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H2 Lower Limb Exoskeleton for Stroke Rehabilitation

This study is looking at how a robotic device called the H2 lower limb powered exoskeleton can help people recover after a stroke. The H2 is a wearable robot that assists with hip, knee, and ankle movements. Researchers will compare robot-assisted training with regular supervised motor practice (walking and other exercises with a physical therapist). The study also aims to understand how the brain learns to use the exoskeleton by looking at brain wave patterns. This research could help design smarter devices that can be controlled by thought. You may be able to join if you are between 18 and 75 years old, had a stroke at least 3 or 6 months ago, and have good cognitive ability. Success will be measured by improvements in your lower body movement, walking ability, and how your joints move when you walk. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 60 participants. It compares robot-assisted training with supervised motor practice.
What's involved
Participants will undergo robot-assisted training with the H2 exoskeleton or supervised motor practice. Assessments will be done at the start, right after the intervention, and then at 2 weeks and 2 months later.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 2 months after the intervention is completed.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02114450

Human-Machine System for the H2 Lower Limb Exoskeleton

Recruiting
NAAges 18–75InterventionalBasic science
University of Houston
~60 participants
Updated 2024-10-30 on ClinicalTrials.gov
What's tested:Robot-assisted training with the H2 lower limb powered exoskeletonSupervised motor practice

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in Fugl-Meyer Assessment - Lower Extremity Motor Function
Measured over Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months
+3 more outcomes measured

Conditions

Stroke
Hemiparesis

Explore related trials

HemiparesisStroke

NCT02114450

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • TIRR Memorial Hermann Hospital

    Houston, Texasstudy coordinator listed

    Not yet recruiting

  • University of Houston

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jose L Contreras-Vidal, PhD · PRINCIPAL_INVESTIGATOR · University of Houston
  • Gerard E Francisco, MD · PRINCIPAL_INVESTIGATOR · TIRR Memorial Hermann Hospital
  • Jose L Pons, PhD · PRINCIPAL_INVESTIGATOR · Spanish Research Council

Who to contact

Jose L Contreras-Vidal, PhD
[email protected]
713-743-4429
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Change from baseline in Fugl-Meyer Assessment - Lower Extremity Motor FunctionBaseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months

    This test evaluates and measures recovery in post-stroke hemiplegic patients, used in both clinical and research settings and is one of the most widely used quantitative measures of motor impairment. It uses an ordinal scale for scoring of 17 items for the lower limb component and 7 items on the Balance component of the F-M scale (0;con not perform; 1:can perform partially; 2:can perform fully). The total score ranges from 0 to 34, with higher scores representing better function.

  • Change from baseline in Functional Gait AssessmentBaseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months

    This scale assesses postural stability during various walking tasks using a 10-item test with each item scored from 0 to 3 (0 = severe impairment and 3 = normal ambulation). This test has high criterion validity to assess functional status in stroke patients, and has been shown to be responsive to measure change.

  • Change from baseline in Lower limb joint kinematics during walkingBaseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months

    Lower limb joint kinematics (bilateral hip, knee and ankle joints) will be assessed through surface motion sensors placed on the skin during walking. This assessment will help study and characterize subtle changes in lower limb kinematics pre- and post-intervention.

  • Change in cortical dynamics measured by Electroencephalography (EEG)Each Experimental/Training Session (12 visits) over the 4 week training period

    Time and frequency domain analysis will be performed on scalp EEG signals to characterize changes in cortical dynamics, specifically in gait initiation and sensory-motor cortical networks. Additionally, we will also evaluate the extent to which lower limb kinematics during gait can be reconstructed from scalp EEG of the user. This will be used to evaluate the neural basis of changes in lower limb joint motion as well as develop EEG-based brain-machine interfaces to robotic exoskeletons.