ReTrieve: Automated Stereognosis to Treat Loss of Tactile Function After Brain Injury
Study Details
Study Description
Brief Summary
We 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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. We 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 by our 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Training First
|
Device: ReTrieve Automated Stereognosis System
An automated tactile training system that may help patients recover lost tactile function after brain injury.
|
| Experimental: Training Second
|
Device: ReTrieve Automated Stereognosis System
An automated tactile training system that may help patients recover lost tactile function after brain injury.
|
Outcome Measures
Primary Outcome Measures
- Number of Retrievals [6-8 weeks]
The majority of participants should manage at least 4500 retrievals over their ~30 hours of system use
- Retrievals per Hour [6-8 weeks]
The majority of participants should achieve at least 700 retrievals per hour by the end of training
Secondary Outcome Measures
- Improved Tactile Function [6-8 weeks]
Participants should show a significantly greater increase in tactile function as measured by the Erasmus modified Nottingham Sensory Assessment when measured over their 6-8 weeks of tactile training than when measured over their 8 weeks without tactile training.
- Improved Perceived Tactile Function [6-8 weeks]
Participants should show a significantly greater increase in their perceived tactile function score as measured by the ABILHAND questionnaire combined with a modified version of the Sensory Perception Quotient when measured over their 6-8 weeks of tactile training than when measured over their 8 weeks without tactile training.
Eligibility Criteria
Criteria
Inclusion Criteria:
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English speaking
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Be able to communicate and consent for themselves
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Have experienced a brain injury more than 6 months prior to the date of study participation
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Have chronic tactile deficits in at least one hand as a result of their brain injury
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Have sufficient motor ability in their affected hand(s) to complete reach and grasp tasks
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Have sufficient motor ability in their affected hand(s) to raise their arms above their head
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Have sufficient motor ability in their affected hand(s) to hold objects
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Have wireless internet and a laptop or mobile device at home for video conferencing
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Live in the greater Dallas area
Exclusion Criteria:
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Significant cognitive deficits that would preclude them from understanding instructions
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Significant communication deficits that would preclude them from consenting for themselves
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Texas at Dallas | Richardson | Texas | United States | 75080 |
Sponsors and Collaborators
- The University of Texas at Dallas
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-12