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Sponsors and Collaborators: |
Lev-Hasharon Mental Healtlh Center Tel Aviv University Institute of Physical Education and Sports Sciences University of Haifa |
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Information provided by: | Lev-Hasharon Mental Healtlh Center |
ClinicalTrials.gov Identifier: | NCT00599742 |
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 |
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Anxiety |
Behavioral: Balance training Behavioral: Motor training |
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 |
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 |
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A: Active Comparator
Balance training group
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Behavioral: Balance training
Physical exercise of balance. The training will last 7 weeks, twice per week, 1 hour per session.
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B: Active Comparator
Motor Training
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Behavioral: Motor training
Motor exercise of power and flexibility. The training will last 7 weeks, twice per week, 1 hour per session.
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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.
Ages Eligible for Study: | 8 Years to 14 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Michal Rappaport, MD | Lev-Hasharon Mental Health Center |
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 |
Balance disorder Vestibular disorder Generalized anxiety disorder |
Separation anxiety disorder Children Balance training |
Anxiety Disorders Anxiety, Separation Vestibular Diseases |