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

NCT06651996 | Completed DMC

• 1 other identifier: M2023699
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Patellofemoral Pain

Keywords

mHealth; Telerehabilitation; Patellofemoral pain; Exercise adherence; Wearable sensors; Tutorial dose.

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (6)

• 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

Study Arms (3)

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

SHAM COMPARATOR

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.

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

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

Interventions

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.

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

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.

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

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.

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital Medicial Science Research Ethics Committee

Beijing, China

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: October 22, 2024
• Study Start: January 1, 2025
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: May 28, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)