Mobile-Based Telerehabilitation With Sensors for Adherence and Efficacy in Chronic Patellofemoral Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- The primary outcome was device-recorded training adherence
研究概览
简要总结
This study is a prospective, single-center trial involving 174 patients diagnosed with patellofemoral pain. The study adhered to ethical guidelines and obtained informed consent from all participants. Participants were randomly assigned to receive face-to-face remote rehabilitation guidance either 1 time, 3 times, or 6 times. The primary outcome was device-recorded training adherence, defined as cumulative total training time (hours) and mean weekly training time (hours/week) over the first 6 weeks of independent home-based telerehabilitation.Self-reported adherence was measured using the Exercise Adherence Rating Scale (EARS) at week 6 (i.e., 6 weeks after the participant completed their final face-to-face tutorial).ain intensity during daily activities and squatting at 60° was measured using the Visual Analog Scale (VAS; 0-10);7 quadriceps muscle strength (concentric and eccentric peak torque) was evaluated using isokinetic dynamometry; knee function was assessed with the Kujala Patellofemoral Score (0-100); fatigue was measured using the Fatigue Severity Scale (FSS; 9 items, 7 points each). Additionally, a closed-ended adherence survey captured participant perceptions of factors influencing adherence
详细描述
The inestigators conducted a forward-looking, single-center pilot study with a follow-up period of 8 weeks. The study recruited 174 patients diagnosed with patellofemoral pain (PFP) by a professional sports physician at the Department of Sports Medicine, Peking University Third Hospital, between June and August 2024. The study adhered to the principles of the Declaration of Helsinki and was approved by the Research Ethics Committee of Peking University Third Hospital. Although this is a pilot study, the inestigators strictly followed the CONSORT guidelines. All participants signed an informed consent form and completed home rehabilitation interventions.
Inclusion and Exclusion Criteria During the trial, an investigator not involved in the study used an electronically generated random sequence to assign patients to three groups. Two professional physical therapists (N.C and S.R) were responsible for assessing and supervising the accuracy of the project and were unaware of the grouping details.
Interventions After randomization, participants received a package containing two wearable motion sensors, a charger, resistance bands, and a manual. Additionally, the rehabilitation software provided lectures and Q&A sessions related to the condition, accessible via Android or iOS platforms. All data collected by the sensors were strictly encrypted to protect patient information and privacy. Each participant was assigned a therapist for home rehabilitation support, and a follow-up function via the software or telephone was used to remind patients who missed three remote rehabilitation sessions.
Before starting home rehabilitation, patients attended a briefing at the hospital. Participants were divided into three groups: Group 1 received 1 face-to-face remote rehabilitation tutorial (OST), Group 2 received 3 face-to-face remote rehabilitation tutorials (TST), and Group 3 received 6 face-to-face remote rehabilitation tutorials (SST). Each session lasted 40 minutes and was conducted three times a week (on Tuesday, Thursday, and Saturday). Following the briefing, patients performed home remote rehabilitation training on the same day, with each session lasting 40 minutes. The remote rehabilitation program included muscle strengthening, flexibility stretching, and movement quality training.
Primary Outcomes. The primary outcome was device-recorded training adherence, defined as cumulative total training time (hours) and mean weekly training time (hours/week) over the first 6 weeks of independent home-based telerehabilitation. Data recording commenced immediately after each participant completed his or her final face-to-face tutorial, thereby isolating adherence to the unsupervised home program. Because the three groups differed in the number of tutorials received, the calendar start date of the 6-week recording window varied: OST participants began the recording window after session 1; TST participants after session 3; and SST participants after session 6. The 6-week duration of the window was identical across groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Anterior knee pain or retro-patellar pain caused by at least two of the following activities: prolonged sitting with knee flexion, bilateral squatting, ascending and descending stairs, kneeling, running, and jumping;
- •(2) presence of one of the following signs: patellar tenderness, friction pain, or twitching pain, positive single-leg squat test, or positive knee extension resistance test;
- •(3) knee pain lasting more than 3 months;
- •(4) knee pain score greater than 3 out of 10 on the VAS;
- •(5) unilateral pain and symptoms.
排除标准
- •(1) acute injury of the knee ligaments, joint capsule, bursa or meniscus;
- •(2) knee extension or flexion contracture deformity, thus being unable to perform normal lower limb flexion and extension;
- •(3) patellofemoral joint dislocation or subluxation;
- •(4) any traumatic, inflammatory or infectious disease of the lower limbs;
- •(5) a history of knee surgery;
- •(6) a history of cardiovascular and cerebrovascular diseases, diabetes, tumors;
- •(7) spinal cord or neurological injury.
研究组 & 干预措施
one session of face-to-face telerehabilitation tutorial (OST)
Participants were assigned to receive either one session of face-to-face telerehabilitation tutorial (OST) and complete an 8-week home digital health program consisting of sensor-guided exercise therapy and knee pain self-care education. The primary outcome was short-term adherence as assessed by the Exercise Adherence Rating Scale (EARS) after 6 weeks of face-to-face therapy. Secondary measures included pain intensity, quadriceps strength, Kujala patellofemoral score, fatigue severity scale, and qualitative interviews affecting adherence.
干预措施: one session of face-to-face telerehabilitation tutorial (OST) (Device)
Three session of face-to-face telerehabilitation tutorials (TST)
Participants were assigned to receive 3 in-person remote rehabilitation coaching (TST) sessions and complete an 8-week home digital health program consisting of sensor-guided exercise therapy and knee pain self-care education. The primary outcome was short-term adherence as assessed by the Exercise Adherence Rating Scale (EARS) after 6 weeks of face-to-face therapy. Secondary measures included pain intensity, quadriceps strength, Kujala patellofemoral score, fatigue severity scale, and qualitative interviews affecting adherence.
干预措施: Three session of face-to-face telerehabilitation tutorials (TST) (Device)
Six session of face-to-face telerehabilitation tutorials (SST)
Participants were assigned to receive 6 in-person remote rehabilitation coaching (SST) sessions and complete an 8-week home digital health program consisting of sensor-guided exercise therapy and knee pain self-care education. The primary outcome was short-term adherence as assessed by the Exercise Adherence Rating Scale (EARS) after 6 weeks of face-to-face therapy. Secondary measures included pain intensity, quadriceps strength, Kujala patellofemoral score, fatigue severity scale, and qualitative interviews affecting adherence.
干预措施: Six session of face-to-face telerehabilitation tutorials (SST) (Device)
结局指标
主要结局
The primary outcome was device-recorded training adherence
时间窗: Six weeks after completion of face-to-face rehabilitation instruction
The primary outcome was device-recorded training adherence, defined as cumulative total training time (hours) and mean weekly training time (hours/week) over the first 6 weeks of independent home-based telerehabilitation. Data recording commenced immediately after each participant completed his or her final face-to-face tutorial, thereby isolating adherence to the unsupervised home program. Because the three groups differed in the number of tutorials received, the calendar start date of the 6-week recording window varied: OST participants began the recording window after session 1; TST participants after session 3; and SST participants after session 6. The 6-week duration of the window was identical across groups.
次要结局
- pain intensity(Complete the entire 8-week rehabilitation process)
- Self-reported adherence was measured using the Exercise Adherence Rating Scale(Six weeks after completion of face-to-face rehabilitation instruction)
- quadriceps strength(Complete the entire 8-week rehabilitation process)
- Kujala scores(Complete the entire 8-week rehabilitation process)
- Fatigue severity scale(Complete the entire 8-week rehabilitation process)
- adherence survey(Complete the entire 8-week rehabilitation process)