Robotic Rehabilitation for Spinal Cord Injury

NCT03483766 | Completed

• 1 other identifier: UW 17-307
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• Spinal cord neuroimage

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

  Changes between baseline on enrollment and 12 months follow-up

Study Arms (2)

Baseline before robotic functional rehabilitation

NO INTERVENTION

Baseline spinal cord MRI scan

post rehabilitation

EXPERIMENTAL

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

Interventions

Robotic Functional Rehabilitation system DEVICE

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.

post rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The university of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 30, 2018
• Study Start: September 1, 2017
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: May 11, 2023

Record last verified: 2019-09

Locations

HK (1)