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临床试验/NCT05625451
NCT05625451已完成不适用

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

Vicenç Punsola Izard2 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2020年11月1日最近更新:
适应症

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

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

发起方
Vicenç Punsola Izard
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

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

研究点 (2)

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