Neurogenic Bowel, Spinal Cord Injuries
Conditions
Keywords
spinal cord injuries, neurogenic bowel, exoskeleton, rehabilitation
Brief summary
The purpose of the study is to assess the effects of exoskeleton training on neurogenic bowel disorders in spinal cord injury/ disease.
Detailed description
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.
Interventions
DEVICEExoskeleton training with Ekso NR
Walking exercise with Ekso NR
Sponsors
The University of Hong Kong
Hospital Authority, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. SCI/D for a duration ≥ 12 months 2. Neurological level of injury (NLI) C4 to L3 as defined in the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) 2019 revision 3. Bowel opening via anal route or stoma 4. Stable medical condition 5. Stable mental condition 6. No active painful musculoskeletal problems like fracture, infection, pressure injury, contracture or uncontrolled spasticity 7. Age ≥ 18 years old 8. Body height 150 - 188cm
Exclusion criteria
1. Unstable cardiovascular or pulmonary conditions 2. Untreated thromboembolic events 3. Untreated psychiatric disorders 4. History of malignancy 5. Any contra-indications for exoskeleton training
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in Neurogenic Bowel Dysfunction (NBD) score in International SCI bowel function basic data set (version 2.0) | Week 0 (Pre-training), Week 8, , Week 16, week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change in frequency of bowel incontinence episodes | Week 0 (Pre-training), Week 8, , Week 16, week 24 | The change in number of times of bowel incontinence in the week before |
| The change in defaecation time (DT) | Week 0 (Pre-training), Week 8, , Week 16, week 24 | The change in average time in minutes to complete defaecation in one week |
Countries
Hong Kong
Contacts
PRINCIPAL_INVESTIGATORChor-yin Lam, MBBS
The University of Hong Kong
Outcome results
None listed