Imerzní léčení: Terapeutický potenciál virtuální reality
Pohlcující léčení: Terapeutický potenciál virtuální reality ve fantomových končetinách
Phantom limb pain (PLP) is a significant and pervasive issue among upper limb amputees, severely impacting their quality of life. The literature delineating prevalence of upper versus lower limb amputations is limited, but the prevalence of total amputations in the United States is estimated to reach 3 million individuals by 2050, with approximately 185,000 new cases annually. PLP affects 60-68% of these patients, leading to heightened levels of anxiety, depression, and reduced overall well-being.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Although studies exploring the efficacy of VR therapy for PLP have reported positive outcomes, several limitations, such as small sample sizes, lack of randomization, and inconsistent treatment protocols, have impeded widespread adoption of these innovative approaches. Additionally, the literature does not sufficiently delineate which aspects of the phantom limb experience may be addressed with VR therapy. To overcome these limitations and optimize treatment efficacy, it is crucial to gain a comprehensive understanding of the phantom limb experience, including both somatosensory and kinesthesia-related symptoms. Additionally, this study will address these limitations by employing a larger sample size, rigorous methodology, and a standardized treatment protocol.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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North Carolina
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Charlotte, North Carolina, Spojené státy, 28207
- OrthoCarolina Hand Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- History of major limb amputation
- Age > 18 years old
- Presence of phantom limb pain or negative phantom sensation(s)
Exclusion Criteria:
- Active mental illness, neurological disease, or cognitive impairment that would interfere with survey completion
- Those without phantom limb pain or negative phantom limb sensations
- Non-English speaking
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Virtual Reality (VR) Intervention
Individuals undergoing virtual reality therapy intervention |
6 2 times weekly sessions of 30-minute VR therapy in the office with pre- and post-intervention surveys
Ostatní jména:
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Falešný srovnávač: Matched Control
The matched controls will receive standard care without the VR intervention |
taking the same surveys as the VR intervention group on a weekly basis for 6 weeks
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
Časové okno: Baseline
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Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily. |
Baseline
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Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
Časové okno: Week 1
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Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily. |
Week 1
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Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
Časové okno: Week 2
|
Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily. |
Week 2
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Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
Časové okno: Week 3
|
Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily. |
Week 3
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Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
Časové okno: Week 6
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Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily. |
Week 6
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Brief Pain Inventory (BPI) scores
Časové okno: Hour 24
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Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain - Scores range from 0 to 10 with higher scores indicating greater pain interference. |
Hour 24
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Change in Short-Form McGill Pain Questionnaire (SF-MPQ) scores
Časové okno: Week 6
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A short form of the McGill Pain Questionnaire (SF-MPQ) has been developed. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Consists of 22 different descriptors of pain and each item is rated based on a 0-10 scale with 0 equal to no pain and 10 equal to the worst pain ever during the past week. The total score is calculated by summing 22 individual scores. |
Week 6
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Phantom Limb Experience Survey score
Časové okno: Baseline
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it is qualitative and there is no good or bad, this is just to define the population and better characterize phantom limb experience - assesses presence, onset, location, character, intensity, triggers, and treatment of phantom limb sensations and phantom limb pain. Includes questions on phantom limb posture, movement, size changes, and telescoping. |
Baseline
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Change in Virtual Reality (VR) Therapy Survey scores
Časové okno: Week 6
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There are several questions within this survey to assess attitude towards VR, which activities are favored and then the effect VR had on them. There is a mix of qualitative questions and quantitative. Quantitative questions are on Likert Scale 1-5. An interval change of +1 on Likert scale would be "good" for question on posture, control over limb. For how long the therapy effect lasts after session is over, it will vary from hours to days to weeks (which is why all descriptors are in there). Even if it lasted 1 hour this would be considered "good". |
Week 6
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System Usability Scale
Časové okno: Week 6
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Assesses subjective usability and satisfaction with the VR system - A perfect score of 100% signifies flawless usability and an exceptional user experience. The average SUS score is 68, and scores up to 70% are generally considered good; a good sus score indicates a decent level of usability. |
Week 6
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Simulator Sickness Questionnaire
Časové okno: Week 6
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negligible (< 5), minimal (5 - 10), significant (10 - 15), and concerning (15 - 20) symptoms. A simulator resulting in total scores above 20 is considered "bad" |
Week 6
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Change in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) scores
Časové okno: Week 6
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Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions.EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state |
Week 6
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Glenn Gaston, MD, Atrium Health Musculoskeletal Institute
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Bolest
- Neurologické projevy
- Nemoci nervového systému
- Pooperační komplikace
- Patologické procesy
- Neurobehaviorální projevy
- Poruchy vnímání
- Bolest, pooperační
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Agnosia
- Fantomová končetina
- Vyšetřovací techniky
- Epidemiologický výzkumný návrh
- Epidemiologické metody
- Návrh výzkumu
- Metody
- Kontrolní skupiny
Další identifikační čísla studie
- IRB00100006
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Individual Participant Data that underlie the results reported in this article, after deidentification
Časový rámec sdílení IPD
Beginning 3 months and ending 5 years following article publication
Kritéria přístupu pro sdílení IPD
Researchers who provide a methodologically sound proposal
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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