- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07927439
Investigating the Impact of Treadmill-integrated Virtual Reality Training on Walking Outside the Clinic
Investigating the Acute and Long-term Effects of Treadmill-integrated Virtual Reality (VR) Training on Real-World Mobility and Fall-Related Outcomes in People With Multiple Sclerosis
This study will test whether a treadmill-based virtual reality walking program is safe, practical, and helpful for people with multiple sclerosis (MS). Participants will complete a 6-week training program and wear smart socks that measure how they walk before, during, and after the program. The study will also track changes in balance, fatigue, fall risk, fear of falling, confidence with walking, and overall quality of life.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
People with multiple sclerosis (MS) often have trouble with walking and balance, which can increase the risk of falls and make daily life harder. While therapy can improve walking in a clinic, it is not always clear if those improvements carry over to real life at home or in the community. In addition, most walking tests are done over short periods and may not show how a person moves throughout the day. This study will look at new ways to better understand and improve walking in everyday settings. Researchers will use a treadmill-based virtual reality program, along with smart socks that track walking during daily activities. This approach will help show how people respond to training and whether those changes last outside the clinic. Standard care for people with MS usually includes physical therapy and clinic-based walking tests, but these may miss important changes in daily movement.
Participants will be asked to provide basic health information and complete surveys about their walking, fatigue, balance, thinking, and quality of life at different times during the study. They will also complete simple walking and balance tests to measure their mobility. As part of the study, participants will take part in a 6-week treadmill-based virtual reality training program, with two sessions each week. During the study, they will wear smart socks that collect information about how they walk in their daily lives, including before, during, and after the training program. These socks will track how often they walk, how steady they are, and how their walking changes over time. After the training ends, participants will continue wearing the socks for several weeks so researchers can see if improvements last. The results will help researchers learn if this approach can improve walking, lower fall risk, and support better mobility and quality of life for people living with MS.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Julie F Stowell, DPT
- Telefonszám: 4046035049
- E-mail: julie.stowell@shepherd.org
Tanulmányi helyek
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Georgia
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Atlanta, Georgia, Egyesült Államok, 30309
- Toborzás
- Shepherd Center
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Kapcsolatba lépni:
- Julie F Stowell, DPT
- Telefonszám: 404-603-5049
- E-mail: julie.stowell@shepherd.org
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Kutatásvezető:
- Julie F Stowell, DPT
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- Have a clinically confirmed diagnosis of multiple sclerosis (MS).
- Be 18 years of age or older.
- Demonstrate ≥10% variability in stride length, step length, or gait asymmetry.
- Can ambulate without an assistive device, with a unilateral, or with a bilateral assistive device.
- Demonstrate no more than mild cognitive impairment, indicated by the Mini-Mental State Exam (score >19).
- Possess adequate cognitive function to understand and follow research instructions.
- Be able to safely participate in the study and training procedures as determined by study staff.
- Be fluent in English and able to communicate discomfort, fatigue, or pain in English.
- Be able to travel to Shepherd Center to complete key assessment points in-person and for in-person training sessions twice per week.
Exclusion Criteria:
- Have a diagnosis of any other neurological condition or recent orthopedic conditions that affects gait, balance, or mobility.
- Exhibit <10% variability in stride length, step length, or gait asymmetry.
- Are unable to ambulate (i.e. wheelchair bound or bedbound individuals).
- Have legal blindness or severe visual impairment that would interfere with virtual reality engagement or safe ambulation.
- Have a body weight exceeding 300 lbs., which exceeds the safety limits of the treadmill and body weight support system.
- Have uncontrolled or untreated hypertension, hypotension, or angina.
- Have a past or current history of epilepsy or any other type of seizure disorder, whether controlled or uncontrolled.
- Have undergone major surgery within the past 6 months or hospitalization within the past 3 months.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: Arm 1
Gait training |
6-week training program with 2 training sessions each week |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Spatiotemporal metrics of gait
Időkeret: Initial visit to the end of the program in 12 weeks
|
step length (m) |
Initial visit to the end of the program in 12 weeks
|
|
Spatiotemporal metrics of gait
Időkeret: Initial visit to the end of the program in 12 weeks
|
stride length (m) |
Initial visit to the end of the program in 12 weeks
|
|
Spatiotemporal metrics of gait
Időkeret: Initial visit to the end of the program in 12 weeks
|
step time (s) |
Initial visit to the end of the program in 12 weeks
|
|
Spatiotemporal metrics of gait
Időkeret: Initial visit to the end of the program in 12 weeks
|
single support time (s) |
Initial visit to the end of the program in 12 weeks
|
|
Spatiotemporal metrics of gait
Időkeret: Initial visit to the end of the program in 12 weeks
|
double support time (s) |
Initial visit to the end of the program in 12 weeks
|
|
Spatiotemporal metrics of gait
Időkeret: Initial visit to the end of the program in 12 weeks
|
gait cycle (s) |
Initial visit to the end of the program in 12 weeks
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Spatiotemporal metrics of gait
Időkeret: Initial visit to the end of the program in 12 weeks
|
cadence (steps/s) |
Initial visit to the end of the program in 12 weeks
|
|
Spatiotemporal metrics of gait
Időkeret: Initial visit to the end of the program in 12 weeks
|
stance time (s) |
Initial visit to the end of the program in 12 weeks
|
|
Spatiotemporal metrics of gait
Időkeret: Initial visit to the end of the program in 12 weeks
|
speed(m/s) |
Initial visit to the end of the program in 12 weeks
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Spatiotemporal metrics of gait
Időkeret: Initial visit to the end of the program in 12 weeks
|
swing time (s) |
Initial visit to the end of the program in 12 weeks
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Fear of falling (FOF)
Időkeret: Surveys will be conducted at the initial visit, week 2, 5, 8, and 12.
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FOF as determined by Falls Efficacy Scale-International (FES-I); Scale: Not at all concerned = 1, Somewhat concerned = 2, Fairly concerned = 3, Very concerned = 4; Lowest score = 16, Highest score = 64, lower scores indicated less FOF (better), higher scores indicated more FOF (worse), total score divided by 64. |
Surveys will be conducted at the initial visit, week 2, 5, 8, and 12.
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Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 1111
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
Shepherd Center will publish findings as appropriate and will maintain confidential records as necessary.
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