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临床试验/NCT03982719
NCT03982719Unknown不适用

Randomized Controlled Trial Comparing the Effectiveness of Two Post-fasciectomy Rehabilitation Protocols Differing in Intensity and Implementation of Modalities in Patients With Dupuytren's Disease

Véronique Flamand2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
Change from first evaluation on the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) outcome measure at 2, 3 and 6 months

研究概览

简要总结

Dupuytren's disease can cause physical impairments that lead to reduced functional performance in personal care, work-related and leisure activities. The prevalence of Dupuytren's disease increases with age. A meta-analysis completed in 2014 by Lanting and al. estimated the its prevalence in western countries at 12% among people aged 55 years and over and at 29% among individuals aged 75 and over. The fasciectomy is the most current surgical procedure to reduce the flexion contracture occurring in this disease. Studies confirm the relevance of post-operative rehabilitation after fasciectomy. This rehabilitation is usually conducted by hand therapists who are mostly occupational therapists. However, the required duration and frequency of interventions and exercises for the post-op rehabilitation are not clearly described in the literature. In fact, the guidelines that are currently available recommend a total duration between 16 and 75 hours, which is highly variable. Also, the need to include supervised exercises by the occupational therapist is not specified. The main goal of this study is to compare two post-fasciectomy rehabilitation protocols to determine the influence of protocols intensity on motor and functional outcomes in people with Dupuytren's disease. The hypothesis is that the protocol involving a higher intensity will lead to better motor and functional improvements. The secondary goal of this study is to explore the link between the total time that the person has done the recommended exercises (combination of supervised exercises and the home program) and motor/functional recovery. The hypothesis is that the relationship between the amount of time and the motor/functional improvements will not be linear, but will either be logarithmic toward a plateau of recovery.

A randomized controlled trial will be realized. 40 participants will be randomly assigned to one of the two rehabilitation protocols. Each participant will be evaluated at four times (initial evaluation, final evaluation and 2 follow-up evaluations). Data on motor and functional recovery will be collected.

详细描述

Dupuytren's disease can cause physical impairments that lead to reduced functional performance in personal care, work-related and leisure activities. The prevalence of Dupuytren's disease increases with age. A meta-analysis completed in 2014 by Lanting and al. estimated the its prevalence in western countries at 12% among people aged 55 years and over and at 29% among individuals aged 75 and over. The fasciectomy is the most current surgical procedure to reduce the flexion contracture occurring in this disease. Studies confirm the relevance of post-operative rehabilitation after fasciectomy. This rehabilitation is usually conducted by hand therapists who are mostly occupational therapists. However, the required duration and frequency of interventions and exercises for the post-op rehabilitation are not clearly described in the literature. In fact, the guidelines that are currently available recommend a total duration between 16 and 75 hours, which is highly variable. Also, the need to include supervised exercises by the occupational therapist is not specified. The main goal of this study is to compare two post-fasciectomy rehabilitation protocols to determine the influence of protocols intensity on motor and functional outcomes in people with Dupuytren's disease. The hypothesis is that the protocol involving a higher intensity will lead to better motor and functional improvements. The secondary goal of this study is to explore the link between the total time that the person has done the recommended exercises (combination of supervised exercises and the home program) and motor/functional recovery. The hypothesis is that the relationship between the amount of time and the motor/functional improvements will not be linear, but will either be logarithmic towards a plateau of recovery.

A randomized controlled trial will be realized. 40 participants will be randomly assigned to one of the two rehabilitation protocols. Each participant will be evaluated at four times (initial evaluation, final evaluation and 2 follow-up evaluations). The independent variable of this study is the intensity of the rehabilitation protocol (BRIEF or INTENSE). The primary dependent variable is the functional abilities to perform activities of daily living. The secondary dependent variables are the following : digits range of motion, pain, grip and pinch strengths, as well as tactile sensibility.

The BRIEF PROTOCOL consists of 4 intervention sessions with an occupational therapist specialized in hand therapy that will occur at 0-3 days, 2 weeks, 4 weeks and 8 weeks post-fasciectomy. The occupational therapist will give recommendations about the management of swelling, wound care and functional recovery. An home exercises program will be given to the participant. Finally, an extension splint that must be worn at night until the third month after surgery will be made at the first session. The INTENSE PROTOCOL consists of 6 intervention sessions with an occupational therapist specialized in hand therapy that will occur at 0-3 days, 2 weeks, 3 weeks, 4 weeks, 6 weeks and 8 weeks after surgery. The occupational therapist will give recommendations about the management of swelling, wound care and functional recovery. An home exercises program will be given to the participant. An extension splint that must be worn at night until the third month after surgery will be made at the first session. Also, exercises will be performed by the patient under the supervision of the occupational therapist (supervised exercises) in each session except the first one at 0-3 days after surgery.

Statistical analyses will take into account the moderate size of our sample (n=40) and the independence of the two groups. Descriptive statistics and Shapiro-Wilk test will be used to evaluate if variables follow the normal distribution. If the normal distribution is confirmed, repeated measure ANOVA will be used to compare the 2 groups. If not, Mann-Whitney test will be used (non-parametric test). Pearson correlation coefficient (parametric) or Spearman correlation coefficient (non-parametric) will be used to analyze the relationships between variables (secondary aim of the study).

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

年龄范围
55 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To present Dupuytren's contracture to one or two digits of the same hand and at an important stage of Dupuytren's Disease before the surgery (PIP contracture of 45 degrees or more)
  • Having had a fasciectomy to treat Dupuytren's Disease with per-op PIP contracture of 30 degrees or less.

排除标准

  • Recurrence of Dupuytren's Disease
  • To have or have had a complex regional pain syndrome
  • To present a health condition that could affect cognitive functions (dementia, neuro-cognitive disorders)
  • To have a diagnosis of diabetes

研究组 & 干预措施

Brief protocol

Experimental

4 intervention sessions with the occupational therapist of 30 minutes duration.

干预措施: Brief protocol (Other)

Intense Protocol

Active Comparator

6 intervention sessions with the occupational therapist of 60 minutes duration.

干预措施: Intense protocol (Other)

结局指标

主要结局

Change from first evaluation on the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) outcome measure at 2, 3 and 6 months

时间窗: 0-3 days, 2 months, 3 months and 6 months after surgery

Patient-reported questionnaire that evaluates 11 items on symptoms and functional impairments related to musculoskeletal disorders of the upper limb. (Total score between 0-100, rating scale from 1 to 5)

Change from first evaluation on the Sollerman Test at 2, 3 and 6 months

时间窗: 2 months and 6 months after surgery

A standardized hand function assessment based on seven of the eight most common hand grips that consists of 20 activities of daily living. (Total score between 0-80, rating scale 0 to 4).

Change from first evaluation on the Michigan Hand Questionnaire at 2, 3 and 6 months

时间窗: 0-3 days, 2 months, 3 months and 6 months after surgery

Patient-reported questionnaire that evaluates function and quality of life in patients with hand disorders. There are 37 items divided into 6 subscales (1)overall hand function, (2)activities of daily living, (3)pain, (4)work performance, (5)aesthetics and (6)patient's satisfaction with hand function). (Total score between 0-100, rating scale from 1 to 5)

次要结局

  • Range of motion assessed by Rolyan digital goniometer(0-3 days, 2 months, 3 months and 6 months after surgery)
  • Grip strength(2 months, 3 months and 6 months after surgery)
  • Tactile sensibility(2 months, 3 months and 6 months after surgery)
  • Pain measured using the Visual Analogue Scale(0-3 days, 2 months, 3 months and 6 months after surgery)
  • Pinch strength(2 months, 3 months and 6 months after surgery)

研究者

发起方
Véronique Flamand
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Véronique Flamand

Assistant Professor and Researcher

Laval University

研究点 (2)

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