Virtual Reality in Hand Peripheral Nerve Injuries Effectiveness of Based Movement Therapy

Sponsor

Kocaeli University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05898568

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Nerve Injury, Virtual Reality, Rehabilitation	Device: virtual reality Behavioral: routine treatment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Virtual Reality in Hand Peripheral Nerve Injuries Effectiveness of Based Movement Therapy

Actual Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

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.	Device: virtual reality 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.	Behavioral: routine treatment 20 sessions (4 weeks, 5 days a week, 60 minutes) routine hand rehabilitation program will be applied.

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.

Device: virtual reality

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.

Behavioral: routine treatment

20 sessions (4 weeks, 5 days a week, 60 minutes) routine hand rehabilitation program will be applied.

Outcome Measures

Primary Outcome Measures

Jebsen Taylor Hand Function Test [from baseline to the end of the treatment (4 week)]
Used to assess upper extremity functions. Activities are evaluated on a time basis.
visual analog scale (VAS) [from baseline to the end of the treatment (4 week)]
marks the severity of pain between 0 and 10.
duruöz hand index [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.
Sammes Weinstein Monofilament Test (SWMT) [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.
Questionnaire Quick Disability of the Arm, Shoulder, and Hand (Quick DASH) [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.
Jamar dynamometer [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kocaeli University	Kocaeli	Arızlı	Turkey	41100

Sponsors and Collaborators

Kocaeli University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Serkan Kablanoğlu, occupational therapist, Kocaeli University

ClinicalTrials.gov Identifier:

NCT05898568

Other Study ID Numbers:

E-66175679-514.13.02-960185

First Posted:

Jun 12, 2023

Last Update Posted:

Jun 12, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Peripheral Nerve Injuries

Wounds and Injuries

Study Results

No Results Posted as of Jun 12, 2023