NCT02954718

Brief Summary

Juvenile idiopathic arthritis (JIA) is most common chronic rheumatic disease in childhood. The upper extremity involvement in JIA causes muscle imbalance, joint destruction, pain, stiffness and limitations on daily living activities (DLA) in varying degrees. However, the information about prevalence of symptoms, disorders, DLA limitations, participation restriction and options of treatments for upper extremity involvement in JIA are limited. It has been reported that improvements of upper extremity functions were achieved by video-based games (VBG) in various disease groups. However, in the literature, no study has been found about effectiveness of WBG in children with arthritis. The aim of the study was to investigate effects of task-oriented activity training (TOAT) with VBG versus activity training in real life on activity performance and participation in children with arthritis. Participants with upper limb involvement in JIA were randomly assigned to the activity training in real life group (group I) and TOAT with VBG in real life group (group II). The actual materials and rehabilitation kits will be used for activity training in group 1, the DLA that expected to gain independence will be trained with VBG in group 2. Upper extremity muscle strength and grip, range of motion, upper limb functions, activity, participation and quality of life will be evaluated. The hypothesis of this study is that TOAT with VBG improves the activity performance and physical functions and increases the participation, via being stimulative and interactive in order to provide feedback and to increase interest and motivation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2016

Completed
Last Updated

November 4, 2016

Status Verified

February 1, 2015

Enrollment Period

1.8 years

First QC Date

November 2, 2016

Last Update Submit

November 3, 2016

Conditions

Video-based Task Oriented Activity Training

Keywords

activity performancejuvenile idiopathic arthritisvirtual reality

Outcome Measures

Primary Outcomes (2)

  • Childhood Health Assessment Questionaire (CHAQ)

    8 weeks

  • Canadian Occupational Performance Measure (COPM)

    8 weeks

Secondary Outcomes (2)

  • Duruoz Hand Index

    8 weeks

  • Jebsen-Taylor Hand Function Test (JTHFT)

    8 weeks

Study Arms (2)

1

EXPERIMENTAL

patient-centered task oriented activity training in real life

Other: activity training

2

EXPERIMENTAL

patient-centered video-based task oriented activity training

Other: activity training

Interventions

activity trainingOTHER
Also known as: exercise training
12

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosed as JIA according to ILAR classification
  • Aged between 6-18
  • At least one affected joint in upper extremity (shoulder, elbow, wrist, and hand joints)
  • Adequate cognitive function in the compliance of exercise program

You may not qualify if:

  • Surgery or arthroscopic operation in the last year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Arman N, Tarakci E, Tarakci D, Kasapcopur O. Effects of Video Games-Based Task-Oriented Activity Training (Xbox 360 Kinect) on Activity Performance and Participation in Patients With Juvenile Idiopathic Arthritis: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2019 Mar;98(3):174-181. doi: 10.1097/PHM.0000000000001001.

    PMID: 30020092DERIVED

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Exercise

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 3, 2016

Study Start

February 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 4, 2016

Record last verified: 2015-02