Spinal Cord Injuries Clinical Trial
Official title:
Influence of Wearable Intensive Nerve Stimulation on Spasticity and Function in Persons With Spinal Cord Injury
NCT number | NCT04130295 |
Other study ID # | 787 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 15, 2019 |
Est. completion date | March 25, 2021 |
Verified date | March 2021 |
Source | Shepherd Center, Atlanta GA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Spasticity is muscle spasms, bouncing (clonus) or stiffness that can negatively impact the quality of life of people with spinal cord injury (SCI). In people with spinal cord injury, spasticity can limit muscle control of the arms and hands and cause pain, discomfort, and frustration. Transcutaneous electrical stimulation has been shown to reduce spasticity after SCI. However, this type of stimulation's effects during prolonged, at-home use has not been well studied. Additionally, traditional stimulation techniques are often only available in the clinic. Therefore, this study aims to identify if wearable intensive nerve stimulation decreases spasticity in the legs of people with SCI, and if this intervention is usable and desirable to individuals with SCI.
Status | Completed |
Enrollment | 12 |
Est. completion date | March 25, 2021 |
Est. primary completion date | March 25, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Be 18-65 years of age - Have sustained cervical or thoracic SCI at least 6 months prior to initiating participation in study - Any ISNCSCI severity classification (A, B, C, or D) - Have self-reported spasticity and at the time of screening demonstrate an FSE angle of = 75 degrees on the pendulum test or = 4 beats of clonus on the drop test - May participate if utilizing oral prescription medications for control of spasticity - Ability and willingness to consent and authorize use of personal health information Exclusion Criteria: - Severe contractures of the leg/foot to be stimulated (decided during pre-assessment) that limit passive movement of the hip, knee, or ankle more than 50% of normal range of motion or presence of other orthopedic pathology that would adversely influence participation in the protocol - Any implanted catheter such as but not limited to CSF shunt, baclofen pump, or the presence of a pacemaker, implanted automatic internal cardioverter defibrillator (AICD, other cardiac implants and or conditions) - Severe pain or hypersensitivity of the leg to be stimulated (decided during pre-assessment) - Uncontrolled edema of the leg to be stimulated (decided during pre-assessment) - Current pregnancy - Lumbar spinal cord injury level - Inability or unwillingness to consent and authorize use of personal health information |
Country | Name | City | State |
---|---|---|---|
United States | Shepherd Center | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Shepherd Center, Atlanta GA | Emory University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Spasticity | Instrumented Pendulum Test: Participants will be in a semi-reclined position on a therapy mat. The examiner will then bring the participants knee into full extension before dropping the foot. The examiner will observe the number of oscillations to determine muscle stretch-induced activity | Week 1, Week 2, Week 3, and Week 7 | |
Primary | Satisfaction and Adherence Questionnaire | Participant will answer questions about how likely they would be to continue to use the intervention at home. | Week 7 | |
Primary | Spinal Cord Injury - Spasticity Evaluation Tool | a Questionnaire used to characterize the impact of spasticity on a participant's ability to perform everyday occupations. | Twice per week | |
Secondary | Manual Ankle Clonus Test | Participants are positioned in supine with legs extended. The examine will move each foot individually into dorsiflexion and observe the number of beats of clonus. This will be used to determine muscle-stretch induced activity of the lower limb | Week 1, Week 2, Week 3, and Week 7 | |
Secondary | Ankle Drop Test | Participants are seated on the edge of the table with one leg fully extended. The examiner holds the test leg 10 cm above a wooden block before dropping it onot the block to observe the duration of clonus if there is any. The test will determine muscle-stretch induced activity. | Week 1, Week 2, Week 3, and Week 7 | |
Secondary | Flexor Spasms | Participants are in supine with the hip and knee extended. The examiner will then stimulate the foot with a safety pin and observe movement of the great toe, ankle dorsiflexion, and hip and knee flexion. This tool is used to determine spasticity | Week 1, Week 2, Week 3, and Week 7 | |
Secondary | Instrumented Flexor Reflex Response | Participants will be positioned in supine with knee and hip extended. The examiner will stimulate the foot with an electrical stimulus and observe movement of the great toe, ankle dorsiflexion, and hip and knee flexion. The tool is used to determine spasticity in the lower limb. | Week 1, Week 2, Week 3, and Week 7 | |
Secondary | Global Impression of Change Scale | a self-report measure designed to quantify the participant's improvement or deterioration over time. This tool will be used to rate how spasticity is impacting the participant's function. The scale is an 11 point scale from -5, representing that spasticity is much worse, to 5, which reports that spasticity is much better. Participants will use this scale to evaluate spasticity at the ankle, hip, and knee. | Week 1, Week 2, Week 3, and Week 7 | |
Secondary | Adherence Data | Adherence data will be collected from the device, which stores data on duration and number of therapy sessions completed each day. This tool will be used to measure participant adherence. | Week 3, Week 4, Week 5, and Week 7 | |
Secondary | Assessing neurophysiological aspects of spasticity | Electrodes will be placed on the quadriceps, hamstring, tibialis anterior, and soleus muscles to observe muscle activity during rest and testing. Biomechanical measurements of lower extremity movement will be made using inertial motion capture equipment (Xsens) | Week 1, Week 2, Week 3, and Week 7 |
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