Back to resultsVirtual Reality in Hand Peripheral Nerve Injuries Effectiveness of Based Movement Therapy
Primary Purpose
Peripheral Nerve Injury, Virtual Reality, Rehabilitation
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
virtual reality
routine treatment
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Nerve Injury, Virtual Reality, Rehabilitation
Eligibility Criteria
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
Sites / Locations
- Kocaeli UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
experimental: virtual reality
control:routine treatment
Arm Description
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.
20 sessions (4 weeks, 5 days a week, 60 minutes) routine hand rehabilitation program will be implemented.
Outcomes
Primary Outcome Measures
Jebsen Taylor Hand Function Test
Used to assess upper extremity functions. Activities are evaluated on a time basis.
visual analog scale (VAS)
marks the severity of pain between 0 and 10.
duruöz hand index
kitchen work, evaluates cleaning, workplace and other activities of daily living. The total score is between 0-90.
Sammes Weinstein Monofilament Test (SWMT)
sensory threshold is used for assessment.sensed monofilament values will be collected and recorded. The highest total score will be considered as 15.
Questionnaire Quick Disability of the Arm, Shoulder, and Hand (Quick DASH)
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.
Jamar dynamometer
Jamar dynamometer will be used for grip strength. 3 repetitive measurements will be made and the average will be recorded.(in kilograms)
Secondary Outcome Measures
Full Information
NCT ID
NCT05898568
First Posted
June 2, 2023
Last Updated
June 2, 2023
Sponsor
Kirsehir Ahi Evran University
1. Study Identification
Unique Protocol Identification Number
NCT05898568
Brief Title
Virtual Reality in Hand Peripheral Nerve Injuries Effectiveness of Based Movement Therapy
Official Title
Virtual Reality in Hand Peripheral Nerve Injuries Effectiveness of Based Movement Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to investigate the effectiveness of virtual reality-based motion therapy in peripheral nerve injuries in the hand.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Nerve Injury, Virtual Reality, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental: virtual reality
Arm Type
Experimental
Arm Description
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.
Arm Title
control:routine treatment
Arm Type
Active Comparator
Arm Description
20 sessions (4 weeks, 5 days a week, 60 minutes) routine hand rehabilitation program will be implemented.
Intervention Type
Device
Intervention Name(s)
virtual reality
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
routine treatment
Intervention Description
20 sessions (4 weeks, 5 days a week, 60 minutes) routine hand rehabilitation program will be applied.
Primary Outcome Measure Information:
Title
Jebsen Taylor Hand Function Test
Description
Used to assess upper extremity functions. Activities are evaluated on a time basis.
Time Frame
from baseline to the end of the treatment (4 week)
Title
visual analog scale (VAS)
Description
marks the severity of pain between 0 and 10.
Time Frame
from baseline to the end of the treatment (4 week)
Title
duruöz hand index
Description
kitchen work, evaluates cleaning, workplace and other activities of daily living. The total score is between 0-90.
Time Frame
from baseline to the end of the treatment (4 week)
Title
Sammes Weinstein Monofilament Test (SWMT)
Description
sensory threshold is used for assessment.sensed monofilament values will be collected and recorded. The highest total score will be considered as 15.
Time Frame
from baseline to the end of the treatment (4 week)
Title
Questionnaire Quick Disability of the Arm, Shoulder, and Hand (Quick DASH)
Description
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.
Time Frame
from baseline to the end of the treatment (4 week)
Title
Jamar dynamometer
Description
Jamar dynamometer will be used for grip strength. 3 repetitive measurements will be made and the average will be recorded.(in kilograms)
Time Frame
from baseline to the end of the treatment (4 week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kocaeli University
City
Kocaeli
State/Province
Arızlı
ZIP/Postal Code
41100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
serkan kablanoğlu, Phd
Phone
02623034771
Email
skaplanoglu00@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Virtual Reality in Hand Peripheral Nerve Injuries Effectiveness of Based Movement Therapy
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