Exoskeleton Neurogenic Bowel Dysfunction Study

Not Applicable

• Conditions: Neurogenic Bowel; Spinal Cord Injuries
• Interventions: Device: Exoskeleton training with Ekso NR

• Registration Number: NCT05176327
• Lead Sponsor: The University of Hong Kong

Brief Summary

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

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-14
• Study Start: 2022-01-01
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-04
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-18
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Exoskeleton training with Ekso NR	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	Exoskeleton training with Ekso NR	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.

Primary Outcome Measures

Name	Time	Method
The change in Neurogenic Bowel Dysfunction (NBD) score in International SCI bowel function basic data set (version 2.0)	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 Outcome Measures

Name	Time	Method
The change in frequency of bowel incontinence episodes	Week 0 (Pre-training), Week 8, , Week 16, week 24	The change in number of times of bowel incontinence in the week before
The change in defaecation time (DT)	Week 0 (Pre-training), Week 8, , Week 16, week 24	The change in average time in minutes to complete defaecation in one week

Trial Locations

Locations (1)

MacLehose Medical Rehabilitation Centre; 🇭🇰 Hong Kong, Hong Kong