Clinical trial NCT07010640: A Comparison of Video Versus Written Instructions for Early Motion Flexors Rehabilitation
Official title: A Comparison of Video Versus Written Instructions for Early Motion Flexors Rehabilitation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Compliance, Treatment
Hand Flexor Repair
Compliance to Rehabilitation After Hand Flexor Repair
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group of participants will receive written instructions following hand flexor repair, whilst the other group will receive video instructions in addition to written on instructions.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

To protect patient confidentiality, data will be stored in an encrypted database in the orthopedic surgery department at the University of Puerto Rico (UPR) Medical Sciences Campus. Only study personnel will have access to the room and computer where digital files will be stored. The information will be coded with identification numbers, and the data will be stored using only these numbers. The information that will be obtained from this study will be used for the purpose specified in the protocol, and the identity of the patients will not be traced after coding. The study will be approved by the proposed research performance site Institutional Review Board (IRB) prior to the initiation of the study. No subjects will be identified by name, social security number, or any other HIPAA identifier in any reports. Any incident regarding information security and/or privacy will be reported in accordance with University Hospital/Medical Sciences Campus policy and procedures in place for reporting incidents, i.e. theft or loss of data or storage media, unauthorized access of sensitive data or storage devices or non-compliance with security controls.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Functional outcomes
timeFrame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
measure: Patient-reported outcomes
timeFrame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
measure: Compliance with Rehabilitation Protocol
timeFrame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
measure: Functional Outcome
timeFrame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
measure: Patient Reported Outcomes
timeFrame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
measure: Patient Reported Outcomes
timeFrame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
measure: Patient Reported Outcomes
timeFrame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
measure: Patient Reported Outcomes
timeFrame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
measure: Compliance with Rehabilitation Protocol
timeFrame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
measure: Compliance with Rehabilitation Protocol
timeFrame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
Secondary outcomes:
measure: Clinical outcomes
timeFrame: 3 months after surgery
measure: Rehabilitation efficiency
timeFrame: 3 months after surgery
measure: Cognitive outcome
timeFrame: 3 months after surgery
measure: Clinical Outcomes
timeFrame: 3 months after surgery
measure: Cognitive Outcome
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: Orthopaedic Surgery Clinic at ASEM
city: San Juan
country: Puerto Rico
facility: Puerto Rico Level 1 Trauma Hospital
Study officials:
affiliation: Orthopaedic Surgery Department, School of Medicine
name: Christian Foy, M.D.
role: PRINCIPAL_INVESTIGATOR
References: