Exoskeleton Neurogenic Bowel Dysfunction Study

May 14, 2026 updated by: The University of Hong Kong

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • MacLehose Medical Rehabilitation Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in Neurogenic Bowel Dysfunction (NBD) score in International SCI bowel function basic data set (version 2.0)
Time Frame: 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.
Week 0 (Pre-training), Week 8, , Week 16, week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in defaecation time (DT)
Time Frame: Week 0 (Pre-training), Week 8, , Week 16, week 24
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
Time Frame: Week 0 (Pre-training), Week 8, , Week 16, week 24
The change in number of times of bowel incontinence in the week before
Week 0 (Pre-training), Week 8, , Week 16, week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Hospital Authority, Hong Kong

Investigators

  • Principal Investigator: Chor-yin Lam, MBBS, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

January 3, 2022

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 21-406

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Sharing of the study protocol, SAP and ICF will be done on request by email to the PI

IPD Sharing Time Frame

From 1 Jan 2024, for a period of 3 years

IPD Sharing Access Criteria

On request by email to the PI

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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