Recruiting

Robot-Assisted Rehabilitation

Sponsor:

University of Houston

Code:

NCT05374486

Conditions

Stroke

Hemiparesis

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Not accepted

Interventions

NeuroExo co-robot neurorehabilitation system

Study Details

Brief summary:

The goal of this study is to develop a clinically feasible, low-cost, nonsurgical neurorobotic system for restoring function to motor-impaired stroke survivors that can be used at the clinic or at home. Moreover, another goal is to understand how physical rehabilitation assisted by robotic device combined with electroencephalograph (EEG) can benefit adults who have had stroke to improve functions of their weaker arm.

The proposed smart co-robot training system (NeuroExo) is based on a physical upper-limb robotic exoskeleton commanded by a non-invasive brain machine interface (BMI) based on scalp EEG to actively include the participant in the control loop .

The study will demonstrate that the Neuroexo smart co-robot arm training system is feasible and effective in improving arm motor functions in the stroke population for their use at home.The NeuroExo study holds the promise to be cost-effective patient-centered neurorehabilitation system for improving arm functions after stroke.

Conditions

Stroke

Hemiparesis

Study ID

NCT05374486

Start date

Apr 25, 2022

Status verified date

May, 2022

Completion date

Aug, 2022

Anticipated

Primary completion date

Aug, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • subjects between the ages of 20-65, male or female,
  • mild-to- moderate unilateral stroke confirmed by brain CT or MRI scan and manifested by a Glasgow Coma scale (GCS) score between 15 and 9 documented within 6 months,
  • the ability to perform 20deg of active wrist/elbow for upper limb robotic movement on the affected side, no planned alteration in lower/upper- extremity therapy/medication for muscle tone during course of study,
  • Anticipated length of needed acute interdisciplinary rehabilitation of 30 days or more.
  • Patients are required to have a MMSE>=24 to rule out those with cognitive impairments.
  • Patients will have to have normal/near normal strength in one upper/lower extremity and appreciable weakness in the other upper/lower extremity.

Exclusion Criteria:

  • history of traumatic brain injury prior to the current episode,
  • Severe neurologic or psychiatric condition preventing participation in rehabilitation and physical therapy activities (patients unable or unwilling to receive instruction and effectively complete a simple assigned task as determined by MMSE>=24 specified in inclusion criteria).
  • Women and minorities will be recruited as long as they meet the inclusion criteria.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NeuroExo

NeuroExo is a device which includes a robotic exoskeleton that you were in your affected arm to assist you with arm movements, a headset that you wear on your head to measure your brain activity and detect your intention to move, and a graphical user interface that allows you to initiate and stop neurotherapy, and track your motor performance.

Interventions

NeuroExo co-robot neurorehabilitation system

In this longitudinal study, adult subjects with hemiparesis due to chronic stroke will receive robotic-assisted upper-arm training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG). After one screening visit, two baseline visits for EEG signal screens, six onsite training sessions will be provided with the NeuroExo system, followed by 60 home therapy sessions (2 sessions per day, 5 days per week for 6 weeks). If the participant have completed at least 50 sessions of neurotherapy at home, the participant will complete a set of measurements to assess function of the affected upper arm and brain activity within 3 days after the last session for post-assessment visit, and one-month post follow-up session. The total amount of time for this study is 16-20 weeks.

Primary outcome measure

  • Change From Baseline in Fugl-Meyer Arm (FMA) Motor Score [ Time Frame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment ]
  • Neural Activity (Cortical Dynamics) Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Amplitude [ Time Frame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment ]
  • Cortical Dynamics Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Latency [ Time Frame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment ]
  • Movement Quality as Assessed by Exoskeleton Kinematics [ Time Frame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment ]
  • Movement Quality as Assessed by Exoskeleton Kinematics - Number of Peaks [ Time Frame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment ]
  • Movement Quality as Assessed by Exoskeleton Kinematics - Time to First Peak [ Time Frame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment ]

Central Contacts and Locations

Central contacts

Study Coordinator

713 799 7016shuo-hsiu.chang@uth.tmc.edu

Locations

TIRR Memorial Hermann Hospital

Recruiting

Houston, Texas, United States, 77056

Contacts

Gerard E Francisco, MD

713-797-5244gerard.e.francisco@uth.tmc.edu

Shuo-Hsiu Chang, PT, PhD

713-799-7016Shuo-Hsiu.Chang@uth.tmc.edu

Principal Investigator:

Gerard E Francisco, MD

University of Houston

Recruiting

Houston, Texas, United States, 77204

Contacts

Jose L Contreras-Vidal, PhD

713-743-4429jlcontreras-vidal@uh.edu

Principal Investigator:

Jose L Contreras-Vidal, PhD

More Information

Sponsor

University of Houston

Last update posted

May 16, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Houston on 2022-05-16.