Using a robotic exoskeleton for rehabilitation after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Houston
  Houston, Texas, United States Recruiting
• TIRR Memorial Hermann Hospital
  Houston, Texas, United States Not yet recruiting

Study contacts

• Principal investigator: Jose L Contreras-Vidal, PhD — University of Houston
• Study coordinator: Jose L Contreras-Vidal, PhD
• Email: jlcontreras-vidal@UH.EDU
• Phone: 713-743-4429

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.