Comorbidity Between Balance and Childhood Anxiety

Anxiety Clinical Trial

Official title:

Comorbidity Between Balance and Childhood Anxiety: Treatment of Anxiety by Training of Balance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00599742
• Other study ID #: LH22/2007.CTIL
• Secondary ID: 920070174
• Status: Recruiting
• Phase: N/A
• First received: January 11, 2008
• Last updated: January 23, 2008
• Start date: December 2007
• Est. completion date: December 2010

Study information

• Verified date: January 2008
• Source: Lev-Hasharon Mental Healtlh Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• Balance training
Physical exercise of balance. The training will last 7 weeks, twice per week, 1 hour per session.
• Motor training
Motor exercise of power and flexibility. The training will last 7 weeks, twice per week, 1 hour per session.

Locations

Country	Name	City	State
Israel	Child and Adolescent Mental Health Clinic, Lev Hasharon MHC	Netanya
Israel	Wingate Institute for Physical Education	Netanya

Sponsors (4)

Lead Sponsor	Collaborator
Lev-Hasharon Mental Healtlh Center	Institute of Physical Education and Sports Sciences, Tel Aviv University, University of Haifa

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Erez O, Gordon CR, Sever J, Sadeh A, Mintz M. Balance dysfunction in childhood anxiety: findings and theoretical approach. J Anxiety Disord. 2004;18(3):341-56. — View Citation

Sklare DA, Konrad HR, Maser JD, Jacob RG. Special issue on the interface of balance disorders and anxiety: an introduction and overview. J Anxiety Disord. 2001 Jan-Apr;15(1-2):1-7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Balance improvement and anxiety reduction		After 7 weeks of training	Yes

External Links

•   website of location of study
•   website of location of study