An interventional study of Video Instrctions in Compliance, Treatment, Hand Flexor Repair and Compliance to Rehabilitation After Hand Flexor Repair, sponsored by University of Puerto Rico. Not yet recruiting at 2 sites in Puerto Rico. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-08.
Sponsored by University of Puerto Rico · Not applicable, Interventional, and Treatment
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.
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.
752 studies on the registry are indexed under Patient Compliance; 72 are open to participants now.
This study's planned enrollment of 60 is below the median of 116 across 527 interventional studies indexed under Patient Compliance.
Browse Patient Compliance studies →University of Puerto Rico is the lead sponsor of 46 studies on the registry; 15 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients 18 years old or older Isolated flexor injuries Procedures performed under WALANT technique Providing written
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In addition to written instructions, will receive video instructions to facilitate rehabilitation process.
Other: Video Instrctions
Will only receive written instructions for rehabilitation process.
Video instructions of rehabilitation techniques and movements to help with adherence and compliance to treatment.
Functional outcomes
Range of motion (i.e., using a goniometer)
Time frame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
Patient-reported outcomes
Visual Analog Scale (VAS) Measuring distance from 1-100 millimeters. Higher scores indicate pain, whilst lower scores indicate less or no pain.
Time frame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
Compliance with Rehabilitation Protocol
Frequency of the early motion exercises (i.e., track how often the patients perform their rehabilitation exercises)
Time frame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
Functional Outcome
Grip strength (i.e., using a dynamometer)
Time frame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
Patient Reported Outcomes
Numeric Rating Scale (NRS) A ten point scale, with 0 representing no pain and 10 representing the worst possible pain.
Time frame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
Patient Reported Outcomes
Disabilities of the Arm, Shoulders and Hand (DASH) A self report questionnaire, scored from 0-100. Higher scores indicate a more severe disability, lower scores indicate little or no disability.
Time frame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
Patient Reported Outcomes
Patient Rated Wrist Evaluation (PRWE) Patient rate their pain and disabilities using wrist over the last week, on a score from 0-10. Higher scores indicate a higher degree of pain and disability.
Time frame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
Patient Reported Outcomes
Satisfaction with instruction methods: utilize a standardized questionnaire to gauge patient satisfaction with the instruction method (i.e., the system usability scale or a custom satisfaction survey)
Time frame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
Compliance with Rehabilitation Protocol
Adherence to physical therapy (i.e., via self-reports or therapist assessments)
Time frame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
Compliance with Rehabilitation Protocol
Duration of the early motion exercises (i.e., track for how long the patients perform their rehabilitation exercises)
Time frame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
Clinical outcomes
Complication rates: track the incidence of adhesions, re-ruptures, and infections.
Time frame: 3 months after surgery
Rehabilitation efficiency
Number of follow-up visits: compare the number of follow-up visits required for each group.
Time frame: 3 months after surgery
Cognitive outcome
Instruction comprehension: assess the understanding of the instructions through a quiz or verbal feedback.
Time frame: 3 months after surgery
Clinical Outcomes
Time to return to work: measure the time taken for patients to return to their usual activities or work.
Time frame: 3 months after surgery
Cognitive Outcome
Self-efficacy: use the general Self-Efficacy Scale to measure the patient's confidence in performing their rehabilitation exercises.
Time frame: 3 months after surgery
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2025; primary completion for Jul 2026, 11 months later.
Of 224 non-industry interventional studies with no phase under Patient Compliance, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 37. This study's planned 11 months is below that.
Counting every sponsor, half of 237 studies reached it within 20 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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University of Puerto Rico