Automated Stereognosis to Treat Loss of Tactile Function After Brain Injury

Stroke Clinical Trial

— ReTrieve  

Official title:

Using the ReTrieve Automated Stereognosis System to Treat Loss of Tactile Function After Brain Injury

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05740553
• Other study ID #: 21-12
• Status: Terminated
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: June 6, 2022

Study information

• Verified date: January 2023
• Source: The University of Texas at Dallas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 6, 2022
• Est. primary completion date: June 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury, Chronic
• Peripheral Nervous System Diseases
• Peripheral Neuropathy
• Stroke
• Wounds and Injuries

Intervention

Device:
• ReTrieve Automated Stereognosis System
An automated tactile training system that may help patients recover lost tactile function after brain injury.

Locations

Country	Name	City	State
United States	University of Texas at Dallas	Richardson	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas at Dallas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Retrievals	The majority of participants should manage at least 4500 retrievals over their ~30 hours of system use	6-8 weeks
Primary	Number of Retrievals per Hour	The majority of participants should achieve at least 700 retrievals per hour by the end of training	6-8 weeks
Secondary	Improved Tactile Function	Participants should show a significantly greater increase in tactile function as measured by the French variation of the Upper Extremity subscore of the Erasmus modified Nottingham Sensory Assessment [High scores are better. Assessment performed for both hands. Scores range from 0-48 (0-24 per hand) on somesthesia, and 0-20 (0-10) on stereognosis. Total score range per participant is 0-68 (0-34 per hand)] when measured over their 6-8 weeks of tactile training than when measured over their 8 weeks without tactile training.	6-8 weeks
Secondary	Improved Perceived Tactile Function	Participants should show a significantly greater increase in their perceived tactile function score as measured by the 'ABILHAND' questionnaire [High scores are better. Answered for only most impaired hand. 23 activities scored 0(impossible)-2(easy) Score range 0-46] combined with a modified version of the Sensory Perception Quotient (modified to focus on tactile and remove temperature) [High scores are better. Score range 0-18. Answered for only most impaired hand.] when measured over their 6-8 weeks of tactile training than when measured over their 8 weeks without tactile training.	6-8 weeks