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

NCT07010640 | Not Yet Recruiting

• 1 other identifier: 240624458
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Compliance, Treatment; Hand Flexor Repair; Compliance to Rehabilitation After Hand Flexor Repair

Outcome Measures

Primary Outcomes (10)

• Functional outcomes

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

  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.

  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)

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

• Functional Outcome

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

  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.

  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.

  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.

  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)

  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)

  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)

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

Secondary Outcomes (5)

• 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

Study Arms (2)

Video Instructions Group

EXPERIMENTAL

In addition to written instructions, will receive video instructions to facilitate rehabilitation process.

Other: Video Instrctions

Written Instructions Group

NO INTERVENTION

Will only receive written instructions for rehabilitation process.

Interventions

Video Instrctions OTHER

Video instructions of rehabilitation techniques and movements to help with adherence and compliance to treatment.

Video Instructions Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Puerto Rico: lead

Study Sites (2)

Orthopaedic Surgery Clinic at ASEM

San Juan, PR, 00936, Puerto Rico

Location

Puerto Rico Level 1 Trauma Hospital

San Juan, PR, 00936, Puerto Rico

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Christian Foy, M.D.

  Orthopaedic Surgery Department, School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose I Acosta, M.D.

CONTACT

787-379-4119; jose.acosta14@upr.edu

Jose Rdoríguez, M.D.

CONTACT

787-447-9319; jose.rodriguez44@upr.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: June 8, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PR (2)