Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury (NCT04340063) | Clinical Trial Compass
CompletedNot Applicable
Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury
United States38 participantsStarted 2020-10-15
Plain-language summary
Spinal cord injury (SCI) affects \~42,000 Veterans. The VA provides the single largest network of SCI care in the nation. The lifetime financial burden of SCI can exceed $3 million. A major cost of SCI is impaired mobility. Limited mobility contributes to decreased ability to work, increased care requirements, secondary injury, depression, bone mineral density loss, diabetes, and decreased cardiovascular health. Among ambulatory individuals with iSCI, residual balance deficits are common and are strongly correlated with both functional walking ability and participation in walking activities. The development of effective rehabilitation tools to improve dynamic balance would substantially improve quality of life for Veterans living with iSCI. Improving mobility through interventions that enhance dynamic balance would positively impact health, independence, and the ability to integrate into social, intellectual, and occupational environments.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Medically stable with medical clearance from a physician to participate
* Neurologic level of the SCI between C1-T10 with American Spinal Injury Association (ASIA) Impairment Scale (AIS) C or D
* \> 6 months since initial injury
* Passive range of motion of the legs within functional limits and not restricting the ability to engage in locomotor training
* Able to ambulatory 10m with no physical assistance, use of assistive devices (e.g. single cane, rolling walker), and/or braces that do not cross the knee joint (e.g. ankle foot orthosis) are permitted
* Able to provide transportation to and from the testing location.
Exclusion Criteria:
* Excessive spasticity in the lower limbs as measured by a score of \> 3 on the Modified Ashworth Scale
* Inability to tolerate 30 minutes of standing
* Severe cardiovascular and pulmonary disease
* History of recurrent fractures or known orthopedic problems in the lower extremities (i.e. heterotopic ossification)
* Concomitant central or peripheral neurological injury (i.e. traumatic head injury or peripheral nerve damage in lower limbs)
* Inability to provide informed consent due to cognitive impairments
* Presence of unhealed decubiti or other skin compromise
* Enrollment in concurrent physical therapy or research involving locomotor training
* Use of braces/orthotics crossing the knee joint
* Known pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Functional Gait Assessment (FGA)
Timeframe: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
2
Lateral Center of Mass Excursion
Timeframe: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
3
Daily Stepping
Timeframe: Pre-training assessment (Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)