Using a robotic exoskeleton for rehabilitation after stroke

Human Machine Interface System With the H2 Lower Limb Exoskeleton for Rehabilitation

This study tests whether using a robotic exoskeleton can help stroke patients recover their walking abilities better than regular therapy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University of Houston (other)
• Locations: 2 sites (Houston, Texas and 1 other locations)
• Trial ID: NCT02114450 on ClinicalTrials.gov

What this trial studies

This research investigates the effectiveness of a smart lower limb robotic exoskeleton in rehabilitation for stroke patients. It compares robotic-assisted rehabilitation with traditional supervised motor practice to assess functional recovery. Additionally, the study explores brain wave patterns through noninvasive scalp electroencephalography (EEG) to understand the interaction between human cognition and robotic assistance. The findings aim to enhance the design of smart orthotic devices that can be controlled by thought, aiding those with impaired walking abilities.

Who should consider this trial

Good fit: Ideal candidates are individuals who have experienced a sub-acute or chronic stroke and have mild to moderate functional disabilities.

Not a fit: Patients with severe cognitive or visual impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve rehabilitation outcomes and independence for stroke survivors with gait impairments.

How similar studies have performed: While robotic-assisted rehabilitation is a growing field, systematic investigations of the specific H2 exoskeleton's therapeutic benefits are limited, making this study a novel exploration.

Eligibility criteria

Inclusion 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.

Exclusion Criteria:

* 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.

Where this trial is running

Houston, Texas and 1 other locations

• TIRR Memorial Hermann Hospital — Houston, Texas, United States (NOT_YET_RECRUITING)
• University of Houston — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Jose L Contreras-Vidal, PhD — University of Houston
• Study coordinator: Jose L Contreras-Vidal, PhD

Conditions: Stroke, Hemiparesis, Paresis, Gait rehabilitation, Human-Machine Interaction, Wearable Robotic Devices