Exoskeleton Neurogenic Bowel Dysfunction Study

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05176327
• Other study ID #: UW 21-406
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 2023

Study information

• Verified date: December 2021
• Source: The University of Hong Kong
• Contact: Chor-yin Lam, MBBS
• Phone: +852-2255-5228
• Email: lamclive[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Diseases
• Neurogenic Bowel
• Spinal Cord Injuries

Intervention

Device:
• Exoskeleton training with Ekso NR
Walking exercise with Ekso NR

Locations

Country	Name	City	State
Hong Kong	MacLehose Medical Rehabilitation Centre	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Hospital Authority, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (17)

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. — View Citation

Baunsgaard CB, Nissen UV, Brust AK, Frotzler A, Ribeill C, Kalke YB, León N, Gómez B, Samuelsson K, Antepohl W, Holmström U, Marklund N, Glott T, Opheim A, Penalva JB, Murillo N, Nachtegaal J, Faber W, Biering-Sørensen F. Exoskeleton gait training after s — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Glickman S, Kamm MA. Bowel dysfunction in spinal-cord-injury patients. Lancet. 1996 Jun 15;347(9016):1651-3. — View Citation

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. — View Citation

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. — View Citation

Krogh K, Christensen P, Sabroe S, Laurberg S. Neurogenic bowel dysfunction score. Spinal Cord. 2006 Oct;44(10):625-31. Epub 2005 Dec 13. — View Citation

Krogh K, Emmanuel A, Perrouin-Verbe B, Korsten MA, Mulcahey MJ, Biering-Sørensen 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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