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NCT Number: NCT06232824

Tele-rehabilitation After Anterior Cruciate Ligament Reconstruction

The investigators aims to evaluate the effect of multicomponent supervised tele-rehabilitation, compared to home-based self-rehabilitation, on range of motion (ROM), pain, muscle strength, and function in patients following ACLR. The hypothesis is of superiority for the effects of multicomponent supervised tele-rehabilitation over home-based self-rehabilitation.

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Key information

Conditions

Tele-rehabilitation Anterior Cruciate Ligament Reconstruction

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged between 18 and 50 years at the time of recruit;
  • BMI between 16 and 28 kg/m²;
  • acute unilateral ACL rupture;
  • plan for an ACLR surgery (with autologous hamstrings tendon reconstruction) under arthroscopy;
  • ACL rupture to ACLR within 3 months;
  • Patients can independently use mobile software and WeChat mini programs, and can operate related software through the "Huajiantong" mini program under the guidance of staff;

Exclusion criteria

  • With synthetic tendon reconstruction;
  • Concomitant meniscus lesion which needs operation;
  • Concomitant other ligaments injury which needs operation;
  • Concomitant intra-articular knee fracture;
  • Concomitant fracture or injury which may affect postoperative exercise;
  • Previous history of knee infection, fracture, and surgery;
  • Participate in knee exercises and/or rehabilitation programs in the past three months;
  • Living outside the city, regular return to the hospital for follow-up cannot be guaranteed;
  • Serious cardiopulmonary disease and unable to participate in rehabilitation exercise;
  • Other reasons for exclusion (mental disorders, stroke, pregnancy, etc).

Treatment and study plan

Tele-rehabilitation

Behavioral

The whole program is constituted of preoperative education and postoperative rehabilitation (in hospital and out of hospital). All the participants received the same preoperative education through the mobile phone application and oral communication. Participants in the intervention group get the multicomponent supervised tele-rehabilitation, while participants in the control group get the home-based self-rehabilitation. All the postoperative rehabilitation programs are presented and executed through the mobile phone application.

Primary outcomes

  1. the percentage of patients who achieve a satisfactory active ROM (flexion and extension)

    Time frame: at the 2, 4, 8, 12 and 24 weeks following the ACLR

    In the first 3 months after ACLR, the achievement of acceptable knee active extension and flexion was regarded as what matters most for a successful recovery. A good knee active ROM could guarantee an expectedly continue improvement.

Secondary outcomes

  1. active and passive ROM

    Time frame: at the 2, 4, 8, 12 and 24 weeks following the ACLR

    The active and passive ROM of the affected side knee

  2. Visual analogue scale (VAS)

    Time frame: at the 2, 4, 8, 12 and 24 weeks following the ACLR

    The postoperative pain was measured with VAS. The VAS scale ranges from 0 to 10 points, 0 points represent no pain, while 10 points represent the worst imaginable pain. A higher VAS score mean a worse outcome.

  3. Muscle strength

    Time frame: at the 2, 4, 8, 12 and 24 weeks following the ACLR

    The isokinetic concentric strength test was used to assess muscle strength. Isokinetic concentric extenso was the best rated with sufficient intrarater reliability and construct validity for the measurement of knee muscle strength

  4. The 2000 International Knee Documentation Committee (IKDC)

    Time frame: at the 2, 4, 8, 12 and 24 weeks following the ACLR

    The 2000 International Knee Documentation Committee (IKDC) Subjective Knee Form is a patient-oriented questionnaire that assesses symptoms and function in daily living activities. Scores are obtained by summing the individual items and then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.

  5. knee injury and osteoarthritis outcome score (KOOS)

    Time frame: at the 2, 4, 8, 12 and 24 weeks following the ACLR

    The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL).Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.

  6. the Tegner activity scale

    Time frame: at the 2, 4, 8, 12 and 24 weeks following the ACLR

    the Tegner activity scale is a one-item questionnaire that is scored on an 11-item scale (0 to 10) based on the patient's reported level of activity/work. A level of 0 represents maximum disability while a level of 10 represents elite sports athletes.

  7. the Lysholm knee scoring scale

    Time frame: at the 2, 4, 8, 12 and 24 weeks following the ACLR

    The Lysholm Knee Score is a questionnaire consisting of 8 items that the patient completes together with the therapist. The questionnaire is designed to assess the degree of knee instability at both impairment and limitation levels. .The Lysholm Knee Score calculates and grades an overall score from 0 to 100 based on 8 domains: squatting, locking, pain, stair climbing, support, instability, and edema.A higher score mean a better outcome. Scores between 95 and 100 are regarded as exceptional, 84 and 94 as acceptable, 65 to 83 as fair, and less than 65 as poor.

Study contacts

Contact information is provided by the study sponsor or research team.

Kexin Wang, MM

CONTACT

[email protected]

+86 15881189695

Sponsors and collaborators

Lead sponsor

Kexin Wang, MM

Other

Registry information

Official study title

Multicomponent Supervised Tele-rehabilitation Versus Home-based Self-rehabilitation After Anterior Cruciate Ligament Reconstruction

Acronym: tele-rehab

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 31, 2024
Registry last updated
Jan 31, 2024

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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