Upper Extremity Dysfunction Clinical Trial
Official title:
The Utilization Effects of Powered Wearable Orthotics in Improving Upper Extremity Function and ADL in Persons With SCI
Verified date | April 2024 |
Source | Kessler Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the usefulness of an upper extremity assistive device, called (MyoPro) in improving upper extremity activities in people with incomplete spinal cord injury. The Department of Defense is supporting this study.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | October 1, 2028 |
Est. primary completion date | October 1, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Be between ages 18-80 - Be able to activate certain muscles in my arm and forearm on my own a sufficient amount as measured by EMG amplitude. This will be determined by the study OT/PT. - Be diagnosed with spinal cord injury (SCI) with level C1-C8 and ASIA Impairment Scale (AIS) C or D, as determined by study staff. If I have not had an exam to determine my injury level and impairment scale recently, I may participate in an examination of my sensation and strength in my arms, legs, trunk and rectum as was done in the hospital soon after my injury. - Be at least 1-year post injury - Have sufficient ability to move my shoulder (active shoulder flexion of 30 degrees and active shoulder abduction 20 degrees), as determined by study staff - Be medically stable - Have sufficient learning and memory abilities and abilities to communicate in English to be able to participate and follow directions during my rehabilitation - Continue to take all prescribed medication (e.g., oral or via pump baclofen) without any dosing changes - Be able to tolerate functional tasks for 60 minutes with periodic rests without excessive fatigue - Have minimal strength in the muscles that bend and straighten my elbow, as determined by study staff - Have full range of motion in my elbow when it is moved by the study therapist Exclusion Criteria: - Be younger than 18 years old or older than 80 - Have excessive pain in my arm, wrist, or hand that limits providing rehabilitation - Have excessive spasticity in my elbow or wrist, as determined by study staff - Be participating in any experimental rehabilitation or drug studies - Have history of nervous system disorder other than SCI - Have difficulty following multiple step directions - Have severe cognitive or psychiatric problems might be contraindications to start training. - Have skin issues or severe sensory deficits that would prevent wearing the Myo-Pro device safely - Be pregnant - Have other conditions or circumstances that, in the opinion of the investigators, would affect the safety or effectiveness of the training in which I would participate |
Country | Name | City | State |
---|---|---|---|
United States | Kessler Foundation | West Orange | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Kessler Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | GRASSP | Assessment of the Hand in Tetraplegia Using the Graded Redefined Assessment of Strength Sensibility and Prehension Upper Extremity (UE) Function in Persons with Tetraplegia Relationships Between Strength, Capacity and the Spinal Cord Independence Measure.
Total score's minimum and maximum values are between 0 to 116 and higher scores indicate better/improved outcomes. |
Approximately 36 weeks | |
Primary | Range of motion of hands and arms | Movement of upper extremity is measured using small sensors that are able to record joints' angles. These sensors are placed on participant's skin via double sticky tape.
Participants will be asked to move their hand and forearm while the elbow, wrist and hand joint angles are measured. |
Approximately 36 weeks | |
Primary | Muscle strength measurement | during movements of upper extremities muscle strength is measured using small and light weight surface electromyography sensors which are placed on the participant's skin via double stick tape.
Participants will be asked to move their hand and forearm while the muscle strength is measured. |
Approximately 36 weeks | |
Secondary | Spasticity measurement | Spasticity measurements of upper and lower extremities using the Modified Ashworth scale (MAS).
The MAS scores range between 0 to 4. A higher score signifies larger level of spasticity and a lower score indicates smaller level of spasticity. scores are as follows: 0: No increase in muscle tone Slight increase in muscle tone 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion More marked increase in muscle tone through most of the range of motion. Considerable increase in muscle tone, passive movement difficult Affected part(s) rigid in flexion or extension |
Approximately 36 weeks | |
Secondary | Brain signals measurement | Measurements of brain signals is done using a cap and electrodes that would be placed on the participant's head using surface electrodes.
Participants will be asked to move their extremities while brain signals are measured. |
Approximately 36 weeks | |
Secondary | CUE-Q | The Capabilities of Upper Extremity Test (a list of questionnaire based evaluation).
Scores range between 0 to 4, and higher scores indicates better ability outcome for reaching or lifting the upper limb. |
Approximately 36 weeks |
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