Exoskeleton Neurogenic Bowel Dysfunction Study

NCT05176327 | Unknown FDA Device

• 1 other identifier: UW 21-406
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spinal Cord Injuries; Neurogenic Bowel

Keywords

spinal cord injuries; neurogenic bowel; exoskeleton; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The change in defaecation time (DT)

  Week 0 (Pre-training), Week 8, , Week 16, week 24

• The change in frequency of bowel incontinence episodes

  Week 0 (Pre-training), Week 8, , Week 16, week 24

Study Arms (2)

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.

Device: Exoskeleton training with Ekso NR

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.

Device: Exoskeleton training with Ekso NR

Interventions

Exoskeleton training with Ekso NR DEVICE

Walking exercise with Ekso NR

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unstable cardiovascular or pulmonary conditions
• Untreated thromboembolic events
• Untreated psychiatric disorders
• History of malignancy
• Any contra-indications for exoskeleton training

Sponsors & Collaborators

• The University of Hong Kong: lead
• Hospital Authority, Hong Kong: collaborator

Study Sites (1)

MacLehose Medical Rehabilitation Centre

Hong Kong, Hong Kong

RECRUITING

Related Publications (17)

• 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.

  PMID: 8642958 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.

  PMID: 16321920 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.

  PMID: 25172370 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.

  PMID: 12036401 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.

  PMID: 9084372 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.

  PMID: 32917287 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.

  PMID: 27042146 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.

  PMID: 23085703 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.

  PMID: 22333043 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.

  PMID: 31530900 BACKGROUND

• American Spinal Injury Association. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) (Revised 2019). 2019.

  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.

  PMID: 19897823 BACKGROUND

• 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.

  PMID: 26330842 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.

  PMID: 30183055 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.

  PMID: 28195229 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.

  PMID: 16344850 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.

  PMID: 26157223 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries; Neurogenic Bowel

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Chor-yin Lam, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chor-yin Lam, MBBS

CONTACT

+852-2255-5228; lamclive@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 4, 2022
• Study Start: January 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 18, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From 1 Jan 2024, for a period of 3 years
• Access Criteria: On request by email to the PI

Locations

HK (1)