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Neural Mechanisms of Motor Recovery With Technology Assisted Training

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ClinicalTrials.gov Identifier: NCT05560867
Recruitment Status : Not yet recruiting
First Posted : September 29, 2022
Last Update Posted : October 26, 2022
Sponsor:
Information provided by (Responsible Party):
Robynne Braun, MD, PhD, University of Maryland, Baltimore

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.

Condition or disease Intervention/treatment Phase
Hemiparesis Stroke Sequelae Device: robot-assisted training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Neural Mechanisms of Motor Recovery With Technology Assisted Training for Post-stroke Hemiparesis
Estimated Study Start Date : November 1, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Arm Intervention/treatment
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.
Device: robot-assisted training
These training platforms use gamified training tasks to improve motor control in the hemiparetic arm
Other Names:
  • IMT InMotion Wrist Robot
  • IMT InMotion2 Shoulder-Elbow Robot
  • IMT InMotion2 Planar Robot




Primary Outcome Measures :
  1. Changes in cortical connectivity measures as assessed using MRI [ Time Frame: Baseline MRI will be collected at the time of study enrollment (for a total of up to 4 weeks during study enrollment) ]
    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.

  2. Changes in cortical connectivity measures as assessed using fNIRS [ Time Frame: 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) ]
    Cortical connectivity is assessed between bilateral primary motor areas, angular gyrus and parietal operculum.


Secondary Outcome Measures :
  1. Changes in arm kinematics (position) [ Time Frame: 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) ]
    Arm kinematics measures of position collected by the rehabilitation training technology devices

  2. Changes in arm kinematics (velocity) [ Time Frame: 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) ]
    Arm kinematics measures of velocity collected by the rehabilitation training technology devices

  3. Changes in arm kinematics (acceleration) [ Time Frame: 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) ]
    Arm kinematics measures of acceleration collected by the rehabilitation training technology devices

  4. Changes in Fugl-Myer Scores for the Upper Extremity ("FM-UE") [ Time Frame: At the time of enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment) ]
    Standardized bedside test examining the degree of motor impairment for the arm/hand. Scores range from 0 - 66 with higher scores representing better recovery.

  5. Changes in Action Research Arm Test [ Time Frame: 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). ]
    Standardized bedside test examining behavioral tasks for the arm/hand. Scores range from 0-57 points, with a maximum score of 57 points indicating better performance.

  6. Changes in Wolf Motor Function Test ("WMFT") [ Time Frame: 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). ]
    Standardized bedside test examining behavioral tasks for the arm/hand. Score Ranges Minimum 0 to Maximum 75; Lower scores are indicative of lower functioning levels.

  7. Changes in Shoulder Abduction Finger Extension ("SAFE") score [ Time Frame: At the time of enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment) ]
    Standardized bedside test examining strength of the arm/hand. Scores range from 0-10 with higher scores representing better strength.

  8. Changes in NIH Stroke Scale Score ("NIHSS") [ Time Frame: At the time of enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment) ]
    Standardized bedside test to assess stroke symptoms. Scores range from 0 - 42, where higher scores indicate greater symptom severity.

  9. Changes in Stroke Impact Scale ("SIS") [ Time Frame: 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) ]
    Standardized questionnaire examining patient perceptions of how stroke impacts their function and quality of life. Scores range from 0 to 100 with higher scores indicating a higher quality of life.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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Responsible Party: Robynne Braun, MD, PhD, Assistant Professor, Department of Neurology, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT05560867    
Other Study ID Numbers: HP-00093740
First Posted: September 29, 2022    Key Record Dates
Last Update Posted: October 26, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Robynne Braun, MD, PhD, University of Maryland, Baltimore:
stroke
robot-assisted rehabilitation
neural networks
fnirs
rehabilitation
Additional relevant MeSH terms:
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Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations