Home-based Rehabilitation With A Novel Digital Biofeedback System Versus Conventional Rehabilitation After Total Knee Replacement: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Change in the Timed up And Go Test score
研究概览
简要总结
The study was designed to test patient acceptance and system usability and to assess clinical outcomes of a home-based rehabilitation program using a novel kinematic biofeedback system in the rehabilitation after total knee replacement versus conventional rehabilitation, This system allows the patients to perform independent rehabilitation sessions at home, under remote monitoring from the clinical team.
The investigators hypothesize that the system will be well received by patients and that the clinical outcomes will be at least similar those of conventional rehabilitation.
This is a quasi-randomized controlled trial with active comparator. Patients will be enrolled pre-operatively and divided into 2 groups: experimental group and conventional rehabilitation group according to geographical criteria. Both groups will perform 8 weeks of rehabilitation starting between day 7 and 10 after surgery.
The experimental group will perform daily rehabilitation sessions at home using the system, under remote monitoring from a physical therapist. The conventional rehabilitation group will perform 1h rehabilitation sessions 3 times a week, at home, given by a physical therapist.
The following feasibility outcomes will be registered: enrollment rate, retention rate (drop-outs), compliance to the program, independence of use, need for therapist contact and patient satisfaction.
Clinical outcomes will be measured at weeks 4 and 8 and then at 3 and 6 months. The primary outcome will be measured in terms of patient performance in the Timed-up-and-Go (TUG) test in comparison with the pre-operative score. Secondary outcomes will be measured in terms of: b) Knee Osteoarthritis Outcome Score); c) range of motion of the knee joint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
All patients will be assessed for clinical outcomes by an independent rater blinded to the study arm
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
- •Patients over 18 years old
- •Clinical and imaging evidence of knee osteoarthritis
- •Indication for total knee replacement according to the patient´s orthopedic surgeon
- •Ability to walk unaided, with unilateral or bilateral support
- •Availability of a carer to assist the patient after surgery
排除标准
- •Patients admitted for revision of total knee replacement
- •Contralateral hip or knee osteoarthritis severely limiting patient mobility and ability to comply with a rehabilitation program
- •Aphasia, dementia or psychiatric comorbidity interfering with the communication or compliance to the rehabilitation process
- •Respiratory, cardiac, metabolic or other condition incompatible with at least 30 minutes of light to moderate physical activity
- •Major medical complications occurring after surgery that prevent the discharge of the patient within 10 days after the surgery
- •Other medical and/or surgical complications that prevent the patient from complying with a rehabilitation program
- •Blind and/or illiterate patients
研究组 & 干预措施
Experimental group
Home-based rehabilitation sessions performed with the novel digital biofeedback system.
Patients will be instructed to perform exercise sessions in at least 5 days per week, but compliance to this schedule is not mandatory per protocol.
干预措施: Home-based rehabilitation with a digital biofeedback system (Device)
Conventional rehabilitation group
Home-based rehabilitation sessions provided by a Physical Therapist, 3 times a week for 8 weeks. Each session will have a duration of 60 minutes. Patients will be instructed to perform additional unsupervised sessions in at least two other days, but compliance to these extra sessions is not mandatory per protocol.
干预措施: Conventional Home-based rehabilitation (Other)
结局指标
主要结局
Change in the Timed up And Go Test score
时间窗: Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery
The timed up and go requires a patient to rise from a chair walk three meters around a piece of tape and return to the chair again as quickly as possible.
次要结局
- Change in Knee injury and Osteoarthritis Outcome Score (KOOS)(Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery)
- Change in Knee Range of Motion (degrees)(Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery)