- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Julie F Stowell, DPT
- Telefonnummer: 4046035049
- E-post: julie.stowell@shepherd.org
Studieorter
-
-
Georgia
-
Atlanta, Georgia, Förenta staterna, 30309
- Rekrytering
- Shepherd Center
-
Kontakt:
- Julie F Stowell, DPT
- Telefonnummer: 404-603-5049
- E-post: julie.stowell@shepherd.org
-
Huvudutredare:
- Julie F Stowell, DPT
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Arm 1
Gait training |
6-week training program with 2 training sessions each week |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Spatiotemporal metrics of gait
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
|
Spatiotemporal metrics of gait
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
|
Spatiotemporal metrics of gait
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Fear of falling (FOF)
Tidsram: Surveys will be conducted at the initial visit, week 2, 5, 8, and 12.
|
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.
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1111
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Shepherd Center will publish findings as appropriate and will maintain confidential records as necessary.
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