Multicomponent Supervised Tele-rehabilitation Versus Home-based Self-rehabilitation After Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 主要终点
- the percentage of patients who achieve a satisfactory active ROM (flexion and extension)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Blinded participants and therapists were not implemented in our study. Before the intervention, an independent researcher communicated with the patient to inform the method of using the mobile application. Apart from the mobile application, no paper rehabilitation program materials will be distributed to participants. Admission, ACLR surgery, follow-up, and assessment of all participants were conducted separately and will not be arranged in the same ward room to avoid discussion and communication between participants. The ACLR surgery was performed by a senior surgeon who was blinded to the group allocation. In addition, we selected two assessors who were blinded to the group allocation to measure the baseline data and follow-up outcomes after the intervention. The collection and analysis of data were carried out by two independent researchers who were also blinded to the group allocation.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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).
研究组 & 干预措施
Intervention
Participants in the intervention group coud only view the rehabilitation content that needs to be carried out at the current phase every day and confirm whether to execute it on the application. Participants could communicate with therapists on the mobile phone application by sending text, voice, images, and videos throughout the entire experiment.
Participants in the intervention group received detailed education and rehabilitation program on the mobile phone application including text, photos, and videos. On the first day of enrollment, the doctor inform the participants of the importance of rehabilitation and how to use the mobile phone application. The postoperative rehabilitation protocol includes four phases: Phase 1 (0-2 weeks), Phase 2 (3-4 weeks), Phase 3 (5-8 weeks), Phase 4 (9-12 weeks), and Phase 5 (after 13 weeks).
干预措施: Tele-rehabilitation (Behavioral)
Control
Participants in the control group could only receive a graphic and textual minimal postoperative rehabilitation plan on the mobile phone application. However, the participants was not informed the frequency and intensity of the rehabilitation items. They could not communicate with therapists online. Participants in the control group was expected to exercise unsupervised postoperatively.
At the 2, 4, 8, 12, and 24 weeks after ACLR, all participants went to the outpatient clinic for follow-up by physiotherapist to provide face-to-face guidance for exercise methods. Physiotherapist would clarify the content of the rehabilitation plan if any doubt, but will not provide information extending the prearranged scope.
结局指标
主要结局
the percentage of patients who achieve a satisfactory active ROM (flexion and extension)
时间窗: 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.
次要结局
- the Lysholm knee scoring scale(at the 2, 4, 8, 12 and 24 weeks following the ACLR)
- active and passive ROM(at the 2, 4, 8, 12 and 24 weeks following the ACLR)
- Muscle strength(at the 2, 4, 8, 12 and 24 weeks following the ACLR)
- the Tegner activity scale(at the 2, 4, 8, 12 and 24 weeks following the ACLR)
- Visual analogue scale (VAS)(at the 2, 4, 8, 12 and 24 weeks following the ACLR)
- The 2000 International Knee Documentation Committee (IKDC)(at the 2, 4, 8, 12 and 24 weeks following the ACLR)
- knee injury and osteoarthritis outcome score (KOOS)(at the 2, 4, 8, 12 and 24 weeks following the ACLR)
研究者
Kexin Wang, MM
Clinical Professor
West China Hospital