Home-based Rehabilitation With A Digital Biofeedback System Versus Conventional Rehabilitation After Total Hip Replacement: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 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 compare the clinical outcomes of a home-based rehabilitation program using a novel digital biofeedback system against conventional home-based rehabilitation after total hip replacement This system allows the patients to perform independent rehabilitation sessions at home, under remote monitoring from the clinical team. The investigators hypothesise that the clinical outcomes of a home-based rehabilitation program will be at least similar to the outcomes of a traditional home-based rehabilitation with face-to-face sessions. This is a single-center, prospective, parallel-group pilot study with active comparator. Patients will be enrolled pre-operatively and then divided into 2 groups: experimental group and conventional rehabilitation group. Both groups will perform an 8-week rehabilitation program starting between day 7 and 10 after surgery.
The experimental group will perform daily exercise sessions at home using the system, under remote monitoring from a physical therapist. The conventional rehabilitation group will perform 3 home-based rehabilitation sessions per week, each with 1h duration, given by a physical therapist.
Outcomes will be measured at weeks 4 and 8 and then at 3 and 6 months. The primary outcome is the change in patient performance measured by the Timed-up-and-Go (TUG) test between in comparison with the pre-operative score. Secondary outcomes will be measured in terms of: a) Hip Osteoarthritis Outcome Score (HOOS); b) range of motion of the hip joint (lying flexion/abduction; standing flexion/adbuction/hyperextension)
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 hip osteoarthritis
- •Indication for total hip 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 hip 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 7 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 digital biofeedback system. Patients will be instructed to perform exercise sessions at least 5 days a week, but compliance to this schedule is not mandatory.
干预措施: Digital biofeedback system (Device)
Conventional rehabilitation group
Home-based rehabilitation sessions provided by a Physical Therapist, 3 times a week, each with 1h duration. Patients will be instructed to perform 2 additional unsupervised sessions per week, but compliance to these sessions is not mandatory.
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 Hip 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 the Range of Motion (degrees)(Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery)