Clinical trial for Stroke
Official title Human-Machine System for the H2 Lower Limb Exoskeleton
ClinicalTrials.gov ID: NCT02114450
What this study is testing
- What it's testing
- This study is testing whether a smart robotic exoskeleton can improve walking after a stroke.
- Who it's for
- You may be able to join if you had a stroke and have weakness on one side of your body.
- What's involved
- You would wear a robot suit on your legs while doing guided walking practice. You may also wear a cap that reads your brain waves during the sessions.
- Time commitment
- The study lasts several weeks with regular visits for the robot sessions and brain‑wave checks.
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 75. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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;
You likely can't join if
- 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;
- Uncontrolled angina;
See the full eligibility criteria
- 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.
- 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;
- Uncontrolled angina;
- Severe chronic obstructive pulmonary disease;
- Able to understand and sign the consent form
- Age 18-75 years Exclusion criteria for healthy, able-bodied participants: \- History of neurological, neuromuscular or physical disability.
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
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, but 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 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.