The Utilization Effects of Powered Wearable Orthotics in Improving Upper Extremity Function and ADL in Persons With SCI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKessler Foundation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
MyoMo
DeviceTo evaluate the usefulness of extended utilization of an upper extremity assistive device, called (MyoPro) in improving upper extremity (UE) activities in people with spinal cord injury (SCI).
conventional therapy
Other interventionTo evaluate the usefulness of extended conventional therapy compared to the utilization of an upper extremity assistive device called (MyoPro) in improving upper extremity (UE) activities in people with spinal cord injury.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: MyoProExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Approximately 36 weeks2
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.
Time frame
Approximately 36 weeks3
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.
Time frame
Approximately 36 weeksSecondary outcomes
1
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
Time frame
Approximately 36 weeks2
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.
Time frame
Approximately 36 weeks3
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.
Time frame
Approximately 36 weeksSponsors and contacts
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Source ClinicalTrials.gov