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Comorbidity Between Balance and Childhood Anxiety
This study is currently recruiting participants.
Verified by Lev-Hasharon Mental Healtlh Center, January 2008
Sponsors and Collaborators: Lev-Hasharon Mental Healtlh Center
Tel Aviv University
Institute of Physical Education and Sports Sciences
University of Haifa
Information provided by: Lev-Hasharon Mental Healtlh Center
ClinicalTrials.gov Identifier: NCT00599742
  Purpose

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 Intervention
Anxiety
Behavioral: Balance training
Behavioral: Motor training

MedlinePlus related topics: Anxiety
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Randomized, Open Label, Parallel Assignment
Official Title: Comorbidity Between Balance and Childhood Anxiety: Treatment of Anxiety by Training of Balance

Further study details as provided by Lev-Hasharon Mental Healtlh Center:

Primary Outcome Measures:
  • Balance improvement and anxiety reduction [ Time Frame: After 7 weeks of training ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 64
Study Start Date: December 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator
Balance training group
Behavioral: Balance training
Physical exercise of balance. The training will last 7 weeks, twice per week, 1 hour per session.
B: Active Comparator
Motor Training
Behavioral: Motor training
Motor exercise of power and flexibility. The training will last 7 weeks, twice per week, 1 hour per session.

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.

  Eligibility

Ages Eligible for Study:   8 Years to 14 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

website of location of study  This link exits the ClinicalTrials.gov site
website of location of study  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Lev Hasharon Mental Health Center, Child and Adolescent Mental Health Clinic, ( Michal Rappaport MD )
Study ID Numbers: LH22/2007.CTIL, 920070174
Study First Received: January 11, 2008
Last Updated: January 23, 2008
ClinicalTrials.gov Identifier: NCT00599742  
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

Study placed in the following topic categories:
Anxiety Disorders
Anxiety, Separation
Vestibular Diseases

ClinicalTrials.gov processed this record on January 14, 2009