Exoskeleton Neurogenic Bowel Dysfunction Study
Study Details
Study Description
Brief Summary
The purpose of the study is to assess the effects of exoskeleton training on neurogenic bowel disorders in spinal cord injury/ disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention 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
Walking exercise with Ekso NR
|
| Active Comparator: Control 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
Walking exercise with Ekso NR
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
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:
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Unstable cardiovascular or pulmonary conditions
-
Untreated thromboembolic events
-
Untreated psychiatric disorders
-
History of malignancy
-
Any contra-indications for exoskeleton training
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MacLehose Medical Rehabilitation Centre | Hong Kong | Hong Kong |
Sponsors and Collaborators
- The University of Hong Kong
- Hospital Authority, Hong Kong
Investigators
- Principal Investigator: Chor-yin Lam, MBBS, The University of Hong Kong
Study Documents (Full-Text)
None provided.More Information
Publications
- American Spinal Injury Association. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) (Revised 2019). 2019.
- ASIA and ISCoS International Standards Committee. The 2019 revision of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)-What's new? Spinal Cord. 2019 Oct;57(10):815-817. doi: 10.1038/s41393-019-0350-9. Epub 2019 Sep 17.
- Benevento BT, Sipski ML. Neurogenic bladder, neurogenic bowel, and sexual dysfunction in people with spinal cord injury. Phys Ther. 2002 Jun;82(6):601-12. Review.
- Bloemen-Vrencken JH, Post MW, Hendriks JM, De Reus EC, De Witte LP. Health problems of persons with spinal cord injury living in the Netherlands. Disabil Rehabil. 2005 Nov 30;27(22):1381-9.
- Burns AS, St-Germain D, Connolly M, Delparte JJ, Guindon A, Hitzig SL, Craven BC. Phenomenological study of neurogenic bowel from the perspective of individuals living with spinal cord injury. Arch Phys Med Rehabil. 2015 Jan;96(1):49-55. doi: 10.1016/j.apmr.2014.07.417. Epub 2014 Aug 27.
- Esquenazi A, Talaty M, Packel A, Saulino M. The ReWalk powered exoskeleton to restore ambulatory function to individuals with thoracic-level motor-complete spinal cord injury. Am J Phys Med Rehabil. 2012 Nov;91(11):911-21. doi: 10.1097/PHM.0b013e318269d9a3.
- Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149.
- Glickman S, Kamm MA. Bowel dysfunction in spinal-cord-injury patients. Lancet. 1996 Jun 15;347(9016):1651-3.
- Kinnett-Hopkins D, Mummidisetty CK, Ehrlich-Jones L, Crown D, Bond RA, Applebaum MH, Jayaraman A, Furbish C, Forrest G, Field-Fote E, Heinemann AW. Users with spinal cord injury experience of robotic Locomotor exoskeletons: a qualitative study of the benefits, limitations, and recommendations. J Neuroeng Rehabil. 2020 Sep 11;17(1):124. doi: 10.1186/s12984-020-00752-9.
- Miller LE, Zimmermann AK, Herbert WG. Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis. Med Devices (Auckl). 2016 Mar 22;9:455-66. doi: 10.2147/MDER.S103102. eCollection 2016. Review.
- Stiens SA, Bergman SB, Goetz LL. Neurogenic bowel dysfunction after spinal cord injury: clinical evaluation and rehabilitative management. Arch Phys Med Rehabil. 1997 Mar;78(3 Suppl):S86-102. Review.
- Zeilig G, Weingarden H, Zwecker M, Dudkiewicz I, Bloch A, Esquenazi A. Safety and tolerance of the ReWalk™ exoskeleton suit for ambulation by people with complete spinal cord injury: a pilot study. J Spinal Cord Med. 2012 Mar;35(2):96-101. doi: 10.1179/2045772312Y.0000000003. Epub 2012 Feb 7.
- UW 21-406