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Completed

NCT Number: NCT02580825

Biofeedback Gait Retraining to Reduce Lower Extremity Impact in Obese Children

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.

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Kfar Saba, Israel

About this study

This study will include approximately 50 patients, aged 7-12 years. All participants and their parents will sign an informed consent form before entering the study. At the beginning, participants are asked to answer a "vas scale" questionnaire for pain. Participants will be recruited from the population of overweight children from children's sports medical center 'Meir' in Kfar Saba. In the first stage the participants will be divided randomly into two groups of intervention and control. All children will take a test of 1 km and will be instructed to walk in the maximum phase before running (at the maximum it that the child can go without running) for calculating and determine the rate of 1.0 during the assessment of the intervention program for each participant. In addition, measures of the knees (valgus) will be made by a Goniometer, which is a protractor that measures angles between bones at a precise angle.

Each participant will fill a questionnaire about pain and difficulty from which he suffers in the knee. Participants will describe to the researcher the degree of pain and / or discomfort in motion (such as walking, running) and then pass a physical examination to diagnose a knee injury.

The intervention program will take four weeks while in each week their will be two exercise session 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 (be guided to land more "light", "soft" landing with a smaller noise). In all training the time that the biofeedback is shown will be reduced. The control group will receive the same training program without providing biofeedback. Each participant will perform the test with his personality shoes. At the end of the intervention program will be a statistical comparative test of the GRF that developed in the knee Relative to each child Vs his original GRF and the group averages.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Biofeedback gait retraining

Behavioral

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.

Exercise

Behavioral

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

Primary outcomes

  1. GRF (ground reaction force)

    Time frame: 8 weeks

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

  2. Anthropometric measurements

    Time frame: 8 weeks

    Weight (Kg)

  3. Anthropometric measurements

    Time frame: 8 weeks

    Height (Cm)

  4. Anthropometric measurements

    Time frame: 8 weeks

    BMI ( kg/m^2)

  5. VAS questionnaire

    Time frame: 8 weeks

    Visual analog score for pain (0-5)

  6. Physicians global assessment questionnaire

    Time frame: 8 weeks

    To measure quality of life (0-5)

Secondary outcomes

  1. Postural deviations of the knee joint

    Time frame: 8 weeks

    Reduction of abnormal positions of the knee such as valgus (degrees) and varus (degrees) by goniometer

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 20, 2015
Registry last updated
Mar 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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