Comorbidity Between Balance and Childhood Anxiety
Recruitment status was Recruiting
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 Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Comorbidity Between Balance and Childhood Anxiety: Treatment of Anxiety by Training of Balance|
- Balance improvement and anxiety reduction [ Time Frame: After 7 weeks of training ] [ Designated as safety issue: Yes ]
|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)|
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
Behavioral: Motor training
Motor exercise of power and flexibility. The training will last 7 weeks, twice per week, 1 hour per session.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00599742
|Child and Adolescent Mental Health Clinic, Lev Hasharon MHC||Recruiting|
|Contact: Michal Rappaport, MD +972-9-833-4466 email@example.com|
|Principal Investigator: Michal Rappaport, MD|
|Wingate Institute for Physical Education||Recruiting|
|Contact: Roni Lidor, PhD +972-9-863-9247 firstname.lastname@example.org|
|Sub-Investigator: Roni Lidor, PhD|
|Principal Investigator:||Michal Rappaport, MD||Lev-Hasharon Mental Health Center|