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New treatment option for Spinal Cord Injuries (SCI)
Official title Self-balancing Personal Exoskeleton for SCI (Site 2)
ClinicalTrials.gov ID: NCT06814015
What this study is testing
- What it's testing
- This study aims to demonstrate the safety and effectiveness of the personal exoskeleton in individuals with spinal cord injury (SCI).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- SCI user
- Any gender, age 18 years or older;
- Motor complete or incomplete SCI with lesions at or above T6;
- ≥ 6 months post SCI;
- Able and willing to attend 9 to 10 visits1 to the center, including sessions of training and assessments of one-to-three hours duration;
You likely can't join if
- Diagnosis of neurological injury other than SCI;
- Progressive condition that would be expected to result in changing neurological status;
- Severe concurrent medical disease, illness or condition judged to be contraindicated by the site physician;
- Unhealed or unstable traumatic or high impact lower extremity fracture of any duration that is, in the clinical judgement of the study physician...
- Knee (proximal tibia and/or distal femur) BMD \<0.60 gm/cm2;
- Total hip BMD T-scores \< -3.5;
See the full eligibility criteria
- SCI user
- Any gender, age 18 years or older;
- Motor complete or incomplete SCI with lesions at or above T6;
- ≥ 6 months post SCI;
- Able and willing to attend 9 to 10 visits1 to the center, including sessions of training and assessments of one-to-three hours duration;
- Able to read, understand, and provide informed consent;
- Living in the US and speaks English. SCI user
- Diagnosis of neurological injury other than SCI;
- Progressive condition that would be expected to result in changing neurological status;
- Severe concurrent medical disease, illness or condition judged to be contraindicated by the site physician;
- Unhealed or unstable traumatic or high impact lower extremity fracture of any duration that is, in the clinical judgement of the study physician, exclusionary for standing and walking;
- Knee (proximal tibia and/or distal femur) BMD \<0.60 gm/cm2;
- Total hip BMD T-scores \< -3.5;
- Fragility, minimal trauma, or low impact fracture of the lower extremity since SCI;
- Untreatable severe spasticity judged to be contraindicated by the site physician;
- Untreated/uncontrolled hypertension, as judged to be contraindicated by the site physician;
- Unresolved orthostatic hypotension (change from baseline seated BP to a fall in 20mmHg SBP and/or fall in 10mmHG DBP and symptoms when standing), or as judged to be contraindicated by the site physician;
- Open or unhealed skin pressure sores, abrasions, or bruises at any of the contact points of the exoskeleton;
- Morphological contraindications to the use of the device;
- Uncorrectable leg length discrepancy over 2 cm (about 0.79 in) when using additional correction tools;
- Unable to effectively operate the device with a hand-control interface, due to functional and/or cognitive impairment, evaluated based on the ability to manipulate the joystick in all direction, press and identify...
- Improper fitting in the device;
- Psychopathology documentation in the medical record that may conflict with study objectives;
- Pregnancy or women who plan to become pregnant during the study period;
- Concurrent participation in another treatment trial;
- History of uncontrolled autonomic dysreflexia;
- Presence colostomy and/or urostomy;
- Ventilator use at the time of the exoskeleton use;
- Insufficient strength and performance capability (the ability to transfer into/out of the device or perform other training tasks with assistance). Companion inclusion Criteria:
- Any gender, age 18 years or older;
- Willingness to attend 9 to 10 visits to the center, including sessions of training and assessments of one-to-three hours duration with the SCI user;
- Able to read, understand and provide informed consent;
- Living in the US and speaks English. Companion exclusion Criteria:
- Inability to communicate with an assistant due to cognitive and language disorders;
- Any disease, concomitant injury, or condition that interferes with the performance or interpretation of the protocol- specified assessments;
- Insufficient strength and performance capability, evidenced by the ability to hold and retain the device in case of unbalance/fall;
- Insufficient availability to complete the study;
- Concurrent participation in another treatment trial.
The study team makes the final eligibility decision.
Where it's taking place
- West Orange, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Orange, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.