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Biofeedback Gait Retraining to Reduce Lower Extremity Impact in Obese Children

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Biofeedback gait retraining
Exercise
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Childhood Obesity focused on measuring Childhood obesity, Ground reaction force, Knee pain

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Biofeedback gait retraining

Exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
Anthropometric measurements
Weight (Kg)
Anthropometric measurements
Height (Cm)
Anthropometric measurements
BMI ( kg/m^2)
VAS questionnaire
Visual analog score for pain (0-5)
Physicians global assessment questionnaire
To measure quality of life (0-5)

Secondary Outcome Measures

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

Full Information

First Posted
September 29, 2015
Last Updated
March 20, 2018
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02580825
Brief Title
Biofeedback Gait Retraining to Reduce Lower Extremity Impact in Obese Children
Official Title
Biofeedback Gait Retraining to Reduce Lower Extremity Impact in Obese Children
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Childhood obesity, Ground reaction force, Knee pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biofeedback gait retraining
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback gait retraining
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Each session will include a continuous exercise in which the patient will do walking, walking pace and running (3 minutes each section).
Primary Outcome Measure Information:
Title
GRF (ground reaction force)
Description
Reduction of ground reaction forces in three different modes of walking at an easy pace, pace and running ,measured by accelerometers (body weight).
Time Frame
8 weeks
Title
Anthropometric measurements
Description
Weight (Kg)
Time Frame
8 weeks
Title
Anthropometric measurements
Description
Height (Cm)
Time Frame
8 weeks
Title
Anthropometric measurements
Description
BMI ( kg/m^2)
Time Frame
8 weeks
Title
VAS questionnaire
Description
Visual analog score for pain (0-5)
Time Frame
8 weeks
Title
Physicians global assessment questionnaire
Description
To measure quality of life (0-5)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Postural deviations of the knee joint
Description
Reduction of abnormal positions of the knee such as valgus (degrees) and varus (degrees) by goniometer
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alon Eliakim, MD
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
the sports and health center for children and youth at "Meir" medical center
City
Kfar Sava
Country
Israel

12. IPD Sharing Statement

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Biofeedback Gait Retraining to Reduce Lower Extremity Impact in Obese Children

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