Feasibility and Effectiveness of Telerehabilitation for Anterior Cruciate Ligament Reconstruction - TAR Program Involving a Motion Capture Mobile Application in Adolescents: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Exercise adherence
研究概览
简要总结
Anterior cruciate ligament (ACL) injuries are common in adolescents and its prevalence has increased over the years, especially with more adolescents engaging in physical activities and competitive sports. Standard of care for these injuries would be an ACL reconstruction (ACLR) to allow return to function and sports and reduce the risk of post-traumatic arthritis and recurrent knee injuries. Rehabilitation post-ACLR is crucial to optimise surgical outcomes and prevent re-rupture of ACL. However, good compliance to rehabilitation is often a challenge for patients and healthcare providers.
Telerehabilitation for this group of patients may help to augment rehabilitation by improving patient compliance and overcome barriers to behavioural change often observed in traditional in-person physiotherapy. It can also allow remote monitoring and provide feedback to patients during exercises. In addition, it is a useful tool during pandemic when in-person visits are not possible. Currently, very few studies have evaluated the use of telerehabilitation with remote monitoring for ACLR, especially in adolescents. The use of home-based telerehabilitation post ACLR may be key to improving patient motivation and exercise compliance in adolescents.
For this pilot study, the intervention group will undergo the TAR program in addition to standard care, which involves self-administered exercises in initial 12 weeks post ACLR using a mobile application. The mobile application will detect key landmarks on the body for human pose estimation. Participants will be able to perform their exercises with real-time feedback given, allowing for proper execution of the exercises. Exercise adherence, range of motion and pain scores will be tracked via the application and therapists are able to monitor via the online dashboard. The control group will undergo standard in-person physiotherapy.
Primary aim of this study is to examine exercise adherence in TAR program versus standard care post ACLR in adolescents. Secondary aims of this study are to examine the effects of TAR program on knee strength, range, function, quality of life, treatment satisfaction, self-determination and number of face-to-face rehabilitation sessions required after ACLR.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants age 12 to 20 years old
- •Participants undergoing ACLR surgery
- •Participants willing to be included in either the intervention group (utilizing the mobile application) or control group
排除标准
- •Participants with complications after ACLR surgery
- •Participants with significant neurological or other lower limb impairments or conditions affecting mobility and function
- •Participants with previous ACL surgeries of the same affected lower limb
- •Participants with previous surgeries or trauma to the unaffected lower limb
结局指标
主要结局
Exercise adherence
时间窗: Post-operatively: Week 3, Week 6, Week 9, Week 12
This will be measured via the Exercise Adherence Rating Scale (via the 6 item questions on assessing adherence to prescribed home exercises) over 12 weeks post-operatively, via changes in scores over the time points. The scores will range from 0-24, with higher scores indicating higher adherence.
次要结局
- Range of motion(Pre-operatively (≤one month prior to operation), Post-operatively: Week 3, Week 6, Week 9, Week 12)
- Self-reported quality of life(Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12)
- Treatment satisfaction(Post-operatively: Week 6, Week 12)
- Number of face to face rehabilitation session(Post-operatively: Week 12)
- Quadriceps and hamstring strength(Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12)
- Motivation(Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12)
- mHealth App Usability Questionnaire (MAUQ)(Post-operatively: Week 12)
- One leg sit to stand(Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12)
- Pain intensity(Pre-operatively (≤one month prior to operation), Post-operatively: Week 3, Week 6, Week 9, Week 12)
- Self-reported function(Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12)
- Perceived competence(Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12)
研究者
Siao Hui Toh
Principal Investigator
KK Women's and Children's Hospital