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
  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

Study Type: Interventional
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

Resource links provided by NLM:


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
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
Responsible Party: Michal Rappaport MD, Lev Hasharon Mental Health Center, Child and Adolescent Mental Health Clinic,
ClinicalTrials.gov Identifier: NCT00599742     History of Changes
Other Study ID Numbers: LH22/2007.CTIL, 920070174
Study First Received: January 11, 2008
Last Updated: January 23, 2008
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

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 19, 2014