Neural Mechanisms of Motor Recovery With Technology Assisted Training

NCT ID: NCT05560867

Last Updated: 2024-08-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-14
• Study Completion Date: 2024-05-01

Brief Summary

Stroke is a leading cause of disability that often impairs arm function and activities of daily living. The costs of rehabilitation are significant and practical constraints often limit therapy to the first few months after stroke. However many studies have shown that patients in the later stages post-stroke can still continue to benefit from rehabilitation. Technology-assisted therapy may offer a means to efficiently provide ongoing therapies to patients in the later stages (>6 months) post-stroke. This study will determine which patients are best able to benefit from this therapy approach, and will also expand our knowledge of which brain structures need to be intact for patients to benefit from technology-assisted training. The results of this study will help to improve rehabilitation and quality of life for disabled Americans.

Detailed Description

Study Description: This study will investigate the neural mechanisms of technology-assisted-training for post-stroke hemiparesis by using functional near-infrared-spectroscopy (fNIRS). Patients with hemiparesis affecting the arm will be brought in for 3 weeks of technology-assisted-training while having fNIRS recordings of their brain activity. Analysis of these brain activation patterns will help determine what areas of the brain are necessary to respond to this type of training.

Objectives: 1) to investigate brain network activity changes that occur during technology-assisted-training and 2) to determine the baseline residual brain network connectivity required for patients to respond to robot-assisted-training.

Endpoints: The study will evaluate increases in cortical connectivity between bilateral primary motor areas, angular gyrus and parietal operculum to test the hypothesis that cortical connectivity in these areas will positively correlate with improvement in technology-assisted-assessments. The study will also assess baseline connectivity of the angular gyrus and parietal operculum to sensorimotor networks to test the hypothesis that cortical connectivity in these areas will predict reductions in arm motor impairments that occur with technology-assisted-training.

Study Population: Patients of either gender with chronic (at least 6 months or more) hemiparesis of the arm caused by a single unilateral stroke will be recruited from Baltimore city and the surrounding counties.

Conditions

Hemiparesis; Stroke Sequelae

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient Robot-Assisted Training Group

Patients will undergo robot-assisted physical therapy three times a week, for a total of 9 sessions, while functional near-infrared spectroscopy data is collected.

Group Type: OTHER

robot-assisted training

Intervention Type: DEVICE

These training platforms use gamified training tasks to improve motor control in the hemiparetic arm

Interventions

robot-assisted training

These training platforms use gamified training tasks to improve motor control in the hemiparetic arm

Intervention Type: DEVICE

Other Intervention Names

IMT InMotion Wrist Robot; IMT InMotion2 Shoulder-Elbow Robot; IMT InMotion2 Planar Robot

Eligibility Criteria

Inclusion Criteria

• Age 18 to 88 years
• Able to provide informed consent based on Evaluation to Sign Informed Consent.
• History of clinically defined, unilateral hemiparetic stroke, with radiologic exclusion of other possible diagnosis, causing weakness in 1 arm 6 months or more prior to enrollment.
• Fugl-Meyer upper extremity score <= 50 at time of enrollment
• Medically stable to participate in the study and have mobility, visual, and cognitive abilities sufficient to follow directions and engage in the gamified therapeutic tasks.

Exclusion Criteria

• Undergoing any significant medical treatments requiring regular visits, treatments, or therapies at the time of enrollment or anytime during the study.
• Hair or scalp implant that would not allow near infrared spectroscopy probes to sit on scalp.
• Injection of botulinum toxin to the paretic arm within 3 months of enrollment or during the study or injection of daxibotulinumtoxinA within 6 months of enrollment or during the study
• Orthopedic, rheumatologic, or other medical disease that would make the procedures of participation dangerous, painful, or uncomfortable.
• Contraindications to MRI, including intracranial magnetic items, implanted pumps, pacemakers, or stimulators, or claustrophobia.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Robynne Braun, MD, PhD

Assistant Professor, Department of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Maryland

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

HP-00093740

Identifier Type: -

Identifier Source: org_study_id