The Effect of Virtual Reality Based Task Specific Exercises in Patients With Hand Flexor Tendon Injury

January 8, 2024 updated by: Mert Karacay, Ankara City Hospital Bilkent

Evaluation of the Effect of Virtual Reality Based Task Specific Exercises on Functional Level and Disease Related Quality of Life in Patients With Hand Flexor Tendon Injury

This study,the investigators aimed to investigate the effects of virtual reality-based task-specific exercises applied in addition to conventional rehabilitation program on functional level and disease-related quality of life in patients who underwent surgical repair due to flexor tendon damage due to traumatic hand injury.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06800
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Tendon repair operation due to flexor tendon injury in one hand
  • Admission to the Traumatic Hand Rehabilitation Outpatient Clinic of Ankara City Hospital Physical Medicine and Rehabilitation Hospital within the first postoperative week and enrolled in an early passive mobilization program
  • Must be in the sixth post operative week

Exclusion Criteria:

  • Under 18 years of age
  • Concomitant extensor tendon injury
  • Having any accompanying orthopedic, neurologic, rheumatologic and vascular problems in the premorbid period
  • Presence of cognitive deficit
  • Presence of visual field deficit
  • Presence of postural instability
  • Presence of epilepsy and/or cyber disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Virtual Reality Intervention Group
Consisted of patients who received a virtual reality-based task-specific exercise programme in addition to the early passive mobilisation programme
Other: Virtual Reality Exercises
In addition to conventional treatment, patients in the study group underwent a virtual reality-based task-specific exercise program in a computer-based virtual reality station. Two different virtual reality games that fit the definition of task-specific exercise were selected for our study. In order for the patient to complete the task in the game, the patient was asked to extend the upper extremity and hand to touch the virtual object through the reflection on the screen and to first grasp the object in the virtual environment by making active flexion with all fingers and to move it from one place to another on a certain plane without disturbing the grasping posture of the hand. These virtual reality exercises selected in our study were practiced under the supervision of the researcher 3 days a week for 15 minutes each for a total of 4 weeks. These sessions consisted of three sets of 2.5 minutes each for each game, with 15-second breaks between sets.
No Intervention: Control Group
Consisted of patients who received the early passive mobilisation programme

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in short form-36 (SF-36) scores
Time Frame: Pre-intervention (postoperative sixth week), immediately after the intervention (postoperative tenth week)
A scale used for determining quality of life. This form evaluates the quality of life under 9 different headings. Minimum value of all headings is %0 and maximum is %100. Higher scores mean a better outcome.
Pre-intervention (postoperative sixth week), immediately after the intervention (postoperative tenth week)
The functional level of dexterity and coordination
Time Frame: Pre-intervention (postoperative sixth week), immediately after the intervention (postoperative tenth week)
The functional level of dexterity and coordination was assessed with the Nine-Hole Peg Test. The test material for this test consists of nine standardised pegs and a board with nine holes equidistant from each other. When the patient feels ready, the patient is asked to close the nine holes as quickly as possible, regardless of the order of the sticks, provided that the patient places one stick at a time. Once all the holes have been filled, without a break, the patient is asked to remove the rods one by one from the holes and put them back where they came from. From the moment the patient touches the first stick, the observer starts timing. When the last rod is removed and placed in the area where the rods were taken, the time is stopped and recorded. In measurements made in different periods in the same patient, completion of the test in a shorter time indicates improvement in hand skills.
Pre-intervention (postoperative sixth week), immediately after the intervention (postoperative tenth week)
Dexterity-related activity limitations in activities of daily living
Time Frame: Pre-intervention (postoperative sixth week), immediately after the intervention (postoperative tenth week)
Dexterity-related activity limitations in activities of daily living were assessed by Duruöz hand index and Quick Disability of Arm, Shoulder and Hand. Duruöz hand index includes 18 questions on manual dexterity related to "kitchen work, dressing, personal hygiene, office work and other activities of daily living". The questionnaire takes approximately 2-3 minutes to complete. The minimum score that can be obtained from the questionnaire is 0 points while the maximum score is 90 points. A lower score indicates fewer limitations in activities of daily living. The Quick Arm, Shoulder and Hand Disability Scale consists of 11 questions. Minimum value of the scale is 0 and maximum is 100. Higher scores mean a worse outcome.
Pre-intervention (postoperative sixth week), immediately after the intervention (postoperative tenth week)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Grip strength
Time Frame: Pre-intervention (postoperative sixth week), immediately after the intervention (postoperative tenth week)
The grip strength was measured with a Jamar dynamometer. The measured value was recorded in kilograms.
Pre-intervention (postoperative sixth week), immediately after the intervention (postoperative tenth week)
Change in active range of motion
Time Frame: Pre-intervention (postoperative sixth week), immediately after the intervention (postoperative tenth week)
Range of motion was measured using a standard hand goniometer and the measured degree was recorded.
Pre-intervention (postoperative sixth week), immediately after the intervention (postoperative tenth week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 263799996/75

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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