Clinical trial NCT05176327: Exoskeleton Neurogenic Bowel Dysfunction Study
Official title: A Pilot Randomized Controlled Study of the Effects of Exoskeleton Training on Neurogenic Bowel Dysfunction in Spinal Cord Injury/ Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Neurogenic Bowel
Keywords: spinal cord injuries
neurogenic bowel
exoskeleton
rehabilitation
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hospital Authority, Hong Kong
First posted: 2022-01-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The change in Neurogenic Bowel Dysfunction (NBD) score in International SCI bowel function basic data set (version 2.0)
timeFrame: Week 0 (Pre-training), Week 8, , Week 16, week 24
Secondary outcomes:
measure: The change in defaecation time (DT)
timeFrame: Week 0 (Pre-training), Week 8, , Week 16, week 24
measure: The change in frequency of bowel incontinence episodes
timeFrame: Week 0 (Pre-training), Week 8, , Week 16, week 24
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: MacLehose Medical Rehabilitation Centre
Study officials:
affiliation: The University of Hong Kong
name: Chor-yin Lam, MBBS
role: PRINCIPAL_INVESTIGATOR
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