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New treatment option for Spinal Cord Injuries
Official title Self-balancing Personal Exoskeleton for SCI (WIP)
ClinicalTrials.gov ID: NCT07536386
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).
- Time commitment: about 2 months
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
You may be able to join if
- User
- Any gender, age 18 years or older
- Motor complete or incomplete SCI at any level
- ≥ 6 months post SCI
- Able and willing to attend 9 visits 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...
- Individual with history of osteoporotic fracture and / or pathology or treatment causing secondary osteoporosis.
- Untreatable severe spasticity judged to be contraindicated by the site physician;
See the full eligibility criteria
- User
- Any gender, age 18 years or older
- Motor complete or incomplete SCI at any level
- ≥ 6 months post SCI
- Able and willing to attend 9 visits to the center, including sessions of training and assessments of one-to-three hours duration
- Able to read, understand, and provide informed consent.
- Patients affiliated to a social security system. 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;
- Individual with history of osteoporotic fracture and / or pathology or treatment causing secondary osteoporosis.
- 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 controller, due to functional and/or cognitive impairment, evaluated based on the ability to manipulate the joystick in all direction, press and identify buttons on the...
- 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;
- Uncontrolled autonomic dysreflexia;
- Ventilator use at the time of the exoskeleton use.
- Patient under legal protection. 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. Companion exclusion criteria:
- Inability to communicate 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
- Paris, France
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 study runs about 2 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. 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.