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Robotic Rehabilitation for Spinal Cord Injury (SCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483766
Recruitment Status : Unknown
Verified September 2019 by The University of Hong Kong.
Recruitment status was:  Active, not recruiting
First Posted : March 30, 2018
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

Study Description
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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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: Robotic Functional Rehabilitation system Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention 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: Single (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.
Primary Purpose: Health Services Research
Official Title: Individualized Robotic Functional Rehabilitation for Spinal Cord Injury
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Device: Robotic Functional Rehabilitation system
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483766


Locations
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Hong Kong
The university of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
More Information
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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03483766    
Other Study ID Numbers: UW 17-307
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System