Efficacy of Real-time Feedback Exercise Therapy in Patients Following Total Hip Arthroplasty: a Pilot Cluster-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Frontal knee angle range of motion Pelvic obliquity angle range of motion Frontal trunk angle range of motion
研究概览
简要总结
This pilot cluster-randomized, two-arm parallel-group controlled trial, aims at enhancing the understanding of the effects of real-time feedback on functional deficits as knee valgus thrust, pelvic drop, and lateral trunk lean after total hip arthroplasty. Biomechanical and patient-reported outcomes will be assessed after a total hip arthroplasty as well as at three and six months follow-ups. The primary research question is, whether digital real-time feedback supported home-exercising improves the control of the frontal knee range of motion, pelvic obliquity, and lateral trunk lean, superior to exercising supported by written instructions as comparator. The secondary aspect focuses on potential differences between groups concerning aspects of quality of life, function, and physical activity. Tertiary functional outcomes between groups will be compared for reasons of quantification movement quality.
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
- None
盲法说明
Participants will be randomly assigned to IG or CG after baseline assessment. Due to the nature of the studied conditions, it will not be possible to blind researchers or participants.
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age from 50-75 years
- •body mass index from 18.5 to 29.99 kg/m²
- •able to walk without walking aids at baseline assessment
- •scheduled for elective unilateral total hip arthroplasty surgery
- •willing to comply with all study related procedures and provide informed consent
排除标准
- •symptoms of delayed healing concerning the implant
- •cardio-respiratory symptoms limiting exercise therapy (for example severe heart disease)
- •symptoms of musculoskeletal or cardio-respiratory overload
- •neuro-motor diseases (for example previous Stroke, Multiple Sclerosis, Morbus Parkinson Disease)
- •other reasons which would lead to obvious limitations concerning their participation in the intervention (for example severe contralateral osteoarthritis (OA), lower extremity fractures within previous 12 months, other elective lower extremity surgery within 6 months, inadequacy in German concerning questionnaires and exercise instructions, mentally unable to participate)
- •non-adherence (see definition under "therapeutic adherence").
结局指标
主要结局
Frontal knee angle range of motion Pelvic obliquity angle range of motion Frontal trunk angle range of motion
时间窗: Baseline 4 weeks post-surgery; 3-months post-surgery; 6-months post-surgery
Above listed angles derived from assessed Activities of Daily Living (ADL) tasks
次要结局
- Harris Hip Score (HHS) Hip Osteoarthritis Outcome Score (HOOS) Short-Form-Health Survey (SF12) International Physical Activity Questionnaire - short form (IPAQ) if applicable: Knee Injury and Osteoarthritis Outcome Score (KOOS)(Baseline 4 weeks post-surgery; 3-months post-surgery; 6-months post-surgery)
研究者
Klaus Widhalm
Head of study
FH Campus Wien, University of Applied Sciences