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

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: Completed
• Conditions: Flexor Tendon Rupture; Tendon Injury - Hand
• Intervention / Treatment: Other: Virtual Reality Exercises

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in short form-36 (SF-36) scores	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	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	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

Outcome Measure	Measure Description	Time Frame
Grip strength	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	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

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 10, 2024

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: virtual reality; flexor tendon rehabilitation; task specific exercise
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Tendon Injuries
• Other Study ID 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