NCT03851367

Brief Summary

This study compares effect of swiss ball exercises with sling suspension exercises in the treatment of juvenile osteochondrosis in adolescent-girls

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

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

September 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

1.1 years

First QC Date

February 20, 2019

Last Update Submit

February 22, 2019

Conditions

Keywords

back painsuspension therapyGymballstanding posturemuscle endurance

Outcome Measures

Primary Outcomes (5)

  • Back pain

    was evaluated using the Visual Analogue Pain Scale (VAS). Participants were asked to report "current" pain intensity. A higher score indicates greater pain intensity: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm).

    baseline

  • Endurance of the trunk muscles

    was tested according those suggested by S. McGill (2007) and endurance duration was recorder in seconds. The back extensors ; The trunk flexors ; The lateral musculature

    baseline

  • Weight

    Body weight was measured in kilograms with an accuracy of 100 g

    baseline

  • Height

    Body height was measured in meters with an accuracy of 5 mm

    baseline

  • Posture evaluation

    Standing posture was evaluated by a commonly used clinical assessment technique - visual assessment. In an attempt to minimize data collection error, one experienced examiner evaluated all the study participants' posture. The examiner was blind to the scope of the study and to the group that the subjects belonged to.

    baseline

Secondary Outcomes (3)

  • Change in Back pain

    3 weeks

  • Change in Endurance of the trunk muscles

    3 weeks

  • Improvement in Posture evaluation

    3 weeks

Study Arms (2)

Sling suspension therapy

EXPERIMENTAL

3-week duration of exercises using red cord and consisting of 15 sessions for 30 minutes each.

Procedure: Sling suspension using red cord

Swiss ball therapy

ACTIVE COMPARATOR

3-week duration exercise for trunk muscles strengthening and posture improvement consisting of 15 sessions for 30 minutes each.

Procedure: Gym ball exercises

Interventions

3 weeks duration, 15 sessions, and 30 minutes a day for five consecutive days a week. Back pain, endurance of trunk muscles (flexors, extensors and side flexors), and standing posture were evaluated pre and post interventions.

Also known as: SST
Sling suspension therapy

3 weeks duration, 15 sessions, and 30 minutes a day for five consecutive days a week. Back pain, endurance of trunk muscles (flexors, extensors and side flexors), and standing posture were evaluated pre and post interventions.

Also known as: GBT
Swiss ball therapy

Eligibility Criteria

Age14 Years - 18 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly adolescents girls
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • diagnosis - juvenile osteochondrosis (according to the International classification of Diseases - ICD M 42 gender: female

You may not qualify if:

  • any other medical diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vilma Dudoniene

Kaunas, 44221, Lithuania

Location

MeSH Terms

Conditions

Scheuermann DiseaseBack Pain

Condition Hierarchy (Ancestors)

Spinal OsteochondrosisOsteochondrosisBone DiseasesMusculoskeletal DiseasesKyphosisSpinal CurvaturesSpinal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Subjects were recruited from an inpatient rehabilitation department, specializing in the treatment of children and adolescents with degenerative disorders. The research population consisted of 40 adolescents-girls, who were diagnosed with juvenile osteochondrosis (according to the International classification of Diseases - ICD M 42.0). All subjects were randomly divided into two groups: Sling Suspension Therapy, and Gymball therapy.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 22, 2019

Study Start

September 1, 2017

Primary Completion

September 30, 2018

Study Completion

December 30, 2018

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations