Tendon Injury - HandNCT06198582
The Effect of Virtual Reality Based Task Specific Exercises in Patients With Hand Flexor Tendon Injury
A study testing Virtual Reality Exercises in people with Tendon Injury - Hand and Flexor Tendon Rupture, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tendon Injury - Hand, Flexor Tendon Rupture
- What is being tested?
- Virtual Reality Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tendon Injury - Hand, Flexor Tendon Rupture
- Being tested
- Virtual Reality Exercises
- Keywords
- flexor tendon rehabilitation, virtual reality, task specific exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Virtual Reality Exercises |
| Control Group | No intervention | Consisted of patients who received the early passive mobilisation programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Pre-intervention (postoperative sixth week), immediately after the intervention (postoperative tenth week)
Secondary outcomes (2)
Grip strength
The grip strength was measured with a Jamar dynamometer. The measured value was recorded in kilograms.
Measured: 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.
Measured: Pre-intervention (postoperative sixth week), immediately after the intervention (postoperative tenth week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Jun 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tendon Injury - HandStudies 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
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mert Karacay, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198582
- Sponsor's protocol ID
- 263799996/75
- Status last verified
- Jan 2024
- First submitted
- 21 Nov 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06198582
- Acronym / sponsor ID
- 263799996/75
- Conditions
- Tendon Injury - Hand, Flexor Tendon Rupture
- Keywords
- flexor tendon rehabilitation, virtual reality, task specific exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 10 Jan 2024 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Intervention Group | Experimental | Other: Virtual Reality ExercisesConsisted of patients who received a virtual reality-based task-specific exercise programme in addition to the early passive mobilisation programme |
| Control Group | No intervention | –Consisted of patients who received the early passive mobilisation programme |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Virtual Reality ExercisesIn 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. | Other | Virtual Reality Intervention Group |
Primary outcome
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.
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.
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.
2 secondary outcomes
Grip strength
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Exercises in people with Tendon Injury - Hand and Flexor Tendon Rupture, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in short form-36 (SF-36) scores (time frame: Pre-intervention (postoperative sixth week), immediately after the intervention (postoperative tenth week)). The study lists 3 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 10 Jan 2024.