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Completed

NCT Number: NCT06327555

Comparison of the Efficacy of Telerehabilitation and In-person Rehabilitation Based on Wearable Devices After ACLR Surgery: a Multicenter Randomized Controlled Trial

Purpose: Investigate whether telerehabilitation based on wearable devices is clinically as effective as in-person rehabilitation for ACLR patients.

Subjects: 164 patients aged ≥18 years who underwent ACLR. Design: A mixed-block randomization method was used to randomly assign participants to two groups: the telerehabilitation group and the in-person rehabilitation group, with a 50% probability of assignment to each group. All participants received standard postoperative rehabilitation training with identical content. The telerehabilitation group received postoperative telerehabilitation guidance via software and sensors. The in-person rehabilitation group received therapist-administered treatment with three rehabilitation sessions per week. All participants underwent regular follow-ups (1 day preoperatively, 3 months postoperatively, and 6 months postoperatively).

Primary outcome measure: The primary outcome measure was the Lysholm score. Secondary outcome measures included the IKDC score, Tegner Activity Scale, SF-36 questionnaire, VAS score, and isokinetic muscle strength of the knee joint.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

quan Jian Wang

Beijing, Beijing Municipality, 100191, China

About this study

Purpose: Investigate whether telerehabilitation based on wearable devices is clinically as effective as in-person rehabilitation for ACLR patients.

Subjects: Participants: This study recruited 164 participants (aged ≥18 years) undergoing ACLRsurgery;

Inclusion criteria

(1) Age range 18-60 years; (2) First-time unilateral ACLR surgery or ACLR combined with meniscus resection surgery; (3) No other lower limb joint injuries at the same time; (4) Possession of an internet-connected mobile device capable of using a mobile application; (5) Alert and oriented, with no communication impairments; Exclusion Criteria: (1) Patients undergoing revision surgery; (2) Patients who have previously undergone other lower limb surgeries; (3) Patients scheduled for another lower limb surgery within the next 6 months; (4) Patients with concomitant knee ligament injuries or severe structural damage beyond meniscal tears; (5) Patients with other comorbidities that may interfere with rehabilitation exercises; (6) Patients undergoing acute-phase surgery; (7)Patients undergoing acute surgery.

Protocol: Participants were randomly assigned to two groups using a mixed-block randomization method: the telerehabilitation group and the in-person rehabilitation group. The allocation probability for both groups was 50%. All participants received routine outpatient diagnosis and treatment. Postoperative rehabilitation training used a standardized postoperative rehabilitation training protocol with identical content. The telerehabilitation group received postoperative telerehabilitation guidance via software and sensors. The in-person rehabilitation group received three face-to-face rehabilitation sessions per week. All participants underwent regular follow-ups (1 day preoperatively, 3 months postoperatively, and 6 months postoperatively).

Primary outcome measure: The primary outcome measure was the Lysholm score. Secondary outcome measures included the IKDC score, Tegner Activity Scale, SF-36 questionnaire, VAS score, isokinetic muscle strength of the knee joint, and muscle strength symmetry.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(1) Age range 18-60 years; (2) First-time unilateral ACLR surgery or ACLR combined with meniscus resection surgery; (3) No other lower limb joint injuries at the same time; (4) Possession of an internet-connected mobile device capable of using a mobile application; (5) Alert and oriented, with no communication impairments;

Exclusion criteria

(1) Patients undergoing revision surgery; (2) Patients who have previously undergone other lower limb surgeries; (3) Patients scheduled for another lower limb surgery within the next 6 months; (4) Patients with concomitant knee ligament injuries or severe structural damage beyond meniscal tears; (5) Patients with other comorbidities that may interfere with rehabilitation exercises; (6) Patients undergoing acute-phase surgery; (7)Patients undergoing acute surgery.

Treatment and study plan

telerehabilitation

Other

The telerehabilitation group uses smart wearables and mobile apps worn around the knee joint to perform telerehabilitation at home. Both sets of training sessions are identical.

in-person rehabilitation

Other

The in-person rehabilitation group uses a face-to-face approach, with therapists providing outpatient rehabilitation guidance to patients three times a week for six weeks. After that, patients exercise at home according to the rehabilitation manual.

Primary outcomes

  1. Lysholm score

    Time frame: From before ACLR surgery to 6 months post-surgery.

    Used to assess knee joint function, with a score range of 0-100, where a higher score indicates better knee joint function.

Secondary outcomes

  1. IKDC score

    Time frame: From before ACLR surgery to 6 months post-surgery.

    Used to assess knee joint function, with a score range of 0-100. The higher the score, the better the knee joint function.

  2. Tegner score

    Time frame: From before ACLR surgery to 6 months post-surgery.

    Used to assess motor function. The range is 0-10, with higher scores indicating better knee function.

  3. VAS score

    Time frame: From before ACLR surgery to 6 months after surgery.

    Used to assess pain levels. The range is 0-10, with higher scores indicating higher pain levels.

  4. Short Form-36 Health Survey(SF-36)

    Time frame: From before ACLR surgery to 6 months post-surgery.

    Used to assess quality of life. There are 9 subscales, each with a score range of 0-100, with higher scores indicating better knee function.

  5. Peak torque and symmetry of knee flexors and extensors

    Time frame: From before ACLR surgery to 6 months after surgery.

    Used to assess knee muscle strength

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

  • Peking Union Medical College Hospital
  • Peking University First Hospital

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 25, 2024
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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