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Completed

NCT Number: NCT05176327

Exoskeleton Neurogenic Bowel Dysfunction Study

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MacLehose Medical Rehabilitation Centre

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Exoskeleton training with Ekso NR

Device

Walking exercise with Ekso NR

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Hospital Authority, Hong Kong

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 4, 2022
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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