Neural Mechanisms of Motor Recovery With Technology Assisted Training

NCT05560867 | Terminated DMC FDA Device

• 1 other identifier: HP-00093740
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiparesis; Stroke Sequelae

Keywords

stroke; robot-assisted rehabilitation; neural networks; fnirs; rehabilitation

Outcome Measures

Primary Outcomes (2)

• Changes in cortical connectivity measures as assessed using MRI

  Cortical connectivity is assessed between bilateral primary motor areas, angular gyrus and parietal operculum. MRI sequences include T1 MPRAGE, BOLD (T2\*), FLAIR T2, ASL, and DTI.

  Baseline MRI will be collected at the time of study enrollment (for a total of up to 4 weeks during study enrollment)

• Changes in cortical connectivity measures as assessed using fNIRS

  Cortical connectivity is assessed between bilateral primary motor areas, angular gyrus and parietal operculum.

  Baseline fNIRS collected at the time of study enrollment, with repeated fNIRS measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)

Secondary Outcomes (9)

• Changes in arm kinematics (position)

  Baseline kinematics at the time of study enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)

• Changes in arm kinematics (velocity)

  Baseline kinematics at the time of study enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)

• Changes in arm kinematics (acceleration)

  Baseline kinematics at the time of study enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)

• Changes in Fugl-Myer Scores for the Upper Extremity ("FM-UE")

  At the time of enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)

• Changes in Action Research Arm Test

  At the time of enrollment (pre-training) with a second measure at the final study session (post-training) (for a total of up to 4 weeks during study enrollment).

Study Arms (1)

Patient Robot-Assisted Training Group

OTHER

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.

Device: robot-assisted training

Interventions

robot-assisted training DEVICE

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

Also known as: IMT InMotion Wrist Robot, IMT InMotion2 Shoulder-Elbow Robot, IMT InMotion2 Planar Robot

Patient Robot-Assisted Training Group

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 88 years
• Able to provide informed consent based on Evaluation to Sign Informed Consent.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Paresis; Stroke

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Neurology

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: September 29, 2022
• Study Start: December 14, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)