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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06327555
Enrollment
164
Registered
2024-03-25
Start date
2024-03-30
Completion date
2025-07-30
Last updated
2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

ACLR, Telerehabilitation

Brief summary

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.

Detailed description

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.

Interventions

OTHERtelerehabilitation

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.

OTHERin-person rehabilitation

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.

Sponsors

Peking Union Medical College Hospital
CollaboratorOTHER
Peking University First Hospital
CollaboratorOTHER
Peking University Third Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Lysholm scoreFrom 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

MeasureTime frameDescription
Peak torque and symmetry of knee flexors and extensorsFrom before ACLR surgery to 6 months after surgery.Used to assess knee muscle strength
IKDC scoreFrom 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.
Tegner scoreFrom 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.
VAS scoreFrom 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.
Short Form-36 Health Survey(SF-36)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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026