NCT02580825

Brief Summary

The purpose of the study is to explore if self biofeedback program can reduce ground reaction force (GRF) from the lower extremity of the body and in the knee in particular and help obese children to avoid knee injuries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

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

September 29, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

March 21, 2018

Status Verified

January 1, 2017

Enrollment Period

1.6 years

First QC Date

September 29, 2015

Last Update Submit

March 20, 2018

Conditions

Childhood Obesity

Keywords

Childhood obesityGround reaction forceKnee pain

Outcome Measures

Primary Outcomes (6)

  • GRF (ground reaction force)

    Reduction of ground reaction forces in three different modes of walking at an easy pace, pace and running ,measured by accelerometers (body weight).

    8 weeks

  • Anthropometric measurements

    Weight (Kg)

    8 weeks

  • Anthropometric measurements

    Height (Cm)

    8 weeks

  • Anthropometric measurements

    BMI ( kg/m\^2)

    8 weeks

  • VAS questionnaire

    Visual analog score for pain (0-5)

    8 weeks

  • Physicians global assessment questionnaire

    To measure quality of life (0-5)

    8 weeks

Secondary Outcomes (1)

  • Postural deviations of the knee joint

    8 weeks

Study Arms (2)

Biofeedback gait retraining

ACTIVE COMPARATOR

The intervention program will take four weeks while in each week their will be two exercise sessions and a total of 8 sessions. Each session length is about 9 minutes. Each session will include a continuous exercise in which the patient will do walking, walking pace and running (3 minutes each section). During the meeting, participant will receive biofeedback that will displayed on a computer screen that shows the forces that develop in the knee joint so that the patient can see graphically the forces that develop around the knee joint and will be guided / try to reduce the values of the graph by changing the intensity of his landing on the tracks. In all training the time that the biofeedback is shown will be reduced.

Behavioral: Biofeedback gait retraining

Exercise

ACTIVE COMPARATOR

The control group will receive the same training program: four weeks while in each week their will be two exercise sessions and a total of 8 sessions. Each session length is about 9 minutes. Each session will include a continuous exercise in which the patient will do walking, walking pace and running (3 minutes each section). This group will not provide the biofeedback.

Behavioral: Exercise

Interventions

Biofeedback gait retrainingBEHAVIORAL

Each session will include a continuous exercise in which the patient will do walking, walking pace and running (3 minutes each section). During the meeting, participant will receive biofeedback that will displayed on a computer screen that shows the forces that develop in the knee joint so that the patient can see graphically the forces that develop around the knee joint and will be guided / try to reduce the values of the graph by changing the intensity of his landing on the tracks. In all training the time that the biofeedback is shown will be reduced.

Biofeedback gait retraining
ExerciseBEHAVIORAL

Each session will include a continuous exercise in which the patient will do walking, walking pace and running (3 minutes each section).

Exercise

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children, boys and girls, ages 7-12.
  • Children with overweight defined as BMI percentile over 85%
  • Children who are able to perform moderate physical activity.
  • Children who are able to understand and perform simple directions according to their age.

You may not qualify if:

  • Participant that does not wish to participate - will not be obligated to do so, and shall not participate in the study.
  • Participants with a history of chronic knee injuries
  • Participants with a background in competitive sport will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the sports and health center for children and youth at "Meir" medical center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alon Eliakim, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2015

First Posted

October 20, 2015

Study Start

January 1, 2016

Primary Completion

August 1, 2017

Study Completion

October 1, 2017

Last Updated

March 21, 2018

Record last verified: 2017-01

Locations

IL(1)