Compliance, TreatmentNCT07010640
A Comparison of Video Versus Written Instructions for Early Motion Flexors Rehabilitation
A study testing Video Instrctions in people with Compliance, Treatment and Hand Flexor Repair, run by University of Puerto Rico at 2 sites in Puerto Rico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Compliance, Treatment, Hand Flexor Repair, Compliance to Rehabilitation After Hand Flexor Repair
- What is being tested?
- Video Instrctions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesPuerto Rico
- Study dates
- Aug 2025to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18 years old or older Isolated flexor injuries Procedures performed under WALANT technique Providing written informed consent
Who cannot join
- Patients younger than 18 years old Patients with other injuries Procedures performed under any anesthesia other than WALANT Mental disability History of psychiatric disorders
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Puerto Rico2 sites
Orthopaedic Surgery Clinic at ASEM
San Juan, PR, 00936
Jose I Acosta, M.D., 787-379-4119, jose.acosta14@upr.edu
Jose Rodriguez, M.D., (787)-447-9319, jose.rodriguez44@upr.edu
Puerto Rico Level 1 Trauma Hospital
San Juan, PR, 00936
Jose I Acosta, M.D., 787-379-4119, jose.acosta14@upr.edu
Jose Rodriguez, M.D., (787)-447-9319, jose.rodriguez44@upr.edu
About this study
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.
Read the 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.
- Conditions
- Compliance, Treatment, Hand Flexor Repair, Compliance to Rehabilitation After Hand Flexor Repair
- Being tested
- Video Instrctions
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video InstrctionsOther
Video instructions of rehabilitation techniques and movements to help with adherence and compliance to treatment.
| Study group | Role | What they receive |
|---|---|---|
| Video Instructions Group | Experimental | In addition to written instructions, will receive video instructions to facilitate rehabilitation process. Receives: Other: Video Instrctions |
| Written Instructions Group | No intervention | Will only receive written instructions for rehabilitation process. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcomes
Range of motion (i.e., using a goniometer)
Measured: 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.
Measured: 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)
Measured: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
Functional Outcome
Grip strength (i.e., using a dynamometer)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
Secondary outcomes (5)
Clinical outcomes
Complication rates: track the incidence of adhesions, re-ruptures, and infections.
Measured: 3 months after surgery
Rehabilitation efficiency
Number of follow-up visits: compare the number of follow-up visits required for each group.
Measured: 3 months after surgery
Cognitive outcome
Instruction comprehension: assess the understanding of the instructions through a quiz or verbal feedback.
Measured: 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.
Measured: 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.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study startAug 2025 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compliance, TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Foy, M.D., Principal investigator, Orthopaedic Surgery Department, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010640
- Sponsor's protocol ID
- 240624458
- Status last verified
- May 2025
- First submitted
- 19 Feb 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Video Versus Written Instructions for Early Motion Flexors Rehabilitation
- ClinicalTrials.gov ID
- NCT07010640
- Acronym / sponsor ID
- 240624458
- Conditions
- Compliance, Treatment, Hand Flexor Repair, Compliance to Rehabilitation After Hand Flexor Repair
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Video Instructions Group | Experimental | Other: Video InstrctionsIn addition to written instructions, will receive video instructions to facilitate rehabilitation process. |
| Written Instructions Group | No intervention | –Will only receive written instructions for rehabilitation process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18 years old or older Isolated flexor injuries Procedures performed under WALANT technique Providing written informed consent
Key exclusion criteria (1 listed)
- Patients younger than 18 years old Patients with other injuries Procedures performed under any anesthesia other than WALANT Mental disability History of psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video InstrctionsVideo instructions of rehabilitation techniques and movements to help with adherence and compliance to treatment. | Other | Video Instructions Group |
Primary outcome
Functional outcomes
Time frame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
Range of motion (i.e., using a goniometer)
Patient-reported outcomes
Time frame: 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.
Compliance with Rehabilitation Protocol
Time frame: 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)
Functional Outcome
Time frame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
Grip strength (i.e., using a dynamometer)
Patient Reported Outcomes
Time frame: 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.
Patient Reported Outcomes
Time frame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
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.
Patient Reported Outcomes
Time frame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
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.
Patient Reported Outcomes
Time frame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
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)
Compliance with Rehabilitation Protocol
Time frame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
Adherence to physical therapy (i.e., via self-reports or therapist assessments)
Compliance with Rehabilitation Protocol
Time frame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.
Duration of the early motion exercises (i.e., track for how long the patients perform their rehabilitation exercises)
5 secondary outcomes
Clinical outcomes
Time frame: 3 months after surgery
Rehabilitation efficiency
Time frame: 3 months after surgery
Cognitive outcome
Time frame: 3 months after surgery
Clinical Outcomes
Time frame: 3 months after surgery
Cognitive Outcome
Time frame: 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian Foy, M.D. principal investigator
Orthopaedic Surgery Department, School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Instrctions in people with Compliance, Treatment and Hand Flexor Repair, run by University of Puerto Rico at 2 sites in Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose I Acosta, M.D. (787-379-4119, jose.acosta14@upr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcomes (time frame: The measurement is assessed at 2 weeks, 6 weeks, and 3 months.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.