Exoskeleton Neurogenic Bowel Dysfunction Study

The University of Hong Kong (HKU)

Status: Unknown

Conditions: Neurogenic Bowel; Spinal Cord Injuries

Treatments: Device: Exoskeleton training with Ekso NR

Study type: Interventional

Funder types: Other

Identifiers

NCT05176327

UW 21-406

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Device: Exoskeleton training with Ekso NR

Control

Active Comparator group

Description:

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.

Treatment:

Device: Exoskeleton training with Ekso NR