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Patellofemoral PainNCT06651996

Mobile-Based Telerehabilitation With Sensors for Adherence and Efficacy in Chronic Patellofemoral Pain: A Randomized Controlled Trial

A study testing one session of face-to-face telerehabilitation tutorial (OST), Three session of face-to-face telerehabilitation tutorials (TST) and Six session of face-to-face telerehabilitation tutorials (SST) in people with Patellofemoral Pain, run by Peking University Third Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Patellofemoral Pain
What is being tested?
one session of face-to-face telerehabilitation tutorial (OST), Three session of face-to-face telerehabilitation tutorials (TST) and Six session of face-to-face telerehabilitation tutorials (SST)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
174 participants
Where
1 siteChina
Study dates
1 Jan 2025to 31 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • (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.

Who cannot join

  • (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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Peking University Third Hospital Medicial Science Research Ethics Committee

    Beijing

Other trials in China

About this study

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

Read the detailed description

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.

Secondary Outcomes. 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). The EARS comprises Section A (6 items assessing adherence to prescribed home exercise) and Section B (10 items exploring barriers to adherence). Items are rated on a 5-point Likert scale (0 = "strongly disagree" to 4 = "strongly agree"), with positively phrased items reverse scored such that higher scores indicate better adherence. The EARS has demonstrated good reliability (Cronbach α = .85) and construct validity. (Multimedia Appendix 3). Secondary engagement metrics, including frequency of question-and-answer visits and number of reminder alerts generated by the system, were recorded over the 6-week period and explored as surrogate indicators of self-management behavior but were not included in the primary adherence endpoint. Additional secondary outcomes were assessed at the 8-week endpoint: pain 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

Being tested
one session of face-to-face telerehabilitation tutorial (OST), Three session of face-to-face telerehabilitation tutorials (TST), Six session of face-to-face telerehabilitation tutorials (SST)
Keywords
mHealth; Telerehabilitation; Patellofemoral pain; Exercise adherence; Wearable sensors; Tutorial dose.
Medical subject headings
Patellofemoral Pain Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06651996
Study groupRoleWhat they receive
one session of face-to-face telerehabilitation tutorial (OST)Sham comparatorParticipants 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.
Receives: Device: one session of face-to-face telerehabilitation tutorial (OST)
Three session of face-to-face telerehabilitation tutorials (TST)ExperimentalParticipants 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.
Receives: Device: Three session of face-to-face telerehabilitation tutorials (TST)
Six session of face-to-face telerehabilitation tutorials (SST)ExperimentalParticipants 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.
Receives: Device: Six session of face-to-face telerehabilitation tutorials (SST)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary outcome was device-recorded training adherence

    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.

    Measured: Six weeks after completion of face-to-face rehabilitation instruction

Secondary outcomes (6)
  1. pain intensity

    Secondary outcome measures were collected at the hospital 8 weeks after the start of the study, including the severity of knee pain during daily living and squatting at 60 degrees (from 0 "no pain" to 10 "most severe") assessed on the visual analogue scale (VAS);

    Measured: Complete the entire 8-week rehabilitation process

  2. Self-reported adherence was measured using the Exercise Adherence Rating Scale

    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). The EARS comprises Section A (6 items assessing adherence to prescribed home exercise) and Section B (10 items exploring barriers to adherence). Items are rated on a 5-point Likert scale (0 = "strongly disagree" to 4 = "strongly agree"), with positively phrased items reverse scored such that higher scores indicate better adherence. The EARS has demonstrated good reliability (Cronbach α = .85) and construct validity.

    Measured: Six weeks after completion of face-to-face rehabilitation instruction

  3. quadriceps strength

    Isokinetic quadriceps femoris concentric and eccentric peak torque reflect muscle strength around the knee joint.The open-chain muscle strength of the quadriceps muscle was tested with an isokinetic muscle strength testing system (Contrex MJ) in two modes: 60°/s centripetal contraction and 60°/s centrifugal contraction. The range of the test was from 90° to 20° of knee flexion. During the test, the subjects were asked to relax as much as possible before the test, with the trunk flexed at an angle of 120°, so that the test could be performed under the reduced influence of gravity. Each contraction mode was repeated 5 times, and the interval between adjacent contraction modes was 3 minutes to rest the thigh muscles.

    Measured: Complete the entire 8-week rehabilitation process

  4. Kujala scores

    Kujala patellofemoral score is used to evaluate the function of the knee joint (0-100, with higher scores indicating better knee function)

    Measured: Complete the entire 8-week rehabilitation process

  5. Fatigue severity scale

    Fatigue severity scale (FSS) is used to measure the fatigue degree of patients with various diseases and its impact on people's activities and lifestyle (9 questions in total, 7 points for each question, the higher the score, the greater the fatigue degree)

    Measured: Complete the entire 8-week rehabilitation process

  6. adherence survey

    Furthermore, the adherence survey collected structured responses through closed-ended questions on factors influencing telerehabilitation adherence. Response frequencies were calculated for each item

    Measured: Complete the entire 8-week rehabilitation process

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2024
  2. Study start1 Jan 2025
  3. Primary completion31 May 2025
  4. Study completion31 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06651996
Sponsor's protocol ID
M2023699
Status last verified
May 2025
First submitted
19 Sep 2024
Last updated
28 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing one session of face-to-face telerehabilitation tutorial (OST), Three session of face-to-face telerehabilitation tutorials (TST) and Six session of face-to-face telerehabilitation tutorials (SST) in people with Patellofemoral Pain, run by Peking University Third Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome was device-recorded training adherence (time frame: Six weeks after completion of face-to-face rehabilitation instruction). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

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