- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05898568
Virtual Reality in Hand Peripheral Nerve Injuries Effectiveness of Based Movement Therapy
January 31, 2024 updated by: Serkan Kablanoğlu, Kocaeli University
The aim of this study is to investigate the effectiveness of virtual reality-based motion therapy in peripheral nerve injuries in the hand.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- 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
-
-
Arızlı
-
Kocaeli, Arızlı, Turkey, 41100
- Kocaeli University
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- ıt was operated in the early period with the diagnosis of peripheral nerve injury in the postoperative hand.
- clinical impression was made.
- out patient with median, ulnar, and radial nerve repair.
- completed the 6th postoperative week.
Exclusion Criteria:
- Those who have communication problems and users
- With the musculoskeletal system, the additional passage, rheumatological, etc., where they are located.
those with the disease
- Patients with multiple traumas
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental: virtual reality
In addition to routine hand care programs for 4 weeks, 5 days, 40 minutes a day, 20 sessions (4 weeks, 5 days, 20 minutes) virtual reality based movement therapy program will be applied.
|
In addition to the routine hand rehabilitation programs for 4 weeks, 5 days, 40 minutes a day, 20 sessions (4 weeks, 5 days a week, 20 minutes) virtual reality based movement therapy program will be applied.
|
|
Active Comparator: control:routine treatment
20 sessions (4 weeks, 5 days a week, 60 minutes) routine hand rehabilitation program will be implemented.
|
20 sessions (4 weeks, 5 days a week, 60 minutes) routine hand rehabilitation program will be applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Jebsen Taylor Hand Function Test
Time Frame: from baseline to the end of the treatment (4 week)
|
Used to assess upper extremity functions.
Activities are evaluated on a time basis.
|
from baseline to the end of the treatment (4 week)
|
|
visual analog scale (VAS)
Time Frame: from baseline to the end of the treatment (4 week)
|
marks the severity of pain between 0 and 10.
|
from baseline to the end of the treatment (4 week)
|
|
duruöz hand index
Time Frame: from baseline to the end of the treatment (4 week)
|
kitchen work, evaluates cleaning, workplace and other activities of daily living.
The total score is between 0-90.
|
from baseline to the end of the treatment (4 week)
|
|
Sammes Weinstein Monofilament Test (SWMT)
Time Frame: from baseline to the end of the treatment (4 week)
|
sensory threshold is used for assessment.sensed
monofilament values will be collected and recorded.
The highest total score will be considered as 15.
|
from baseline to the end of the treatment (4 week)
|
|
Questionnaire Quick Disability of the Arm, Shoulder, and Hand (Quick DASH)
Time Frame: from baseline to the end of the treatment (4 week)
|
activity participation level will be assessed by Q-DASH.Each question will be scored between 1-5 points (1: no difficulty, 2: mild difficulty, 3: medium difficulty, 4: extreme difficulty, 5: not at all).
The total score will be recorded.
|
from baseline to the end of the treatment (4 week)
|
|
Jamar dynamometer
Time Frame: from baseline to the end of the treatment (4 week)
|
Jamar dynamometer will be used for grip strength.
3 repetitive measurements will be made and the average will be recorded.(in
kilograms)
|
from baseline to the end of the treatment (4 week)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
April 1, 2023
Primary Completion (Actual)
January 1, 2024
Study Completion (Actual)
January 1, 2024
Study Registration Dates
First Submitted
June 2, 2023
First Submitted That Met QC Criteria
June 2, 2023
First Posted (Actual)
June 12, 2023
Study Record Updates
Last Update Posted (Estimated)
February 1, 2024
Last Update Submitted That Met QC Criteria
January 31, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-66175679-514.13.02-960185
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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