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临床试验/NCT07010640
NCT07010640尚未招募不适用

A Comparison of Video Versus Written Instructions for Early Motion Flexors Rehabilitation

University of Puerto Rico4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
4
主要终点
Functional outcomes

研究概览

简要总结

The research objective is to evaluate the efficacy of video instructions compared to written or verbal instructions for early motion rehabilitation following hand flexor repair. The primary research question addresses whether video instructions improve compliance with early motion rehabilitation post-surgery compared to traditional methods. The hypothesis is that patients who receive video instructions are more likely to adhere to their rehabilitation regimen than those who receive verbal or written instructions.

详细描述

Flexor tendon injuries are prevalent, particularly among the working-age population, leading to significant disability and financial burden, with annual costs ranging from $240 to $409 million in the United States. Effective rehabilitation is crucial to prevent complications like stiffness and adhesions. Advances in surgical techniques, such as multi-strand core sutures, have enabled early active rehabilitation. Previous studies indicate the benefits of video-assisted therapy and education in various medical contexts, suggesting that video instructions could similarly enhance compliance and outcomes in hand flexor rehabilitation. The study aims to assess the efficacy of video instructions versus written or verbal instructions for early motion rehabilitation following hand flexor repair.

The study consists of a single-center single-blinded randomized control trial comparing the communication methods of instructions for early motion rehabilitation following hand flexor repairs. All procedures will be performed under Wide-Awake Local Anesthesia No Tourniquet (WALANT). The sample size will consist of 60 participants. The subjects will be randomly assigned (1:1 randomization) to one of two groups; the experimental group will receive video instructions, while the control group written and verbal instructions. Both groups will be surgically managed by two board-certified orthopaedic hand surgeons (i.e., Christian Foy, MD & Eric Astacio, MD) at a supra-tertiary local hospital (i.e., Oncologic Hospital) under the same operative approach (i.e., six-strand flexor repair). All the subjects will receive the standard of care including a dorsal blocking splint and follow-up visits in hand clinic.

Data collection methods include: surveys, questionnaires (i.e., three - patient satisfaction, pain levels, and self-efficacy), clinical assessments (i.e., ROM, grip strength and complication rates), and communication with the therapist to assess exercise adherence and frequency.

The statistical analysis plan for this study involves summarizing the baseline characteristics of the study population and primary/secondary outcomes using descriptive statistics. Chi-square will be used to compare bivariate categorical variables while t-test will be used to analyze continuous non-parametric variables. A multivariate analysis will be used to control for potential confounder and assess the independent effect of the instruction method on outcomes. A 95% confidence interval with an alpha of 0.05 will be considered statistically significant. Microsoft Excel and STATA software will be used for statistical analysis.

A waiver from the IRB will be requested to gain authorization for the release of health information. All patient records will be kept under use for the duration of the study. The estimated duration of this study is 1 year.

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
Single (Participant)

盲法说明

Participants will be informed that they are taking part in a study, but no distinction will be made between written and video instructions. Participants receiving written instructions will not be made aware of the alternative video instructions. Similarly, participants receiving video instructions will not be made aware that they are part of the experimental group and that the other group is not receiving video instructions.

入排标准

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

入选标准

  • Patients 18 years old or older Isolated flexor injuries Procedures performed under WALANT technique Providing written informed consent

排除标准

  • Patients younger than 18 years old Patients with other injuries Procedures performed under any anesthesia other than WALANT Mental disability History of psychiatric disorders

结局指标

主要结局

Functional outcomes

时间窗: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.

Range of motion (i.e., using a goniometer)

Patient-reported outcomes

时间窗: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.

Visual Analog Scale (VAS) Measuring distance from 1-100 millimeters. Higher scores indicate pain, whilst lower scores indicate less or no pain.

Functional Outcome

时间窗: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.

Grip strength (i.e., using a dynamometer)

Compliance with Rehabilitation Protocol

时间窗: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.

Frequency of the early motion exercises (i.e., track how often the patients perform their rehabilitation exercises)

Patient Reported Outcomes

时间窗: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.

Numeric Rating Scale (NRS) A ten point scale, with 0 representing no pain and 10 representing the worst possible pain.

次要结局

  • Clinical outcomes(3 months after surgery)
  • Rehabilitation efficiency(3 months after surgery)
  • Cognitive outcome(3 months after surgery)
  • Clinical Outcomes(3 months after surgery)
  • Cognitive Outcome(3 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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