NCT02114450Recruiting
Human-Machine System for the H2 Lower Limb Exoskeleton
Human Machine Interface System With the H2 Lower Limb Exoskeleton for Rehabilitation
Source: ClinicalTrials.gov · Last updated 30 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This research study will investigate the use of smart lower limb robotic exoskeleton (developed by the CSIC, Spain) in rehabilitation after stroke. It will compare robotic-assisted rehabilitation with supervised motor practice. Additionally, it will also examine the use of noninvasive scalp electroencephalography (EEG) to learn specific brain wave patterns associated with learning to walk on the powered lower limb exoskeleton. The findings will be used to understand human-robot interaction and to design smart orthotic devices that can be controlled by thought activity and assist those that have lost all or part of their walking abilities.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 8 Apr 2014
- Start date
- 20 Nov 2015
- Primary completion date
- Dec 2027
- Lead sponsor
- University of Houston
- Diseases
- Stroke
- NCT number
- NCT02114450
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 20 Nov 2015 to the primary completion date, Dec 2027
- 2 sites 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
- Uncontrolled angina;
- Severe chronic obstructive pulmonary disease;
- \- History of neurological, neuromuscular or physical disability.
Other
- Severe cognitive and/or visual deficit;
- Hemineglect (determined based on medical record or initial clinical assessment);
- Severe sensory deficit;
- Joint contractures of any extremity that limits normal range of motion during ambulation with assistive devices;
- Skin lesions that may hinder or prevent the application of exoskeleton;
- Other medical contraindications; any medical co-morbidities that would prevent standard rehabilitation.
Who the study is looking for
- Sub-acute or chronic stroke i.e., interval of at least 3 months or interval of at least 6 months from stroke to time of enrollment, respectively;
- Cognitive ability to assimilate and participate actively in the treatment protocol (Mini Mental State Examination score \> 24 points, out of a total 30 indicating normal cognitive ability);
- Modified Rankin scale scores 2-4 (Mild-Moderate functional disability post-stroke);
- Modified Ashworth Scale of Spasticity score \<= 2 (ranges from 0-4 with 4 reflecting maximum spasticity);
- Have no skin integrity issues;
- Sufficient passive range of motion at the hip (at least 90 deg flexion, 15-20 deg extension), knee (90 deg flexion, complete extension) and ankle (15 deg dorsiflexion, 15 deg plantarflexion);
- Have no contraindications to standing or walking; able to stand with assistive device for at least 5 minutes, and able to walk with assistive device for 10 m.
- Able to understand and sign the consent form
- Age 18-75 years
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Houston Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| TIRR Memorial Hermann Hospital Coordinator of this site? Confirm its status | Houston | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.