NCT04251091Active, not recruiting
Ankle Exosuit Training in the Clinic to Community Community
Ankle Exosuit Training in the Clinic to Community
Source: ClinicalTrials.gov · Last updated 1 Apr 2025
Brief summary (registry, in English)
This study focuses on investigating exosuit technology by evaluating its ability to provide a gait-restorative effect delivered in both clinic and community settings. The exosuit provides dynamic dorsiflexion and plantarflexion assist during walking. We will determine the effect of training parameters of intensity, repetition, and gait quality which are all key parameters associated with experience-dependent neuroplasticity. The other objective is to determine the effect of this intervention on community walking activity, walking speed, walking distance, and locomotor mechanics and energetics.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 29 Jan 2020
- Start date
- 10 Jan 2020
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Arun Jayaraman, PT, PhD
- Diseases
- Stroke
- NCT number
- NCT04251091
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 10 Jan 2020 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Score of \>1 on question 1b and \>0 on question 1c on the NIH Stroke Scale
- History of significant Peripheral Artery Disease (PAD)
- Unresolved Deep Vein Thrombosis (DVT)
- Uncontrolled or untreated hypertension
- Psychiatric or cognitive impairments that may interfere with proper operation of the device
Other
- Inability to communicate with investigators
- Neglect or hemianopia
- Unexplained dizziness in the last 6 months
- Pressure ulcers or skin wounds located at human-device interface sites
- Significant paretic ankle contractures (plantarflexion \> 5°)
Who the study is looking for
- Age 18 - 80 years old
- Stroke event occurred at least 6 months ago
- Observable gait deficits
- Able to walk without the support of another person for at least 2 minutes (with or without an assistive device or orthotic support)
- Passive ankle dorsiflexion range of motion to neutral with the knee extended (i.e., able to achieve an angle of 90 degrees between the shank and the foot)
- Resting heart rate between 40 - 100 bpm, inclusive
- Resting blood pressure between 90/60 and 170/90 mmHg, inclusive
- Medical clearance by a physician
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shirley Ryan AbilityLab Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.