NCT04930822Befejeződött
Evaluation of Bioness Integrated Therapy System (BITS) Touch Screen Technology to Improve Field Awareness
Does Bioness Integrated Therapy System (BITS) Touch Screen Technology Improve Field Awareness to Inpatients With Neurological Visual Field Deficits
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 23.
Rövid összefoglaló (regiszter, angolul)
The Bioness Integrated Therapy System (BITS) (Bioness Inc. Valencia, CA) Touch Screen is an FDA approved device comprised of an interactive touchscreen and diverse program options to challenge patients through the use of visual motor activities, visual and auditory processing, cognitive skills, and endurance training. The purpose of this study is to enroll a small group of adults currently undergoing inpatient rehabilitation, who were admitted for an acute neurological event and present with an acute neurological visual field impairment. The primary objective is to compare any increase in visual field awareness using a prescribed regimen consisting of conventional vision exercises compared with a regimen using BITS touch screen technology. Participants will be alternately assigned into "A" and "B" groups upon enrollment. The control group "A" will be prescribed conventional (table top, pen and paper) vision interventions provided by an occupational therapist and will receive pre- and post- assessment of visual field awareness. Treatment group "B" will include a prescribed regimen with use of BITS touch screen technology. Group B participants will receive the same pre- and post- assessment of visual field awareness as Group A participants. The hypothesis is that incorporation of the BITS touch screen technology, being more interactive, will result in better outcomes for visual field awareness. This is an unblinded quasi-randomized control trial that will determine best treatment intervention for visual field impairment. Safety will be measured by the number of reported adverse events. The study period will include 6 sessions per participant, conducted at one site, with the objective of enrolling at least 30 participants to have 15 participants in each study group.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 37 (tényleges)
- Első benyújtás
- 2021. jún. 11.
- Kezdés
- 2021. jan. 8.
- Elsődleges befejezés
- 2024. jún. 12.
- Fő szponzor
- Gaylord Hospital, Inc
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT04930822
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 37
- 2021. jan. 8. és az elsődleges befejezés (2024. jún. 12.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Previous significant visual impairment impacting visual fields or resulting in legal blindness in past medical history
- Currently on a ventilator for respiratory support
- Unstable vital signs or deemed inappropriate to participate in therapy per Medical Staff
- Concurrent severe neurological pathology/disease or stroke within 72 hours.
Más betegség
- Uncontrolled or new (within 24 hours) arrhythmias.
- Unresolved or new (within 24 hours) deep vein thrombosis.
Egyéb
- Severe cognitive impairments: Unable to follow one step directions, inability to communicate pain, or to stop intervention if needed
- Quadriparesis
- Re-admitted to Acute Care and do not return within 1 week
- Any reason the physician may deem as harmful to the participant to enroll or continue in the study.
Kiket keres a vizsgálat
- Adults, 18 years or older who are able to provide consent or have Power of Attorney (POA) able to consent.
- Must have an acute or subacute (diagnosed within the last 3 months) neurological diagnosis with a visual field deficit as verified by occupational therapist via confrontation testing.
- Admitted for inpatient rehabilitation
- Demonstrate the ability to follow 1 step directions
- Demonstrate sufficient upper extremity strength (as deemed appropriate by occupational therapist) to utilize BITS touch screen technology
- Ability to tolerate at least 30 minutes of intervention at a seated wheelchair level.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Gaylord Hospital | Wallingford | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.