Clinical trial NCT05740553: Automated Stereognosis to Treat Loss of Tactile Function After Brain Injury
Official title: Using the ReTrieve Automated Stereognosis System to Treat Loss of Tactile Function After Brain Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Chronic Brain Injury
Peripheral Neuropathy
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants complete tactile training for 6-8 weeks, and complete no additional training for 8 weeks. One group will begin with tactile training, and the other group will begin with no additional training, then they will swap. At each time point (before portion 1, after portion 1, and after portion 2) their tactile function will be assessed.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Retrievals
timeFrame: 6-8 weeks
measure: Number of Retrievals per Hour
timeFrame: 6-8 weeks
Secondary outcomes:
measure: Improved Tactile Function
timeFrame: 6-8 weeks
measure: Improved Perceived Tactile Function
timeFrame: 6-8 weeks
Other outcomes:
Locations:
city: Richardson
country: United States
facility: University of Texas at Dallas
state: Texas
Study officials:
References: