BridgeMD
New treatment option for Cerebrovascular Stroke
Official title ENMS With Balance Feedback for Post-stroke Ankle-foot Rehabilitation
ClinicalTrials.gov ID: NCT04934787
What this study is testing
- What it's testing
- In this work, a novel hybrid ankle-foot robot is designed for gait rehabilitation after stroke, i.e., exoneuromusculoskeleton with balance sensing feedback (ENMS-BSF) by integrating the advantages of soft pneumatic muscle, functional electrical stimulation, exoskeleton and foot balance feedback in one system. With the assistance of the ENMS-BSF the foot drop and foot inversion could be corrected with improved muscle coordination in the paretic lower limb.
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 70
You may be able to join if
- At least 6 months after the onset of stroke
- Have sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment (Mini-Mental State...
- Have mild-to-moderate motor impairment in the affected lower limb with foot drop but be capable of standing and walking without manual assistance.
- Fugl-Meyer Assessment (FMA), total score on the lower limb \<20
- Functional Ambulatory Category (FAC) ≥4
You likely can't join if
- The exclusion criteria will be server spasticity at the ankle joint measured by Modified Ashworth Score (MAS) \>3.
- Receiving other lower limb rehabilitative interventions at the same time
See the full eligibility criteria
- At least 6 months after the onset of stroke
- Have sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment (Mini-Mental State Examination (MMSE) score \>21).
- Have mild-to-moderate motor impairment in the affected lower limb with foot drop but be capable of standing and walking without manual assistance.
- Fugl-Meyer Assessment (FMA), total score on the lower limb \<20
- Functional Ambulatory Category (FAC) ≥4
- Berg Balance Scale (BBS) ≥40
- The exclusion criteria will be server spasticity at the ankle joint measured by Modified Ashworth Score (MAS) \>3.
- Receiving other lower limb rehabilitative interventions at the same time
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, China
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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, China. 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.