NCT06198582

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

8 months

First QC Date

November 21, 2023

Last Update Submit

January 8, 2024

Conditions

Keywords

flexor tendon rehabilitationvirtual realitytask specific exercise

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Grip strength

    Pre-intervention (postoperative sixth week), immediately after the intervention (postoperative tenth week)

  • Change in active range of motion

    Pre-intervention (postoperative sixth week), immediately after the intervention (postoperative tenth week)

Study Arms (2)

Virtual Reality Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Consisted of patients who received the early passive mobilisation programme

Interventions

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.

Virtual Reality Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exergaming

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Medicine and Rehabilitation Resident

Study Record Dates

First Submitted

November 21, 2023

First Posted

January 10, 2024

Study Start

June 1, 2021

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

January 10, 2024

Record last verified: 2024-01

Locations