NCT05912478

Brief Summary

The scapula provides the base of the kinetic chain, which is stabilized by the surrounding muscles. Considering that activating the scapular musculature to stabilize the spine would restore the relationship between body segments, analyzing the scapular muscle activations in the treatment of hyperkyphosis may be a crucial component of an effective therapeutic program. Video games can be used to stimulate scapular muscles in children with thoracic hyperkyphosis because a game-based exercise program has been observed to increase voluntary motor control in children, thereby promoting selective muscle activation. The purpose of this study is to investigate the impact of video game therapy on the activation of scapular muscles and postural stability in children with thoracic hyperkyphosis, as well as the contribution of these variables to upper extremity performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

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

First Submitted

Initial submission to the registry

June 13, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

February 25, 2025

Status Verified

July 1, 2024

Enrollment Period

8 months

First QC Date

June 13, 2023

Last Update Submit

February 24, 2025

Conditions

Keywords

video gameshyperkyphosisstabilitysapulamuscle activationposture

Outcome Measures

Primary Outcomes (9)

  • Muscle Activation

    The electrical activity of the muscle during rest and contraction is called electromyogram, and recording this activity is called electromyography (EMG). Superficial EMG (yEMG) is preferred in physiotherapy and rehabilitation researches due to its noninvasive nature, no risk of infection and ease of use. In our study, Noraxon Myosystem (Noraxon Inc., Scottsdale, AZ, USA) yEMG will be used to measure the electrical activity of the upper, middle and lower trapezius, pectoralis major, and serratus anterior muscles. Electrodes will be placed in orientation parallel to the identified muscle fibers as recommended by "Surface ElectroMyoGraphy for the Non-Invasive Assessments of Muscles SENIAM)". Activations of these muscles will be recorded as a percentage of maximum voluntary isometric contraction (%MVIC). In addition, analyzes will be made about fatigue, coactivation and activation time of the muscles.

    8 weeks

  • Muscle Tone and Stiffness

    MyotonPRO (Muomeetria Ltd., Tallinn, Estonia) will be used to measure the tone and stiffness of the upper, middle and lower trapezius, pectoralis major and serratus anterior muscles. Myotonometry reflects the viscoelastic properties of the muscle such as tone and stiffness by creating oscillation in the muscle fiber and is an acceptable and reliable method for measuring the mechanical properties of the muscles. In our study, after the participants rest for 5 minutes, the arms will be left relaxed in the sitting position and the measurement will be taken from the most swollen part of the relevant muscles. During the measurement, the test probe of the myotonometer will be placed vertically on the skin surface. The measurement will be started by pushing the probe to the required depth on the skin surface. Whether the required depth has been reached or not will be checked by turning the indicator light on the device from red to green.

    8 weeks

  • Posture

    PostureScreen Mobile software is a valid and reliable application that evaluates the changes in a person's posture. In our study, the evaluation of frontal and sagittal plane posture will be calculated by marking reference points on the photographs taken from the front, back and sides of the patient in the PostureScreen Mobile application.Photographing, positioning and determination of reference points of the participants will be standardized. During the photo shoot, the feet of the participants will be positioned bare and parallel to each other, attention will be paid to the absence of clothing and the bulk of the hair so that the reference points are clear. During the shoot, participants will be asked to keep their arms loose and look straight ahead.

    8 weeks

  • Satisfaction with Body Image

    Since there is no scale specific to hyperkyphosis deformity in the literature that evaluates individuals' own perception of cosmetic deformity, a numerical rating scale with values between 0-10 will be used to evaluate how the perception of cosmetic deformity changes.

    8 weeks

  • Perception of Spinal Deformity

    Perception of spinal deformity will be assessed with the Kyphosis-Specific Spinal Appearance Questionnaire.The Kyphosis Specific Spinal Appearance Questionnaire has been developed to assess appearance in hyperkyphosis patients. The KSAQ included 10 items on a Likert scale (1 to 5) regarding patients' perceptions of appearance, with higher scores indicating worsening deformity and greater kyphosis-specific appearance concern

    8 weeks

  • Medicine Ball Throwing Test

    It will be used to evaluate the explosive power of the upper extremity. Participants will be positioned in a chair without armrests in an upright position with their ankle, knee and hip joints at 90 degrees. He will be asked to grasp the 3 kg medicine ball with both hands and throw it forward over the head without bending his body forward and without flexing his elbows. The first point where the ball touches the ground will be measured from the starting point and the value will be recorded in cm. The test will be repeated three times and the average of the values recorded. The test of the participants will be invalidated and the test will be repeated if they throw the ball down to the level of their neck or make the throw by leaning forward from the trunk.

    8 weeks

  • Closed Kinetic Chain Upper Extremity Stability Test

    It will be used to evaluate upper extremity strength, endurance and closed kinetic chain. The test will also be performed following the guidelines described by Oliveira et al. During the test, male participants will be placed in the push-up position, and female participants in the modified push-up position (with knee support), on 2 tapes glued to the floor with a distance of 90 cm between the two hands. Participants will be asked to touch the other hand with one hand while maintaining the push-up position for 15 seconds, and the number of reps completed for the right and left will be recorded. The test will be repeated three times and the average of the values recorded. There will be 45-second rest breaks between each test. In the test-retest reliability study of the test in adolescents, the intraclass correlation coefficient (ICC) was found to be 0.68.

    4 months

  • Scapular Endurance Test

    The endurance of the scapular muscles will be evaluated with the Scapular Muscular Endurance Test. The Scapular Muscular Endurance Test will be performed with the participants facing the wall in a standing position, with the shoulders and elbows in the 90° flexion position. With both scapulae in neutral position, the participant will place the most appropriate length of 10 wooden sticks (18-36 cm) between their elbows and a dynamometer between their hands. While in this position, the participant will be asked to perform external rotation of the shoulder and maintain this force until a load of one kilogram is reached on the dynamometer, and the results will be recorded in seconds. The test will be terminated if the participant is unable to maintain the applied resistance, drops the bar between their elbows, or is unable to maintain 90 degrees of shoulder flexion and becomes unbearable

    8 weeks

  • Reaction time

    Nelson Hand Reaction Test will be used to evaluate reaction speed. The test is performed while the subject sits in a chair, placing his hands on the table's edge with the palms facing each other. The little fingers of both hands are in contact with the edge of the table and there is a distance of 30 cm between them. The therapist holds the wooden ruler at the midpoint of the subject's fingers. The ruler is left after the subject gains attention with the therapist's "Ready" command (0.5-2 seconds). The subject holds the ruler by squeezing it between both hands with a horizontal movement as soon as possible. Once the ruler is captured, the reading at the point just above the top edge of the hand is recorded.

    8 weeks

Secondary Outcomes (8)

  • Demographic and Clinical Characteristics

    8 weeks

  • Flexicurve Rule

    8 weeks

  • Wall-Occiput Distance Measurement:

    8 weeks

  • The Numerical Rating Scale

    8 weeks

  • Muscle Strength

    8 weeks

  • +3 more secondary outcomes

Study Arms (2)

Study group

EXPERIMENTAL

Videogame-Based Therapy Games for the Nintendo Switch (Version 2) will be used for eight weeks, three days per week, for a total of 24 sessions.

Other: Videogame-Based Therapy

Control Group

OTHER

The participants on the waiting list will be evaluated as the control group. For eight weeks, the control group will be instructed to maintain their daily routine.

Other: Waiting list

Interventions

The Nintendo Switch (Version 2) will be used to play video games. Within the scope of the study, Nintendo Switch games were analyzed with respect to their technical and fictional characteristics, required and optional movement patterns, difficulty levels, transitions between difficulty levels, and compatibility with priority problems. The selected activities will prioritize the activation of the scapular muscles. Throughout the activities, the participant will be required to mimic the on-screen avatar's movements. The player will receive a higher score if his or her movements in the game resemble the avatar's in terms of angular, velocity, and fluidity.

Study group

The participants who were placed on a waiting list for eight weeks and constituted the control group will be asked to carry on with their normal activities. Participants in the control group will be contacted by phone in the fourth week to inquire about their status and to remind them that the exercise program will begin in the coming weeks. At the end of the 8-week study, the participants from the control group will participate in the exercise program.

Control Group

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Thoracic kyphosis angle (Cobb): ≥40˚- \<65˚ on lateral radiograph
  • Age between 7-18 years

You may not qualify if:

  • Those with congenital or rigid deformity/anomaly in the spinal area
  • Those who have had major surgery or trauma related to the musculoskeletal system, especially the spinal region
  • Those who received physiotherapeutic intervention in the spinal region in the last 6 months
  • Those who use corsets
  • Having a BMI ≥30
  • Those who are interested in sports in which the upper extremity is regularly used actively (swimming, volleyball, tennis, handball, etc.) Those who have visual problems and are sensitive to light.
  • Those with vestibular problems (Unterberger test positive)
  • Those with hearing problems
  • Those who have difficulty perceiving the given commands
  • Those with systemic diseases (Diabetes, hypothyroidism, infection, malignancy...)
  • Those with neurological disease
  • Those with rheumatic disease in the active phase

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

KyphosisMuscle Weakness

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesMuscular DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Ayse Zengin Alpozgen, Asst. Prof.

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assos. Prof

Study Record Dates

First Submitted

June 13, 2023

First Posted

June 22, 2023

Study Start

March 1, 2024

Primary Completion

October 15, 2024

Study Completion

December 15, 2024

Last Updated

February 25, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations