Comorbidity Between Balance and Childhood Anxiety

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Lev-Hasharon Mental Healtlh Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
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
First received: January 11, 2008
Last updated: January 23, 2008
Last verified: January 2008

January 11, 2008
January 23, 2008
December 2007
December 2010   (final data collection date for primary outcome measure)
Balance improvement and anxiety reduction [ Time Frame: After 7 weeks of training ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00599742 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comorbidity Between Balance and Childhood Anxiety
Comorbidity Between Balance and Childhood Anxiety: Treatment of Anxiety by Training of Balance

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Anxiety
  • Behavioral: Balance training
    Physical exercise of balance. The training will last 7 weeks, twice per week, 1 hour per session.
  • Behavioral: Motor training
    Motor exercise of power and flexibility. The training will last 7 weeks, twice per week, 1 hour per session.
  • Active Comparator: A
    Balance training group
    Intervention: Behavioral: Balance training
  • Active Comparator: B
    Motor Training
    Intervention: Behavioral: Motor training

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
64
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
8 Years to 14 Years
No
Not Provided
Israel
 
NCT00599742
LH22/2007.CTIL, 920070174
Yes
Michal Rappaport MD, Lev Hasharon Mental Health Center, Child and Adolescent Mental Health Clinic,
Lev-Hasharon Mental Healtlh Center
  • Tel Aviv University
  • Institute of Physical Education and Sports Sciences
  • University of Haifa
Principal Investigator: Michal Rappaport, MD Lev-Hasharon Mental Health Center
Lev-Hasharon Mental Healtlh Center
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP