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Robotic Rehabilitation for Spinal Cord Injury (SCI)

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Robotic Functional Rehabilitation system
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Spinal Cord Injury

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with tetraplegia under the care of Department of Orthopaedics and Traumatology, LKS Faculty of Medicine, The University of Hong Kong in Queen Mary Hospital.

Exclusion Criteria:

  • Subjects with any neurological abnormality in brain, intellectual disability or other communication difficulty, subjects with pacemaker or metal implants, subjects with claustrophobia

Sites / Locations

  • The university of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Baseline before robotic functional rehabilitation

post rehabilitation

Arm Description

Baseline spinal cord MRI scan

Those patients will receive 3 months muscle strength enhancement as pre-rehabilitation. Then, we will design robotic hand rehabilitation programme for each individuals. All participants will receive robotic rehabilitation for 1 year. After then, a follow-up spinal cord MRI scan and clinical assessment will evaluate the results of this project.

Outcomes

Primary Outcome Measures

Spinal cord neuroimage
Advanced MRI techniques, such as diffusion tensor imaging (DTI) and functional MRI (fMRI)

Secondary Outcome Measures

Full Information

First Posted
March 20, 2018
Last Updated
May 9, 2023
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03483766
Brief Title
Robotic Rehabilitation for Spinal Cord Injury
Acronym
SCI
Official Title
Individualized Robotic Functional Rehabilitation for Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Individuals with spinal cord injury (SCI) have significant functional loss and poor quality of life. Individuals with cervical SCI are suffering much worse sickness within the SCI population. Tetraplegia resulting from cervical SCI bring a formidable emotional, physical, and financial burden in our society. Hand function is especially important to people with tetraplegia. Hand function is associated with independence in many activities, and impairments in upper extremity function can compound difficulties in many other areas, such as bowel and bladder management. Thus, it is not surprising that restoring hand function was found to be a priority for individuals with tetraplegia. Nowadays, magnetic resonance imaging (MRI) plays an essential role in the diagnosis of SCI and helps to monitor disease progression and efficacy of therapies. Advanced MRI techniques, such as diffusion tensor imaging (DTI) and functional MRI (fMRI), have shown the potential to improve the understanding of human spinal cord in healthy and pathological condition, and serve as imaging biomarkers to characterize damage degree, monitor the response to treatment, and predict the outcome of intervention. Meanwhile, multi-channel EMG (Electromyography) recordings can provide a mapping of neuromuscular activities from an electrode-array. The application of robotics in upper extremity function restoration of SCI patients has been started to help SCI patients to recovery upper extremity function. Combined DTI and fMRI to monitor the recovery of upper extremity function of SCI patients, this project will provide a tailored-made EMG driven soft-robotic hand prosthesis for tetraplegia individuals. We will provide the individuals with neuromuscular rehabilitation to preserve the residual function and to enhance the functional recovery. The eventual goal is to further design a useful robotic hand for regaining partial daily function to improve the quality of life for those individuals with tetraplegia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study will apply spinal cord resting-state fMRI and DTI to patients with cervical spinal cord injury. Findings with fMRI/DTI will compare to clinical hand function evaluation by using American Spinal Injury Association (ASIA) with full ASIA sensory and motor examinations (International standards for neurological classification of spinal cord injury (ISNCSCI)). After baseline spinal cord MRI scan, those patients will receive 3 months muscle strength enhancement as pre-rehabilitation. Then, we will design robotic hand rehabilitation programme for each individuals. All participants will receive robotic rehabilitation for 1 year. After then, a follow-up spinal cord MRI scan and clinical assessment will evaluate the results of this project.
Masking
Investigator
Masking Description
Patients with tetraplegia under the care of our department will be recruited. Spinal cord resting-state fMRI and DTI, surface EMG tests from different muscles from arm will be detected to define 5 most possible suitable candidates for this project.
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baseline before robotic functional rehabilitation
Arm Type
No Intervention
Arm Description
Baseline spinal cord MRI scan
Arm Title
post rehabilitation
Arm Type
Experimental
Arm Description
Those patients will receive 3 months muscle strength enhancement as pre-rehabilitation. Then, we will design robotic hand rehabilitation programme for each individuals. All participants will receive robotic rehabilitation for 1 year. After then, a follow-up spinal cord MRI scan and clinical assessment will evaluate the results of this project.
Intervention Type
Device
Intervention Name(s)
Robotic Functional Rehabilitation system
Intervention Description
The tailored-made EMG driven soft-robotic hand prosthesis for tetraplegia individuals may help to preserve the residual function and to enhance the functional recovery.
Primary Outcome Measure Information:
Title
Spinal cord neuroimage
Description
Advanced MRI techniques, such as diffusion tensor imaging (DTI) and functional MRI (fMRI)
Time Frame
Changes between baseline on enrollment and 12 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with tetraplegia under the care of Department of Orthopaedics and Traumatology, LKS Faculty of Medicine, The University of Hong Kong in Queen Mary Hospital. Exclusion Criteria: Subjects with any neurological abnormality in brain, intellectual disability or other communication difficulty, subjects with pacemaker or metal implants, subjects with claustrophobia
Facility Information:
Facility Name
The university of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

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Robotic Rehabilitation for Spinal Cord Injury

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