Automated Stereognosis to Treat Loss of Tactile Function After Brain Injury

NCT ID: NCT05740553

Last Updated: 2023-03-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2022-06-06

Brief Summary

Researchers aim to determine whether the ReTrieve system for tactile training can improve tactile function (sense of touch) in the hand after brain injury when used at home for 6 weeks.

Detailed Description

All participants who have been found eligible for this study and given informed consent will be randomized into two groups- either participants will begin ReTrieve training immediately following an initial assessment, or wait 8 weeks before beginning training.

During the study, participants will have a ReTrieve tactile training system delivered home for use over 6 weeks. Investigators will take three days to teach participants how to use the system. Each week for the remainder of the 6 weeks, participants will use this system for 4+ days per week on their own, and for 1 day supervised. During each supervised day, participants will complete approximately 1 hour of training while supervised over video chat with researchers.

Participants' tactile function will be assessed at three separate time points: once within one week before beginning training, once within one week after completing training, as well as once either 8 weeks before or 8 weeks after the training. This assessment has a required survey component, as well as an optional in-person clinical assessment component.

Conditions

Stroke; Chronic Brain Injury; Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Training First

Group Type: EXPERIMENTAL

ReTrieve Automated Stereognosis System

Intervention Type: DEVICE

An automated tactile training system that may help patients recover lost tactile function after brain injury.

Training Second

Group Type: EXPERIMENTAL

ReTrieve Automated Stereognosis System

Intervention Type: DEVICE

An automated tactile training system that may help patients recover lost tactile function after brain injury.

Interventions

ReTrieve Automated Stereognosis System

An automated tactile training system that may help patients recover lost tactile function after brain injury.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• English speaking
• Be able to communicate and consent for themselves
• Have experienced a brain injury more than 6 months prior to the date of study participation
• Have chronic tactile deficits in at least one hand as a result of their brain injury
• Have sufficient motor ability in their affected hand(s) to complete reach and grasp tasks
• Have sufficient motor ability in their affected hand(s) to raise their arms above their head
• Have sufficient motor ability in their affected hand(s) to hold objects
• Have wireless internet and a laptop or mobile device at home for video conferencing
• Live in the greater Dallas area

Exclusion Criteria

• Significant cognitive deficits that would preclude them from understanding instructions
• Significant communication deficits that would preclude them from consenting for themselves

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas at Dallas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Texas at Dallas

Richardson, Texas, United States

Countries

United States

Other Identifiers

21-12

Identifier Type: -

Identifier Source: org_study_id