Tele-rehabilitation After Anterior Cruciate Ligament Reconstruction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorKexin Wang, MM
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
With synthetic tendon reconstruction;
Concomitant meniscus lesion which needs operation;
Concomitant other ligaments injury which needs operation;
Concomitant intra-articular knee fracture;
Trial design
Design model
Parallel
Treatments tested in this trial
Tele-rehabilitation
BehavioralThe 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.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
the percentage of patients who achieve a satisfactory active ROM (flexion and extension)
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.
Time frame
at the 2, 4, 8, 12 and 24 weeks following the ACLRSecondary outcomes
1
active and passive ROM
The active and passive ROM of the affected side knee
Time frame
at the 2, 4, 8, 12 and 24 weeks following the ACLR2
Visual analogue scale (VAS)
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.
Time frame
at the 2, 4, 8, 12 and 24 weeks following the ACLR3
Muscle strength
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
Time frame
at the 2, 4, 8, 12 and 24 weeks following the ACLR4
The 2000 International Knee Documentation Committee (IKDC)
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.
Time frame
at the 2, 4, 8, 12 and 24 weeks following the ACLRLocations
Sponsors and contacts
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Kexin Wang, MM
Lead sponsor
West China Hospital
Sponsor institution
Source ClinicalTrials.gov
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