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Knee Biofeedback Rehabilitation Through Game Therapy (KneeBRIGHT)

Offene Rekrutierung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06090097 (KneeBRIGHT) ist eine interventionsstudie zur Untersuchung von Kniearthrose und hat den Status offene rekrutierung. Die Studie startete am 4. September 2024 und soll 60 Teilnehmer aufnehmen. Durchgeführt von Barron Associates, Inc. ist der Abschluss für 30. November 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 3. Dezember 2025 aktualisiert.
Kurzbeschreibung
The goal of this study is to learn about the effect of video-game based rehabilitation exercise for patients with knee osteoarthritis. The main question the study aims to answer is: do patients who exercise with the game have better functional outcomes and engagement compared to patients who do conventional exercise? Participants will complete 10 weeks of physical therapy exercise sessions that focus on quadriceps strengthening. Two sessions per week will be conducted in the clinic, and one session will be conducted at home each week. The interventional group will conduct all exercises using the KneeBRIGHT EMG sensors and game software. The control group will conduct all exercises following a standard physical therapy regimen. Researchers will compare knee function and engagement between the group who uses the game, and the group who does conventional exercise.
Ausführliche Beschreibung
The KneeBRIGHT game system will be evaluated in a 10-week single-blinded randomized controlled trial. The goals of this study are to: (1) assess improvements in functional outcomes following an exercise regimen conducted by KneeBRIGHT compared to conventional exercise; and (2) evaluate patient engagement during unsupervised, home-based exercises with and without the KneeBRIGHT software. Over the course of the study period, the knee OA participants will conduct physical therapy sessions with the physical therapist (PT) who enrolled them. The exercise regimen will implement each PT's standard of care, consisting of two weekly clinic sessions and one weekly home exercise session, for 10 weeks. Knee OA participants will be randomly assigned (via block randomization for each PT) to use either the KneeBRIGHT system for both clinic and home exercise, or to receive standard care with conventional exercise routines. Participants will conduct functional exercise assessments on study intake and again on study completion. Participants will also complete questionnaires focused on exercise engagement on study completion.
Offizieller Titel

Knee-Biofeedback Rehabilitation Interface for Game-based Home Therapy

Erkrankungen
Kniearthrose
Weitere Studien-IDs
  • KneeBRIGHT
  • KneeBRIGHT2B
NCT-Nummer
Studienbeginn (tatsächlich)
2024-09-04
Zuletzt aktualisiert
2025-12-03
Studienende (vorauss.)
2026-11-30
Geplante Rekrutierung
60
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
knee osteoarthritis, physical therapy, rehabilitation
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Einfach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellKneeBRIGHT Group
The interventional group will conduct all exercises during the 10-week therapy regimen using the KneeBRIGHT electromyogram sensors and game software.
Kneebright System
The KneeBRIGHT system includes electromyogram sensors and video game software that leads participants through physical therapy exercise.
Aktives VergleichspräparatControl Group
The control group will conduct all exercises following a standard physical therapy regimen.
Kontrollübung
The control group will complete a 10-week regimen of conventional PT exercise
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Knee Osteoarthritis Outcome Score
A multi-dimensional assessment that classifies knee outcomes into five categories: pain, symptoms, activities of daily living (ADL), sport, and quality of life
After 10 weeks (study completion)
Timed get-up-and-go score
In the timed up and go (TUG) test, subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again.
After 10 weeks (study completion)
6-minute walk test
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.
After 10 weeks (study completion)
Quadriceps strength
Quadriceps strength will be measured by recording isokinetic knee extension torque as measured by a dynamometer
After 10 weeks (study completion)
Patient Activation Model Scores
The Patient Activation Model (PAM) is an established, highly reliable, questionnaire that reflects a developmental model of patient engagement with their healthcare regimens
After 10 weeks (study completion)
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Patient technology acceptance
Participants will complete a questionnaire, designed based on the established Technology Acceptance Model to assess their level of technology acceptance.
After 10 weeks (study completion)
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
30 Years
Zugelassene Geschlechter
Alle
  • diagnosis via x-ray, with a score of at least 2 (out of 4) on the Kellgren-Lawrence OA scoring system; independent ambulation without assistive device

  • individuals who have psychiatric or cognitive impairment (e.g., dementia) that interferes with their ability to follow instructions or provide voluntary consent; symptomatic spine, hip, ankle, or foot disease other than OA that would interfere with assessment of the knee.
Barron Associates, Inc. logoBarron Associates, Inc.
University of North Carolina, Chapel Hill logoUniversität von North Carolina, Chapel Hill245 aktive klinische Studien zum Erkunden
Zentrale Studienkontakte
Kontakt: Eileen Krepkovich, MS, 4349731215, [email protected]
1 Studienstandorte in 1 Ländern

North Carolina

University of North Carolina Chapel Hill, Chapel Hill, North Carolina, 27599, United States
Joe M Hart, PhD, Kontakt, 919-966-9166, [email protected]
Joe M Hart, PhD, Hauptprüfer
Carla Hill, DPT, Prüfarzt
Offene Rekrutierung