A Comparison Between Two Intervals of Daily Total End Range Time for Treatment of Proximal Interphalangeal Joint Flexion Contracture Using an Elastic Tension Digital Neoprene Orthosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Change in the proximal interphalangeal joint extension
研究概览
简要总结
Elastic Tension Digital Neoprene Orthosis is a new device that can increase the dose of treatment of the proximal interphalangeal flexion contractures. This treatment improved the results in extension and also reducing the time to obtain it.
详细描述
Question: In fingers with proximal interphalangeal joint flexion contractures, do significant differences exist between the passive range of motion improvement achieved in joints that receive higher doses of daily total end range time compared to those that receive lower doses of daily total end range time?
Design: Randomized parallel-group trial with concealed allocation, assessor blinding and intention-to-treat
Participants: Fifty-seven fingers in fifty patients suffering a proximal interphalangeal joint flexion contracture
Intervention: The treatment consisted of an exercise program in conjunction with the use of an extension elastic tension digital neoprene orthosis to generate extension. Researchers applied two different daily total end range time doses. Group A patients used the orthosis with a dose of twenty to twenty-two hours of daily total end range time while group B patients used the elastic tension digital neoprene orthosis to achieve a daily total end range time between eleven and thirteen hours. The exercise program was the same for both groups.
Outcome measures: The researchers performed the goniometric measurements manually twice at the beginning of every session during the three-week period. The first measurement was at the patient arrival after a preconditioning and the second was after twenty minutes. This measurement at the first session was included as a Modified weeks test while at the second, third and forth session was recorded as a contraction test. Patient report of orthosis wear time and
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, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Inclusion Criteria:
- •Patients with flexion contractures of the proximal interphalangeal joint after trauma or post-surgical complications.
- •Patients with long standing flexion contractures
- •Patients with contractures greater than 45º.
排除标准
- •Patients with acute tendon injuries or fractures
- •Patients with inflammatory conditions,
- •Patients with proximal interphalangeal joint replacements,
- •Patients with Dupuytren conservative treatments
- •Patients lacking active proximal interphalangeal joint extension
结局指标
主要结局
Change in the proximal interphalangeal joint extension
时间窗: 21 days
difference in passive finger extension between the first day and the twenty first day
- Contraction Test
时间窗: 21 days
Finger reaction at release of the orthosis
- Modified Weeks Test
时间窗: fifteen minutes
Difference in finger extension at the beginning of te session and after a 15 min passive assisted extension exercise with a force of 500g
次要结局
未报告次要终点
研究者
Vicenç Punsola Izard
Physical Therapist, Certified Hand Therapist in Hand Therapy Barcelona, MSc Gimbernat Universiy , Assistant lecturer at Gimbernat University, PhD Candidate at University of Barcelona
Hand Therapy Barcelona
