Adherence and Feasibility of Remote Rehabilitation for Chronic Patellofemoral Joint Pain: a Randomized Controlled Trial

NCT ID: NCT06651996

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-10
• Study Completion Date: 2024-10-30

Brief Summary

This study is a prospective, single-center trial involving 66 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 measure was exercise adherence assessed using the Exercise Rating Scale (EARS) after 6 weeks of rehabilitation. Secondary outcomes included knee pain severity, muscle strength, knee function, fatigue levels, and a qualitative research questionnaire. An isokinetic strength testing system was used to measure the open-chain strength of the quadriceps muscle.

Detailed Description

The inestigators conducted a forward-looking, single-center pilot study with a follow-up period of 8 weeks. The study recruited 66 patients diagnosed with patellofemoral pain (PFP) by a professional sports physician at the Department of Sports Medicine, Peking University Third Hospital, between January and September 2023. 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 Outcome The primary outcome was assessed by the Exercise Adherence Rating Scale (EARS) 6 weeks after completing the rehabilitation guidance. The scale consists of Part A, which directly assesses adherence (including 6 questions, each with 5 options, scoring from 0 to 4), and Part B, which assesses reasons affecting adherence (including 10 questions, each with 5 options, scoring from 0 to 4). Items with positive phrasing were reverse scored, so a higher overall adherence score indicates better exercise adherence.

Secondary Outcomes Secondary outcomes were collected at the hospital 8 weeks after the start of the study, including knee pain severity assessed by the Visual Analog Scale (VAS) (ranging from 0 "no pain" to 10 "worst pain"); isokinetic concentric and eccentric peak torque of the quadriceps muscle reflecting knee joint muscle strength; Kujala Patellofemoral Score (0 to 100 points, with higher scores indicating better knee function); and the Fatigue Severity Scale (FSS), which measures the severity of fatigue in patients with various conditions and its impact on activities and lifestyle (including 9 questions, each scored from 1 to 7, with higher scores indicating greater fatigue). Additionally, after completing the remote rehabilitation program, the inestigators conducted a qualitative research questionnaire to explore potential strategies to improve adherence.

Conditions

Patellofemoral Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

one session of face-to-face telerehabilitation tutorial (OST)

Intervention Type: DEVICE

The first group participated in a face-to-face tele-rehabilitation session in the hospital on the use of sensors and rehabilitation software before the home-rehabilitation session. Thereafter, the tele-rehabilitation program included muscle strengthening, flexibility stretching, and movement quality training every Tuesday, Thursday, and Saturday.

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.

Group Type: EXPERIMENTAL

Three session of face-to-face telerehabilitation tutorials (TST)

Intervention Type: DEVICE

The second group participated in three face-to-face tele-rehabilitation sessions in the hospital on the use of sensors and rehabilitation software before the home-rehabilitation session. Thereafter, the tele-rehabilitation program included muscle strengthening, flexibility stretching, and movement quality training every Tuesday, Thursday, and Saturday.

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.

Group Type: EXPERIMENTAL

Six session of face-to-face telerehabilitation tutorials (SST)

Intervention Type: DEVICE

The third group participated in six face-to-face tele-rehabilitation sessions in the hospital on the use of sensors and rehabilitation software before the home-rehabilitation session. Thereafter, the tele-rehabilitation program included muscle strengthening, flexibility stretching, and movement quality training every Tuesday, Thursday, and Saturday.

Interventions

one session of face-to-face telerehabilitation tutorial (OST)

The first group participated in a face-to-face tele-rehabilitation session in the hospital on the use of sensors and rehabilitation software before the home-rehabilitation session. Thereafter, the tele-rehabilitation program included muscle strengthening, flexibility stretching, and movement quality training every Tuesday, Thursday, and Saturday.

Intervention Type: DEVICE

Three session of face-to-face telerehabilitation tutorials (TST)

The second group participated in three face-to-face tele-rehabilitation sessions in the hospital on the use of sensors and rehabilitation software before the home-rehabilitation session. Thereafter, the tele-rehabilitation program included muscle strengthening, flexibility stretching, and movement quality training every Tuesday, Thursday, and Saturday.

Intervention Type: DEVICE

Six session of face-to-face telerehabilitation tutorials (SST)

The third group participated in six face-to-face tele-rehabilitation sessions in the hospital on the use of sensors and rehabilitation software before the home-rehabilitation session. Thereafter, the tele-rehabilitation program included muscle strengthening, flexibility stretching, and movement quality training every Tuesday, Thursday, and Saturday.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• (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.

Exclusion Criteria

• (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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University Third Hospital Medicial Science Research Ethics Committee

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

ZHENG ZHOU, M.D

Role: CONTACT

zhouzheng1914@163.com

13253137009

Jianquan Wang, M.D

Role: CONTACT

wjqsportsmed@163.com

13253137009

Facility Contacts

wangjianquan wang

Role: primary

wjqsportsmed@163.com

13801076267

Other Identifiers

M2023699

Identifier Type: -

Identifier Source: org_study_id