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Automated Stereognosis to Treat Loss of Tactile Function After Brain Injury (ReTrieve)

Primary Purpose

Stroke, Chronic Brain Injury, Peripheral Neuropathy

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ReTrieve Automated Stereognosis System
Sponsored by
The University of Texas at Dallas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas at Dallas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Training First

Training Second

Arm Description

Outcomes

Primary Outcome Measures

Number of Retrievals
The majority of participants should manage at least 4500 retrievals over their ~30 hours of system use
Number of Retrievals per Hour
The majority of participants should achieve at least 700 retrievals per hour by the end of training

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 13, 2023
Last Updated
March 2, 2023
Sponsor
The University of Texas at Dallas
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1. Study Identification

Unique Protocol Identification Number
NCT05740553
Brief Title
Automated Stereognosis to Treat Loss of Tactile Function After Brain Injury
Acronym
ReTrieve
Official Title
Using the ReTrieve Automated Stereognosis System to Treat Loss of Tactile Function After Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Inadequate participant recruitment (potentially due to COVID-19)
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
June 6, 2022 (Actual)
Study Completion Date
June 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas at Dallas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Chronic Brain Injury, Peripheral Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training First
Arm Type
Experimental
Arm Title
Training Second
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ReTrieve Automated Stereognosis System
Intervention Description
An automated tactile training system that may help patients recover lost tactile function after brain injury.
Primary Outcome Measure Information:
Title
Number of Retrievals
Description
The majority of participants should manage at least 4500 retrievals over their ~30 hours of system use
Time Frame
6-8 weeks
Title
Number of Retrievals per Hour
Description
The majority of participants should achieve at least 700 retrievals per hour by the end of training
Time Frame
6-8 weeks
Secondary Outcome Measure Information:
Title
Improved Tactile Function
Description
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.
Time Frame
6-8 weeks
Title
Improved Perceived Tactile Function
Description
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.
Time Frame
6-8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Texas at Dallas
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Automated Stereognosis to Treat Loss of Tactile Function After Brain Injury

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