Kessler Foundation
West Orange, New Jersey, 07052, United States
Location status: Recruiting
NCT Number: NCT04921592
This study is to understand how the combination of activity-based recovery training and targeted spinal cord transcutaneous stimulation (scTS) can improve participants' ability to use their hand, arms, and core.
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Request Info18 year and older
All sexes
Interventional
Not applicable
West Orange, New Jersey, 07052, United States
Location status: Recruiting
This study is to understand how the combination of activity-based recovery training and targeted spinal cord transcutaneous stimulation (scTS) can improve participants' ability to use their hand, arms, and core. Activity-based recovery training aims to advance independence without the use of assistive devices. Spinal cord transcutaneous stimulation is an electrical stimulation that is provided on top of the skin over specific areas of the spinal cord to activate the circuitry for the activity that is being trained and reconnect with pathways between the brain and spinal cord.
i) Physical evaluation by the clinician or physician including the Classification of Spinal Cord Injury (ISNCSCI exam. ii) A series of tests to evaluate the trunk, arm function with and without using tests to evaluate muscle activation. iii) A series of questionnaires to evaluate function and quality of life iv) Two separate Magnetic Resonance Imaging (MRI) of spinal column (head to hip).
Randomized to one of three groups:
Group 1: will be upper extremity training with transcutaneous spinal stimulation of the spine combined with upper extremity and trunk rehabilitation. The group will complete 60 training sessions transcutaneous spinal stimulation.
Group 2: will be upper extremity training with transcutaneous spinal stimulation of the spine combined with upper extremity and trunk rehabilitation. The group will complete 40 training sessions of transcutaneous spinal stimulation. The group will then complete 20 sessions of rehabilitation therapy of the upper extremities and trunk (no stimulation).
Group 3: will be will be upper extremity training with transcutaneous spinal stimulation of the spine combined with upper extremity and trunk rehabilitation. The group will complete 20 training sessions of transcutaneous spinal stimulation. The group will then complete 40 sessions of rehabilitation therapy of the upper extremities and trunk (no stimulation).
Transcutaneous spinal stimulation will involve stimulating the spinal segments between C5/6 to lumber regions. Training time will be approximately 1 hour, 3-4 times per week.
Rehabilitation therapy will involve exercises concentrating on fingers, hand, arm and trunk function. A physical therapist will be at training and testing sessions.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
transcutaneous stimulation of the upper extremities
Other names: Activity-Based Recovery Therapy (ABRT)
Time frame: 6 months
Measure of the degree a person who has sustained a spinal cord injury (SCI) has recovered the ability to perform functional tasks relative to how the individual performed these tasks prior to injury. The NRS consists of a numeric version of the visual analog scale. The most common form of the NRS is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. This type of scale can be administered verbally.
Contact information is provided by the study sponsor or research team.
Kessler Foundation
Other
Neuromodulation Training for Upper Extremity Recovery for Chronic Cervical Spinal Cord Injury
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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