Determinants of the Effectiveness of Robot-assisted Hand Movement Training

University of California Irvine (UCI)

Status: Active, not recruiting

Conditions: Cerebrovascular Accident (CVA); Stroke, Ischemic

Treatments: Device: New FINGER

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04818073

476

2R01HD062744-06

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Group A

Experimental group

Description:

Participants with undergo new FINGER robotic training with no physical assistance 3 times a week for a period of 3 weeks.

Treatment:

Device: New FINGER

Group B

Experimental group

Description:

Participants will undergo new FINGER robotic training with physical assistance 3 times a week for a period of 3 weeks.

Treatment:

Device: New FINGER

Group C

Experimental group

Description:

Participants will undergo new FINGER robotic training with physical assistance and proprioceptive exercises 3 times a week for a period of 3 weeks.

Treatment:

Device: New FINGER