米尔·沙基尔远程整合治疗方案与传统物理疗法对全膝关节置换术患者疼痛、关节活动度、步态、功能结局及生活质量的影响 (RCT)
米尔·沙基尔远程整合疗法方案与传统物理疗法对全膝关节置换术患者疼痛、活动范围、步态、功能结果及生活质量的影响
本临床试验旨在评估新建立的远程康复治疗方案与传统物理疗法在全膝关节置换术后患者康复中的效果对比。
本研究主要探索以下问题:
远程康复在改善疼痛、关节活动度和步态方面是否与传统物理疗法同样有效?
远程康复是否能提高运动依从性、减少运动恐惧症,并改善生活质量和患者满意度?
结合两种方法的混合康复方案是否能优化临床和功能结局?
研究人员将比较基于远程康复的物理疗法与传统面对面疗法,以确定哪种方法在TKA术后康复中效果更优。
参与者需满足:
为50-65岁接受初次全膝关节置换术的成年患者
在规定的干预期内接受传统物理治疗或基于远程康复的锻炼计划
参加定期随访评估,测量疼痛、关节活动度、步态、功能表现和满意度
完成关于生活质量、运动恐惧症和运动依从性的验证问卷
研究意义
骨关节炎在巴基斯坦日益成为健康关切,患病率从1990年的285万上升至2021年的849万。 TKA手术数量的增加催生了对可及、经济且循证的康复模式的需求。 远程康复通过将专业护理延伸至患者家中,提升可及性并确保治疗连续性,提供了创新解决方案。
本研究将提供本地化相关证据,可能促成巴基斯坦患者标准化康复方案的制定——改善康复结局,减轻医疗负担,并提升术后生活质量。
最终,本研究致力于加强巴基斯坦循证康复实践,减轻术后残疾负担,并提升膝关节置换术康复患者的生命质量。
研究概览
详细说明
This study is a two-arm, parallel-group randomized clinical trial designed to compare the clinical effectiveness of a Modified Structured Telerehabilitation Intervention Protocol (MSTITP) with conventional in-person physical therapy in patients following Total Knee Arthroplasty (TKA). The study also investigates whether a digitally supported rehabilitation model can serve as an effective or superior alternative to traditional physiotherapy care.
Participants will be recruited from post-operative TKA patients who meet eligibility criteria and provide informed consent. Eligible participants will be adults aged 50-65 years who have undergone primary unilateral TKA and are medically stable for rehabilitation. Participants with neurological disorders, revision surgeries, or contraindications to exercise will be excluded.
Following enrollment, participants will be randomly allocated into two equal groups:
Group A - Telerehabilitation (MSTITP)
Participants will receive a structured, progressive rehabilitation program delivered remotely via telecommunication platforms. The intervention will include:
Supervised exercise sessions conducted through video-based guidance Home-based progressive strengthening exercises Range of motion training protocols Gait re-education strategies Functional task-oriented exercises Regular remote monitoring and feedback from a physiotherapist
The protocol is designed to enhance accessibility, improve adherence, and ensure continuity of care in a home-based environment while maintaining clinical oversight.
Group B - Conventional Physiotherapy
Participants will receive standard postoperative rehabilitation through direct, face-to-face sessions in a clinical setting. Treatment will include:
Therapist-supervised exercise therapy Manual guidance for ROM improvement Strengthening exercises Gait training Functional mobility training Both groups will receive rehabilitation over an equal intervention duration to ensure comparability.
Outcome Measures
Participants in both groups will be assessed at predefined follow-up intervals using validated outcome measures.
Primary Outcomes:
Pain intensity (Visual Analog Scale - VAS) Knee Range of Motion (goniometric measurement) Gait performance and functional ambulation
Secondary Outcomes:
Functional performance (standardized functional tests) Exercise adherence levels Kinesiophobia (fear of movement) Health-related quality of life Patient satisfaction with treatment
Data will be analyzed using appropriate statistical methods to compare within-group and between-group differences over time. Intention-to-treat analysis will be considered to handle dropouts and maintain methodological rigor.
Rationale and Clinical Importance
Osteoarthritis is a major and increasing public health concern in Pakistan, contributing to a rising number of total knee arthroplasty procedures. This has created a significant demand for effective, accessible, and cost-efficient postoperative rehabilitation strategies.
Telerehabilitation represents an emerging model that may overcome barriers such as geographic limitations, limited physiotherapy access, financial burden, and poor adherence to clinic-based rehabilitation. By enabling structured rehabilitation in home settings with professional supervision, it has the potential to improve continuity of care and functional recovery.
This trial is expected to generate context-specific evidence regarding the effectiveness of telerehabilitation in a Pakistani healthcare setting and may contribute to the development of standardized postoperative rehabilitation guidelines for TKA patients. The findings may also support integration of hybrid rehabilitation models into routine clinical physiotherapy practice, ultimately improving functional outcomes and reducing healthcare system burden.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Dr. Mir Shakeel Ahmad
- 电话号码:00923224268894
- 邮箱:mirshakeel.phdscholar@lincoln.edu.my
研究联系人备份
- 姓名:Dr. Salwa Atta
- 电话号码:00923084579229
- 邮箱:salwa.atta@ubas.edu.pk
学习地点
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Punjab Province
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Lahore、Punjab Province、巴基斯坦
- 招聘中
- Ghurki Trust and Teaching Hospital
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接触:
- Dr. Mir Shakeel Ahmad
- 电话号码:00923224268894
- 邮箱:mir.ahmad@ghurkitrust.org.pk
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接触:
- Prof. Dr. Naeem Ahmad
- 邮箱:naeem.ahmad@ghurkitrust.org.pk
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
纳入标准:
- 因骨关节炎接受初次单侧全膝关节置换术的患者
- 能够参与远程康复或现场康复计划,并在有或无辅助设备(如拐杖、助行器)的情况下表现出足够的活动能力,符合全膝关节置换术后治疗要求
- 参与者必须可靠拥有可连接互联网的智能手机、平板电脑或计算机,并具备进行视频通话的能力
- 愿意并能够提供知情同意,并遵守所有研究方案,包括预定的治疗课程和随访评估
排除标准:
- 存在可能干扰安全参与康复的重大合并症或并发症,如严重心血管疾病,或导致严重行动不便的病症(例如其他关节的严重骨关节炎或类风湿关节炎)
- 曾接受过同侧膝关节置换或其他重大膝关节手术,这可能影响康复结果的标准化
- 当前正在参加其他物理治疗或康复试验,或在研究方案之外进行额外康复治疗
- 存在认知障碍或严重视力、听力损伤,以致无法遵循治疗指导或使用远程康复技术
- 研究者认为可能妨碍遵守研究程序或使参与者承受不当风险的任何其他状况或因素
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:MSTITP 组
该组患者将根据其方便时间,由物理治疗师亲自进行诊疗并通过远程康复模式进行治疗。
所提供的治疗方案是一种基于个性化运动的治疗规程,该规程已在相同环境下通过对80名患者的试点测试得到验证。
本规程是在Ghurki信托教学医院骨科专家医生的监督下制定的。
该规程为接受全膝关节置换术的患者制定了基于周度的运动计划。
每项运动的频率和时长根据患者的年龄、病情严重程度及手术时长进行设定。
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该干预方案包含从住院部术后开始直至第23周的每周锻炼计划。
计划从手术后24小时内开始,持续至术后12周。
包括系列锻炼项目:第1周计划包含患者教育、床上活动、体位转移、踝泵运动、足跟滑动、直腿抬高、仰卧髋外展和内收、股四头肌等长收缩及坐位膝关节屈曲。
第2-4周包含冷疗、踝泵运动、股四头肌等长收缩、足跟滑动、迷你深蹲、站立提踵、坐位膝关节屈伸、原地踏步及台阶踏步训练。
第4-6周包含台阶踏步、直线行走、三维直腿抬高、坐站转换、单腿平衡、迷你深蹲、弓步蹲、站立提踵、助行器辅助行进及站立提趾训练。
第6-12周包含单腿平衡、步态训练、单腿站立躯干旋转、巴苏球训练、侧向行走及深蹲训练。
整个方案根据需求辅以经颅磁刺激治疗。
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有源比较器:常规物理治疗
本组患者将接受传统物理治疗,所有疗程均需在医院/诊所内面对面进行。
实验组患者提供的所有锻炼方案和规程,B组患者也将进行练习,但不会将锻炼模式转为远程康复,以排除远程康复可能产生的任何影响。
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The Group B shall receive the same exercise plan in in - person treatment sessions 2-3 times per week.
The set of exercises and frequency incorporated match with the one being provided to patients in group CPT.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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关节活动度
大体时间:第1周-第12周
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关节活动度应通过测角仪进行测量
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第1周-第12周
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患者疼痛通过数字疼痛评分量表评估
大体时间:第1周 - 第12周
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该量表由1到10的评分组成,其中1表示最小疼痛,10表示最大疼痛。
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第1周 - 第12周
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Quality of Life as assessed by Short Form Health Survey -36
大体时间:WEEK 1-WEEK 12
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Short Form 36 evaluates patient functions in 8 domains including physical functions, role limitations, body pain, health perceptions, vitality, social functions, role limitations and mental health.
Higher schores reflect more functional impairements and lesser scores show less impairements.
Each item is evaluated on a scale of 0-100.
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WEEK 1-WEEK 12
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Functional outcomes as assessed by Western Ontario and McMaster Universities Osteoarthritis Index
大体时间:Week 1- Week 12
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The Western Ontario and McMaster University Osteoarthritis Index is composed of 24 questions and scores from 0 to 96 where 0 reflects best health status
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Week 1- Week 12
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Gait as assessed through Jack's Observatory Gait Analysis
大体时间:WEEK 1 - WEEK 12
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Gait analysis shall be done through Jacks' Observatory Gait Analysis.
Temporal Parameters like Step length, Stride length, Cadence and Symmetry will be assessed.
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WEEK 1 - WEEK 12
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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通过运动依从性评定量表评估的运动依从性
大体时间:第 1 周 - 第 12 周
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运动依从性评定量表将用于测量运动依从性,评分范围为0-24分。
分数越高表示运动依从性越好。
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第 1 周 - 第 12 周
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Patient Satisfaction as assessed through Patient Satisfaction Questionnaire
大体时间:WEEK 1- WEEK 12
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Patient Satisfaction shall be evaluated through Patient Satisfaction Questionnaire -18 and it contains 18 items.
Each item is scored from 1 to 5 and maximum score is 90 with 90 reflecting the best satisfaction levels of patients.
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WEEK 1- WEEK 12
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合作者和调查者
调查人员
- 首席研究员:Dr. Mir Shakeel Ahmad、Lincoln College University
- 首席研究员:Prof Dr. Chua Siew Kuan、Lincoln College University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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