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New treatment option 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 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.
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;
- Other medical contraindications; any medical co-morbidities that would prevent standard rehabilitation. Inclusion criteria for healthy, able-bodied participants:
- 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's taking place
- 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 - 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?
Study sites include Houston, Texas, United States. 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.