Clinical trial NCT05560867: Neural Mechanisms of Motor Recovery With Technology Assisted Training
Official title: Neural Mechanisms of Motor Recovery With Technology Assisted Training for Post-stroke Hemiparesis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hemiparesis
Stroke Sequelae
Keywords: stroke
robot-assisted rehabilitation
neural networks
fnirs
rehabilitation
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Changes in cortical connectivity measures as assessed using MRI
timeFrame: Baseline MRI will be collected at the time of study enrollment (for a total of up to 4 weeks during study enrollment)
measure: Changes in cortical connectivity measures as assessed using fNIRS
timeFrame: 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:
measure: Changes in arm kinematics (position)
timeFrame: 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)
measure: Changes in arm kinematics (velocity)
timeFrame: 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)
measure: Changes in arm kinematics (acceleration)
timeFrame: 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)
measure: Changes in Fugl-Myer Scores for the Upper Extremity ("FM-UE")
timeFrame: At the time of enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
measure: Changes in Action Research Arm Test
timeFrame: 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).
measure: Changes in Wolf Motor Function Test ("WMFT")
timeFrame: 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).
measure: Changes in Shoulder Abduction Finger Extension ("SAFE") score
timeFrame: At the time of enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
measure: Changes in NIH Stroke Scale Score ("NIHSS")
timeFrame: At the time of enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
measure: Changes in Stroke Impact Scale ("SIS")
timeFrame: 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)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
References: