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Comorbidity Between Balance and Childhood Anxiety

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ClinicalTrials.gov Identifier: NCT00599742
Recruitment Status : Unknown
Verified January 2008 by Lev-Hasharon Mental Healtlh Center.
Recruitment status was:  Recruiting
First Posted : January 24, 2008
Last Update Posted : January 24, 2008
Sponsor:
Collaborators:
Tel Aviv University
Institute of Physical Education and Sports Sciences
University of Haifa
Information provided by:
Lev-Hasharon Mental Healtlh Center

Brief Summary:
Previous studies report frequent comorbidity of anxiety and sensory-motor imbalance in adults (Sklare et al., 2001). Only a few studies tested the comorbidity in children. We confirmed that: a) children with primary diagnosis of poor balance demonstrate an elevated anxiety level (Brat et al., 2006, submitted) and, b) children with primary diagnosis of generalized anxiety disorder demonstrate poor balance performance (Erez et al., 2004). These studies demonstrate the presence of balance-anxiety comorbidity in children with primary disorder of either balance or anxiety. Our theoretical reasoning formalized under the "three stage theory of learning" points to the possibility that poor balance may either predispose or cause the emergence of anxiety disorder (Erez et al., 2004). Thus, in the present study we test two predictions: (a) high prevalence of comorbidity of anxiety and balance disorders in children with a primary diagnosis of generalized or separation anxiety disorder, and, (b) intensive balance training, but not training of flexibility and power, will reduce the level of anxiety in children with primary diagnosis of anxiety.

Condition or disease Intervention/treatment Phase
Anxiety Behavioral: Balance training Behavioral: Motor training Not Applicable

Detailed Description:

Study sample: 64 children, 8 to 14 years old, with diagnosis of generalized or separation anxiety.

Training: 32 of these children will undergo balance training and the other 32 children will undergo motor training of power and flexibility. Training will last 7 weeks, twice per week, 1 hr each session.

Tests: Balance and anxiety tests will be applied before training period, immediately after the last training session and again 2 months after the last training session.

Tests will include standard balance performance tests and questionnaires of anxiety.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Comorbidity Between Balance and Childhood Anxiety: Treatment of Anxiety by Training of Balance
Study Start Date : December 2007
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: A
Balance training group
Behavioral: Balance training
Physical exercise of balance. The training will last 7 weeks, twice per week, 1 hour per session.

Active Comparator: B
Motor Training
Behavioral: Motor training
Motor exercise of power and flexibility. The training will last 7 weeks, twice per week, 1 hour per session.




Primary Outcome Measures :
  1. Balance improvement and anxiety reduction [ Time Frame: After 7 weeks of training ]


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Ages Eligible for Study:   8 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 8-14
  • Boy or girl
  • Generalized or separation anxiety disorder
  • Agreement to participate and written informed consent

Exclusion Criteria:

  • Major affective disorders
  • Severe developmental disorders
  • Refusal to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00599742


Locations
Israel
Child and Adolescent Mental Health Clinic, Lev Hasharon MHC Recruiting
Netanya, Israel
Contact: Michal Rappaport, MD    +972-9-833-4466    michalra@lev-hasharon.co.il   
Principal Investigator: Michal Rappaport, MD         
Wingate Institute for Physical Education Recruiting
Netanya, Israel
Contact: Roni Lidor, PhD    +972-9-863-9247    lidor@wincol.ac.il   
Sub-Investigator: Roni Lidor, PhD         
Sponsors and Collaborators
Lev-Hasharon Mental Healtlh Center
Tel Aviv University
Institute of Physical Education and Sports Sciences
University of Haifa
Investigators
Principal Investigator: Michal Rappaport, MD Lev-Hasharon Mental Health Center

Additional Information:
Publications:
Responsible Party: Michal Rappaport MD, Lev Hasharon Mental Health Center, Child and Adolescent Mental Health Clinic,
ClinicalTrials.gov Identifier: NCT00599742     History of Changes
Other Study ID Numbers: LH22/2007.CTIL
920070174
First Posted: January 24, 2008    Key Record Dates
Last Update Posted: January 24, 2008
Last Verified: January 2008

Keywords provided by Lev-Hasharon Mental Healtlh Center:
Balance disorder
Vestibular disorder
Generalized anxiety disorder
Separation anxiety disorder
Children
Balance training

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders