BridgeMD
Tests treatment safety and results for Acquired Brain Injury (Including Stroke)
Official title Clinical Investigation to Validate the Safety and Performance of Integrating Functional Electrical Stimulation Into the ABLE Exoskeleton
ClinicalTrials.gov ID: NCT07550699
What this study is testing
- What it's testing
- The primary objective of this study is to validate the safety and clinical performance of the ABLE Exoskeleton with integrated Functional Electrical Stimulation (ABLE FES) in individuals with neurological conditions that impair gait, including spinal cord injury, acquired brain injury, and multiple sclerosis. The secondary objective is to collect preliminary data on the potential clinical and psychosocial benefits of combining robotic gait assistance with electrical stimulation.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 18 to 80 years old
- Diagnosis of acquired brain injury, spinal cord injury (neurological level between C5 and L2, AIS B to AIS D), or multiple sclerosis
- Currently undergoing physiotherapy treatment, either as an inpatient or outpatient at the investigating center
- Ability to provide informed consent
You likely can't join if
- Significant osteoporosis that may increase the risk of fracture
- Unresolved fractures in the pelvis or limbs, or a history of fragility fractures in the lower limbs within the past 2 years
- Spinal instability (or use of spinal orthoses, unless medically approved)
- Deterioration \>3 points of the total in the motor score of the International Standards for the Neurological Classification of Spinal Cord Injury...
- Severe spasticity: Level 4 on the Modified Ashworth Scale
- Orthostatic hypotension: Inability to tolerate at least 10 minutes in an upright position
See the full eligibility criteria
- 18 to 80 years old
- Diagnosis of acquired brain injury, spinal cord injury (neurological level between C5 and L2, AIS B to AIS D), or multiple sclerosis
- Currently undergoing physiotherapy treatment, either as an inpatient or outpatient at the investigating center
- Ability to provide informed consent
- Significant osteoporosis that may increase the risk of fracture
- Unresolved fractures in the pelvis or limbs, or a history of fragility fractures in the lower limbs within the past 2 years
- Spinal instability (or use of spinal orthoses, unless medically approved)
- Deterioration \>3 points of the total in the motor score of the International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) in the last 4 weeks. Loss of sensation and/or motor activity...
- Severe spasticity: Level 4 on the Modified Ashworth Scale
- Orthostatic hypotension: Inability to tolerate at least 10 minutes in an upright position
- Uncontrolled autonomic dysreflexia
- Medical instability
- Unstable cardiovascular condition, hemodynamic instability, untreated hypertension (SBP \> 140 mmHg, DBP \> 90 mmHg), deep vein thrombosis (DVT), or uncontrolled autonomic dysreflexia
- Severe comorbidities, including any condition deemed inappropriate by the investigator for using the ABLE Exoskeleton or for completing the study
- Pressure ulcers Grade I or higher (as defined by the European Pressure Ulcer Advisory Panel - EPUAP) in areas that will be in contact with the device
- Anthropometric measurements incompatible with the ABLE Exoskeleton, specifically height outside the 1.5-1.9 m range or weight exceeding 100 kg
- Anatomical constraints (such as leg length differences, users unable to position themselves inside the device) that are incompatible with the device
- Range of motion restrictions preventing normal gait or sit-to-stand transitions, including: Ankle: ability to achieve at least neutral (0°) position; Knee: ability to extend to at least -10°; Hip: bilateral hip flexion...
- Heterotopic ossification
- Pregnant or breastfeeding women
- Cognitive impairment that results in the inability to follow simple instructions, particularly psychological or cognitive problems that do not allow a participant to follow study procedures
- Requires assisted ventilation.
- Scoliosis \>40-50º Cobb angle.
- Presence of pacemakers, defibrillators, or other non-compatible electronic implants.
- Open wounds, infections, or active irritation at the electrode placement sites.
- Severe dermatological conditions in the stimulation area.
- Uncontrolled active epilepsy.
- Malignant tumors in the area of application.
- Severe loss of sensation in the areas where electrodes are to be placed.
- Medical conditions where electrical stimulation is contraindicated by physician recommendation.
- Inability to communicate pain, discomfort, or adverse reactions during stimulation.
- Venous thrombosis, thrombophlebitis, or severe arterial obstruction.
- Chronic venous insufficiency with significant varicosities.
- Hemophilia.
- Ongoing infectious process or fever.
- Presence of metallic implants in the flow area between the electrodes
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, State of Vienna, Austria
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, State of Vienna, Austria. 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.