Knee Biofeedback Rehabilitation Through Game Therapy

Официальное название

Knee-Biofeedback Rehabilitation Interface for Game-based Home Therapy

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство KneeBRIGHT System
  The KneeBRIGHT system includes electromyogram sensors and video game software that leads participants through physical therapy exercise.
• Другое Control Exercise
  The control group will complete a 10-week regimen of conventional PT exercise

Первичные конечные точки

• Knee Osteoarthritis Outcome Score [Срок оценки: After 10 weeks (study completion)]
• Timed get-up-and-go score [Срок оценки: After 10 weeks (study completion)]
• 6-minute walk test [Срок оценки: After 10 weeks (study completion)]
• Quadriceps strength [Срок оценки: After 10 weeks (study completion)]
• Patient Activation Model Scores [Срок оценки: After 10 weeks (study completion)]

Вторичные конечные точки (1)

• Patient technology acceptance [Срок оценки: After 10 weeks (study completion)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of North Carolina Chapel Hill — Chapel Hill

Публикации

• Norbekov A, Krepkovich E, Hill C, Berkoff D, Adams N, Kelly DK, Jackman A, Kane J, Hanson A, Hart JM. Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy (KneeBRIGHT) in Patients with Knee Osteoarthritis: A Protocol for Evaluating the KneeBRIGHT System via Randomized, Controlled Clinical Trial. Adv Rehabil Sci Pract. 2026 Mar 27;15:27536351261435821. doi: 10.1177/2753635126143582 PMID 41908080

Идентификаторы

NCT: NCT06090097 · KneeBRIGHT2B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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