- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03483766
Robotic Rehabilitation for Spinal Cord Injury (SCI)
Individualized Robotic Functional Rehabilitation for Spinal Cord Injury
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- The University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Baseline before robotic functional rehabilitation
Baseline spinal cord MRI scan
|
|
|
Experimental: post rehabilitation
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spinal cord neuroimage
Time Frame: Changes between baseline on enrollment and 12 months follow-up
|
Advanced MRI techniques, such as diffusion tensor imaging (DTI) and functional MRI (fMRI)
|
Changes between baseline on enrollment and 12 months follow-up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW 17-307
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.