about the study and the potential risks, all patients giving written consents will undergo a medical examination to ensure they are eligible and fit to proceed for the study. Subjects will be randomly assigned to intervention group and control group. Intervention group will receive 2 consecutive courses of exoskeleton training (ET) with twelve 45-minute sessions, each to be completed in 6 to 8 weeks. The total period of training will be 12 to 16 weeks. Control group will receive twelve 45-minute sessions of usual physiotherapy treatment (PT), consisting of maintenance exercise in the first 6 to 8 weeks, and then one course of ET with twelve 45-minute sessions in the following 6 to 8 weeks.

Official Title
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A Pilot Randomized Controlled Study of the Effects of Exoskeleton Training on Neurogenic Bowel Dysfunction in Spinal Cord Injury/ Disease

Conditions
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Spinal Cord Injuries, Neurogenic Bowel

Intervention / Treatment
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* Device: Exoskeleton training with Ekso NR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: SCI/D for a duration ≥ 12 months Neurological level of injury (NLI) C4 to L3 as defined in the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) 2019 revision Bowel opening via anal route or stoma Stable medical condition Stable mental condition No active painful musculoskeletal problems like fracture, infection, pressure injury, contracture or uncontrolled spasticity Age ≥ 18 years old Body height 150 - 188cm Exclusion Criteria: Unstable cardiovascular or pulmonary conditions Untreated thromboembolic events Untreated psychiatric disorders History of malignancy Any contra-indications for exoskeleton training

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Subjects will receive 2 consecutive courses of exoskeleton training with twelve 45-minute sessions, each to be completed in 6 to 8 weeks. The total period of training will be 12 to 16 weeks. | Device: Exoskeleton training with Ekso NR<br>* Walking exercise with Ekso NR<br>|
| Active Comparator: Control<br>Subjects will receive twelve 45-minute sessions of usual physiotherapy treatment, consisting of maintenance exercise in the first 6 to 8 weeks, and then one course of exoskeleton training with twelve 45-minute sessions in the following 6 to 8 weeks. | Device: Exoskeleton training with Ekso NR<br>* Walking exercise with Ekso NR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in Neurogenic Bowel Dysfunction (NBD) score in International SCI bowel function basic data set (version 2.0) | Measurement of the change in the NBD score (0-45, 0-6 Very minor, 7-9 Minor, 10-13 Moderate and 14 or more Severe neurogenic bowel dysfunction) calculated in the data set. | Week 0 (Pre-training), Week 8, , Week 16, week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in defaecation time (DT) | The change in average time in minutes to complete defaecation in one week | Week 0 (Pre-training), Week 8, , Week 16, week 24 | 
| The change in frequency of bowel incontinence episodes | The change in number of times of bowel incontinence in the week before | Week 0 (Pre-training), Week 8, , Week 16, week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord injuries, neurogenic bowel, exoskeleton, rehabilitation