Effectiveness of Exercise Relative Motion Orthoses for Improving Limited Proximal Phalangeal Joint Motion: A Single-Center, Single-Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Finger range of motion
研究概览
简要总结
This randomized controlled trial investigates the effectiveness of two exercise orthosis designs-the Relative Motion Flexion (RMF) and Relative Motion Extension (RME) orthoses-for improving motion in patients with proximal interphalangeal joint (PIPJ) flexion or extension deficits. A total of 148 adult patients with acute hand injuries and a minimum 10° difference between active and passive PIP joint motion will be enrolled. Participants are stratified by their primary motion deficit and randomized to either the exercise orthosis or placebo orthosis group. The orthosis is worn for 4 weeks, with follow-up assessments at weeks 6 and 8 to evaluate range of motion and patient satisfaction. All participants will continue standard hand therapy throughout the study.
详细描述
The prevention and treatment of proximal interphalangeal joint (PIPJ) contractures are key goals in hand rehabilitation, often addressed with orthotic interventions. The choice of orthosis design depends on the severity and timing of the injury or disease. During the acute stage, static splinting is typically used, while more dynamic orthoses, such as static-progressive splinting, are recommended in the chronic stages to manage contractures. If a contracture already exists, hand therapists differentiate between dynamic and fixed deformities in PIPJ flexion or extension. Fixed deformities do not or hardly respond to passive mobilisation, while dynamic deformities show a difference in active and passive range of PIPJ motion - e.g. in cases of soft tissue adhesions hindering active motion.
In addition to traditional passive orthoses, which stretch the PIPJ in a fixed position during dedicated periods, exercise-based orthoses (relative motion orthoses, RM) have been developed to enhance PIPJ mobility during everyday activities. These include Relative Motion Extension (RME) and Relative Motion Flexion (RMF) orthoses, designed to improve both flexion and extension. Studies have shown that RME orthoses improve active flexion, while RMF orthoses aid in active extension, with patients reporting high satisfaction and functional benefits from using these devices in daily tasks. Furthermore, RM orthoses have been widely adopted by therapists, demonstrating benefits in improving functional hand use and promoting non-intentional exercise.
Since the use of relative motion (RM) orthoses - especially as exercise orthoses - is relatively new, few prospective studies have examined their effectiveness in improving PIPJ motion. Therefore, this study aims to compare the effectiveness of exercise RM orthoses with a placebo orthosis to identify the most beneficial treatment strategies for patients with limited PIPJ motion. The goal is to strengthen the evidence base and refining the clinical application of exercise-based orthotic interventions.
The primary objective of this study is to compare the effectiveness of two orthoses designs, the exercise RME and RMF orthosis vs. a placebo orthosis.
Secondary objectives are:
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
- Double (Participant, Investigator)
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
- •PIPJ motion deficit with a minimum difference of 10° between passive and active motion
- •To have an acute injury, i.e. operated on or within maximum 6 weeks of accident
- •Only one hand is affected
- •Adult patients over 18 years of age
- •Understanding German, French or English
- •Hand therapy treatment in-house at Inselspital in Bern
- •Ability to give informed consent as documented by signature
排除标准
- •Previous injuries to the hand or PIPJ (e.g., intra-articular fractures, PIPJ ligament damage) that may limit baseline joint mobility and influence responsiveness to the intervention.
- •Presence of conditions such as osteoarthritis (OA) or rheumatoid arthritis (RA) that may affect PIPJ stiffness, pain, or inflammation.
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia
- •Boutonniere deformity
- •Minors (below 18 years of age)
研究组 & 干预措施
PIP extension deficit treated with a placebo RMF orthosis
The orthosis is worn for 4 weeks. At week 6 and 8, follow-up visits are planned to measure PIPJ range of motion and patient satisfaction. For all arms, standard hand therapy treatment continues as needed.
干预措施: PIP extension deficit treated with a placebo RMF orthosis (Device)
PIP extension deficit treated with an exercise RMF orthosis
The orthosis is worn for 4 weeks. At week 6 and 8, follow-up visits are planned to measure PIPJ range of motion and patient satisfaction. For all arms, standard hand therapy treatment continues as needed.
干预措施: PIP extension deficit treated with an exercise RMF orthosis (Device)
PIP flexion deficits treated with an exercise RME orthosis
The orthosis is worn for 4 weeks. At week 6 and 8, follow-up visits are planned to measure PIPJ range of motion and patient satisfaction. For all arms, standard hand therapy treatment continues as needed.
干预措施: PIP flexion deficits treated with an exercise RME orthosis (Device)
PIP flexion deficits treated with a placebo RMF orthosis
The orthosis is worn for 4 weeks. At week 6 and 8, follow-up visits are planned to measure PIPJ range of motion and patient satisfaction. For all arms, standard hand therapy treatment continues as needed
干预措施: PIP flexion deficits treated with a placebo RMF orthosis (Device)
结局指标
主要结局
Finger range of motion
时间窗: Change from baseline to 2, 4 and 6 weeks
PIPJ active and passive motion will be measured using a hand-held goniometer. The goniometer is placed dorsal to the joint in all cases with the arms of the goniometer aligned on the finger bones. The DIP, the PIP and MCP joints will be measured in both extension and flexion range of motion. The degrees of measurement will be noted using the neutral-zero method.
次要结局
- Patient satisfaction(Change from baseline to 2, 4 and 8 weeks)
- Patient Specific Functional Scale (PSFS)(Change from baseline to 4 and 8 weeks)
- Orthosis diary(continuous)
研究者
Bernadette Tobler
Head of hand therapy research unit
Insel Gruppe AG, University Hospital Bern