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Exoskeleton Neurogenic Bowel Dysfunction Study

Primary Purpose

Spinal Cord Injuries, Neurogenic Bowel

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Exoskeleton training with Ekso NR
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring spinal cord injuries, neurogenic bowel, exoskeleton, rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • MacLehose Medical Rehabilitation CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

The change in Neurogenic Bowel Dysfunction (NBD) score in International SCI bowel function basic data set (version 2.0)
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

The change in defaecation time (DT)
The change in average time in minutes to complete defaecation in one week
The change in frequency of bowel incontinence episodes
The change in number of times of bowel incontinence in the week before

Full Information

First Posted
December 14, 2021
Last Updated
May 17, 2022
Sponsor
The University of Hong Kong
Collaborators
Hospital Authority, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05176327
Brief Title
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
Collaborators
Hospital Authority, Hong Kong

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Neurogenic Bowel
Keywords
spinal cord injuries, neurogenic bowel, exoskeleton, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Exoskeleton training with Ekso NR
Intervention Description
Walking exercise with Ekso NR
Primary Outcome Measure Information:
Title
The change in Neurogenic Bowel Dysfunction (NBD) score in International SCI bowel function basic data set (version 2.0)
Description
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.
Time Frame
Week 0 (Pre-training), Week 8, , Week 16, week 24
Secondary Outcome Measure Information:
Title
The change in defaecation time (DT)
Description
The change in average time in minutes to complete defaecation in one week
Time Frame
Week 0 (Pre-training), Week 8, , Week 16, week 24
Title
The change in frequency of bowel incontinence episodes
Description
The change in number of times of bowel incontinence in the week before
Time Frame
Week 0 (Pre-training), Week 8, , Week 16, week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chor-yin Lam, MBBS
Phone
+852-2255-5228
Email
lamclive@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chor-yin Lam, MBBS
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
MacLehose Medical Rehabilitation Centre
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chor-yin Lam, MBBS
Phone
+852-2255-5228
Email
lamclive@hku.hk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
8642958
Citation
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Benevento BT, Sipski ML. Neurogenic bladder, neurogenic bowel, and sexual dysfunction in people with spinal cord injury. Phys Ther. 2002 Jun;82(6):601-12.
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Stiens SA, Bergman SB, Goetz LL. Neurogenic bowel dysfunction after spinal cord injury: clinical evaluation and rehabilitative management. Arch Phys Med Rehabil. 1997 Mar;78(3 Suppl):S86-102. doi: 10.1016/s0003-9993(97)90416-0.
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Exoskeleton Neurogenic Bowel Dysfunction Study

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