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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.
Spinal cord injury (SCI) is a medically complex and life-disrupting condition. Each year in the United States, it is estimated that 17,700 new traumatic SCI cases are reported, including many active service men and women, and veterans. About half of those, the injury involve some part of the arm and hand, representing significant disability and dependence for those patients and their families. When arms/hands are impaired, the patient's quality of life and level of independence are reduced. The proposed RCT investigation will evaluate the long-term effects of the UE-MPWO (MyoPro) in ameliorating wrist/hand/UE movement capability, and increasing ADL and quality of life in people with SCI. This MyoPro orthosis can assist elbow and hand function with built-in motors that are activated by patients' intended motion, as represented by the residue voluntary muscle activities detected by the device's sensors.
The impact of the data generated from this clinical trial investigation should advance the application of new orthotic and prosthetic technologies to treating disabilities as a result of injuries or diseases such as SCI and promote home and community uses of the technologies to improve daily function and independence. The study would also advance scientific knowledge regarding neural changes occurring in the nervous system by application of the technology. The learned knowledge from this investigation will further justify the utilization of such an orthotic technology for individuals with SCI.
Beyond the common therapeutic benefits of upper extremity motor function rehabilitation and assistance for daily living provided with utilization of the MyoPro orthotic device, there may be additional benefits including improvements in quality of life and activity of daily living due to recovered function by using the device. The clinical trial investigation described in this application would provide clinicians and therapists with an initial, but stronger basis for integrating such an orthosis into regimens for managing upper extremity impairments in persons with SCI. This would represent a significant improvement to the existing paradigms of treating hand/arm disabilities in persons with SCI. The benefits, for the patients and society (including the VA community), of utilizing such an orthotic device during daily activities at home and in the community far outweigh the minimal risks associated with this FDA-approved orthosis, particularly as those minimal risks have been minimized by using sound research methodologies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MyoPro | Experimental | Receiving MyoMo training in-clinic for 6 weeks, and continuing MyoMo training in-clinic and at home for another 6 weeks. |
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| Control | Active Comparator | Receiving conventional therapy in-clinic and using their prescribed static brace (or others) for 6 weeks, and continuing the conventional therapy in-clinic and home using their prescribed static brace (or others) at home for 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyoMo | Device | To 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kessler Foundation | Recruiting | West Orange | New Jersey | 07052 | United States |
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Randomized Clinical Trial
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| conventional therapy | Other | To 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. |
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| Approximately 36 weeks |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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