Determinants of the Effectiveness of Robot-assisted Hand Movement Training

Stroke, Ischemic Clinical Trial

Official title:

Determinants of the Effectiveness of Robot-assisted Hand Movement Training

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04818073
• Other study ID #: 476
• Secondary ID: 2R01HD062744-06
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: November 2023
• Source: University of California, Irvine
• Contact: Vicky Chan, PT, DPT
• Phone: (949) 824-8423
• Email: vchan2[@]uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebrovascular Accident (CVA)
• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Device:
• New FINGER
New FINGER exoskeleton is a robotic device that can provide assistance and resistance to thumb and finger movement

Locations

Country	Name	City	State
United States	University of California Irvine	Irvine	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Irvine	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Idaho

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Box and Blocks Test	We compare the change of Box and Block Test scores from baseline evaluation to 1-month post intervention. Participants are instructed to move as many blocks as possible, one at a time, from one compartment in a box to a second compartment over a divider for a period of 60 seconds; each block that is moved is counted, and multiple blocks moved at the same time are counted as a single block. The higher scores indicate a better outcome.	From baseline to 1-month post intervention
Secondary	Fugl-Meyer Motor Assessment of the Upper Extremity	We will measure the change of the Fugl-Meyer Motor Assessment scores from the baseline evaluation to 1-month post intervention. Fugl-Meyer is a 66-point scale measuring the movement pattern of upper extremities. The higher scores indicate a better outcome.	From baseline to 1-month post intervention
Secondary	Motor Activity Log	We will measure the change of the Motor Activity Log (MAL) mean scores from the baseline evaluation to 1-month post intervention. The Motor Activity Log is a 30 questionnaire that collect subjective measure of an individual's real life functional upper limb performance. The higher scores indicate a better outcome.	From baseline to 1-month post intervention
Secondary	Changes in finger proprioception measured using the Crisscross Assessment.	We will measure the change in finger proprioception scores from the baseline evaluation to 1-month post intervention. Finger proprioception is measured by using the FINGER Crisscross Assessment which we slowly move the index and middle fingers with the FINGER robot past each other without any visual input. We then ask study participants to press a key when they feel the fingers are overlapped. Finger proprioception is measured by the error which will be quantified as the mean magnitude of finger separation error at the metacarpal joint when the key is pressed. The lower scores indicate a better outcome.	From baseline to 1-month post intervention