NCT05898568

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

9 months

First QC Date

June 2, 2023

Last Update Submit

January 31, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • Jebsen Taylor Hand Function Test

    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)

    marks the severity of pain between 0 and 10.

    from baseline to the end of the treatment (4 week)

  • duruöz hand index

    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)

    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)

    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

    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)

Study Arms (2)

experimental: virtual reality

EXPERIMENTAL

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

control:routine treatment

ACTIVE COMPARATOR

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

Behavioral: routine treatment

Interventions

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.

experimental: virtual reality

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

control:routine treatment

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, Arızlı, 41100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
occupational therapist

Study Record Dates

First Submitted

June 2, 2023

First Posted

June 12, 2023

Study Start

April 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations