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| Name | Class |
|---|---|
| Hospital Authority, Hong Kong | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Control | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exoskeleton training with Ekso NR | Device | Walking exercise with Ekso NR |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chor-yin Lam, MBBS | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MacLehose Medical Rehabilitation Centre | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8642958 | Background | Glickman S, Kamm MA. Bowel dysfunction in spinal-cord-injury patients. Lancet. 1996 Jun 15;347(9016):1651-3. doi: 10.1016/s0140-6736(96)91487-7. | |
| 16321920 | Background | 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. doi: 10.1080/09638280500164685. |
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Sharing of the study protocol, SAP and ICF will be done on request by email to the PI
From 1 Jan 2024, for a period of 3 years
On request by email to the PI
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D055496 | Neurogenic Bowel |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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The change in number of times of bowel incontinence in the week before
| Week 0 (Pre-training), Week 8, , Week 16, week 24 |
| 25172370 | Background | 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. |
| 12036401 | Background | 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. |
| 9084372 | Background | 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. doi: 10.1016/s0003-9993(97)90416-0. |
| 32917287 | Background | 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. |
| 27042146 | Background | 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. |
| 23085703 | Background | 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. |
| 22333043 | Background | 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. |
| 31530900 | Background | 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. No abstract available. |
| Background | American Spinal Injury Association. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) (Revised 2019). 2019. |
| 19897823 | Background | 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. |
| 26330842 | Result | Ozisler Z, Koklu K, Ozel S, Unsal-Delialioglu S. Outcomes of bowel program in spinal cord injury patients with neurogenic bowel dysfunction. Neural Regen Res. 2015 Jul;10(7):1153-8. doi: 10.4103/1673-5374.160112. |
| 30183055 | Result | Baunsgaard CB, Nissen UV, Brust AK, Frotzler A, Ribeill C, Kalke YB, Leon N, Gomez B, Samuelsson K, Antepohl W, Holmstrom U, Marklund N, Glott T, Opheim A, Penalva JB, Murillo N, Nachtegaal J, Faber W, Biering-Sorensen F. Exoskeleton gait training after spinal cord injury: An exploratory study on secondary health conditions. J Rehabil Med. 2018 Sep 28;50(9):806-813. doi: 10.2340/16501977-2372. |
| 28195229 | Result | Krogh K, Emmanuel A, Perrouin-Verbe B, Korsten MA, Mulcahey MJ, Biering-Sorensen F. International spinal cord injury bowel function basic data set (Version 2.0). Spinal Cord. 2017 Jul;55(7):692-698. doi: 10.1038/sc.2016.189. Epub 2017 Feb 14. |
| 16344850 | Result | Krogh K, Christensen P, Sabroe S, Laurberg S. Neurogenic bowel dysfunction score. Spinal Cord. 2006 Oct;44(10):625-31. doi: 10.1038/sj.sc.3101887. Epub 2005 Dec 13. |
| 26157223 | Result | Huang Q, Yu L, Gu R, Zhou Y, Hu C. Effects of robot training on bowel function in patients with spinal cord injury. J Phys Ther Sci. 2015 May;27(5):1377-8. doi: 10.1589/jpts.27.1377. Epub 2015 May 26. |
| D014947 | Wounds and Injuries |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |