Clinical trial NCT04818073: Determinants of the Effectiveness of Robot-assisted Hand Movement Training
Official title: Determinants of the Effectiveness of Robot-assisted Hand Movement Training
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke, Ischemic
Cerebrovascular Accident (CVA)
Keywords: Rehabilitation
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: University of Idaho
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators would like to investigate the effectiveness of somatosensory training for robot-assisted hand motor rehabilitation after stroke.

Detailed description: From previous studies, the investigators learned that stroke survivors with impaired finger proprioception did not achieve as large a functional benefit from robotic finger training. For this study, the investigators would like to determine if and the extent of finger proprioception can be improved through targeted robotic proprioceptive training combined with robotic finger movement training. The investigators would also include imagining studies via Electroencephalogram (EEG) and other baseline predictors to provide insight to determine who responds best to proprioceptive training.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 85 years
* Suffered from a single ischemic stroke (radiologically confirmed) at least 6-months prior to enrollment
* An ability to score at least 3 blocks on the Box and Block Test

Exclusion Criteria:

* A substantial decrease in alertness, language reception or attention
* Pregnant or lactating
* Advanced liver, kidney, cardiac or pulmonary disease
* Plan to alter any current participation in other rehabilitation therapy in the time period of the study
* A terminal medical diagnosis consistent with survival \< 1 year
* Coexistent major neurological disease
* Coexistent major psychiatric disease
* A history of significant alcohol or drug abuse in the prior 3 years
* Current enrollment in another study related to stroke or stroke recovery
* Any other medical contraindication to participation in this study evaluated by our team physician.

Primary outcomes:
measure: Box and Blocks Test
timeFrame: From baseline to 1-month post intervention
Secondary outcomes:
measure: Fugl-Meyer Motor Assessment of the Upper Extremity
timeFrame: From baseline to 1-month post intervention
measure: Motor Activity Log
timeFrame: From baseline to 1-month post intervention
measure: Changes in finger proprioception measured using the Crisscross Assessment.
timeFrame: From baseline to 1-month post intervention
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: David Reinkensmeyer, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rowe JB, Chan V, Ingemanson ML, Cramer SC, Wolbrecht ET, Reinkensmeyer DJ. Robotic Assistance for Training Finger Movement Using a Hebbian Model: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2017 Aug;31(8):769-780. doi: 10.1177/1545968317721975.
citation: Ingemanson ML, Rowe JB, Chan V, Wolbrecht ET, Cramer SC, Reinkensmeyer DJ. Use of a robotic device to measure age-related decline in finger proprioception. Exp Brain Res. 2016 Jan;234(1):83-93. doi: 10.1007/s00221-015-4440-4. Epub 2015 Sep 16.