Impact of Active Joint Movement to Increase Range of Motion in Knee Joint After Primary or Revision Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Range of Motion in knee joint
研究概览
简要总结
The goal of this clinical trail is to investigate if specific active exercises, with a certain daily frequency improves the range of motion (ROM) in the knee joint after primary- or revision total knee arthroplasty (TKA)
The main questions it aims to answer are:
- Does it make a difference to the ROM of the knee joint to do specific active exercise 2 times a day compared to 8 times a day in an 18 days period of time
- Analyze if range of motion in the knee joint after TKA has an impact on self-reported activity, pain and physical activity
Participants will be instructed by a physiotherapist to do a specific exercise to improve the flexion of the knee-joint and and other to improve the extension of the knee-joint.
One group will be instructed to do the exercises 2 times a day the other group to do the exercises 8 times a day in total of 18 days
The two groups will be compared to see if there is an effect in ROM and if the effect is significant between the groups if the intervention is done 2 times versus 8 times a day.
详细描述
There is a lack of knowledge about specific rehabilitation in relation to improving joint mobility of the knee joint, especially in terms of frequency and the active roll of the patients. The studies available describe predominantly passive joint mobilization after TKA (machine/therapist). Therefore there is a lack of knowledge about specific training methods regarding how patients can actively help increase joint mobility.
The purpose of the study is to verify whether increased frequency of two specific active joint movement exercises, for reduced flexion and/or extension, respectively, at fixed daily intervals over a continuous 18-day period can further increase joint mobility after TKA.
The hypothesis is that patients can increase joint mobility after TKA by repeating individual movement exercises with a high daily frequency.
Based on previous clinical experience at the department and data from published articles, a realistic assessment is that patients who receive intervention with a high frequency of joint movement exercises (8 times daily) will be able to achieve an increased flexion of approx. 12 degrees compared to low-frequency intervention (2 times daily), where it is estimated that flexion can be increased by 4 degrees from baseline. Thus, there will be a change between the two intervention groups of 8 degrees.
If this kind of focused movement training has an effect, it will have a major impact on the composition of postoperative 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
- Single (Outcomes Assessor)
盲法说明
Outcomes Assessor: Have no knowledge of the intervention the individual patient has received Participant, are asked to join after they meet the criteria's for inclusion, they know what intervention they get but no knowledge of the intervention in the other group Care Provider - know at the time for the first intervention right after drawing number 2 or 8
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary or revision total knee arthroplasty
- •105° or less Flexion in knee joint;
- •Last post operation date 6 weeks to 6 month
排除标准
- •Unilateral arthroplasty in knee joint
- •Other operations in knee joint than total knee arthroplasty
- •Flexion in knee joint more than 105°
- •Operation more than 6 month ago
- •Randomizing: The visitation team assesses all referrals coming from doctors (orthopedic surgeons, general practitioners, private practice specialists) and accepts those patients for admission who are within the visitation guidelines. No members of the visitation have direct patient contact in relation to the training at Montebello. Patients are accepted through the Health Platform (SP) used in the Capital Region of Denmark.
- •After visitation, secretaries will summon patients to planned knee teams on available dates. The secretaries are geographically located 3000 kilometers away from the department and have no knowledge of the research project. In chronological order, in relation to the time of visitation, patients will be summoned to a given date. As there can be a maximum of 11 patients on a given admission date, others awaiting admission will be allocated the next available date and so on.
- •Due to the department's continuous reception of patients, where up to 11 knee patients are received in the same team on a given date, randomization cannot take place at a individual level but at team-level, so that patients hospitalized on the same date do not receive two different interventions since they train together during the 3 weeks.
- •When the actual admission takes place and the patient is physically at Montebello, a joint measurement of the knee joint will be performed by the therapist (this is not part of the project group and does not instruct knee patients). Based on this joint measurement and the other inclusion criteria, relevant patients for the project will be invited to take part in the study and included with consent.
- •Whether a group of patients receives intervention with 2 repetitions or 8 is determined by a drawing by lot after joint measurement has been done. Therapists who will oversee treatment and instruction first learn whether the group should be instructed in 2 or 8 repetitions at the first group training. The same applies to the included patients.
研究组 & 干预措施
Intervention with active exercises for knee joint 8 times a day
Intervention group B does 1 active exercise to improve flexion and 1 active exercise to improve extension 8 times a day, 18 days in a row
干预措施: Exercise (Behavioral)
Intervention with active exercises for knee joint 2 times a day
Intervention group A does 1 active exercise to improve flexion and 1 active exercise to improve extension 2 times a day, 18 days in a row
干预措施: Exercise (Behavioral)
结局指标
主要结局
Range of Motion in knee joint
时间窗: Day 1(baseline) and day 18
Active flexion and extension measured with goniometer by physiotherapist (normal Range of motion (normal 0-140 degrees)
次要结局
- The Knee Injury and Osteoarthritis Outcome Score (KOOS)(Day 1(baseline) and day 18)
- Numerical Rating Scale (NRS)(Day 1(baseline) and day 18)
- 6 minutes walk test(Day 1(baseline) and day 18)
- 30 seconds stand and sit test(Day 1(baseline) and day 18)