Comorbidity Between Balance and Childhood Anxiety
Primary Purpose
Anxiety
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Balance training
Motor training
Sponsored by
About this trial
This is an interventional basic science trial for Anxiety focused on measuring Balance disorder, Vestibular disorder, Generalized anxiety disorder, Separation anxiety disorder, Children, Balance training
Eligibility 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
Sites / Locations
- Child and Adolescent Mental Health Clinic, Lev Hasharon MHCRecruiting
- Wingate Institute for Physical EducationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A
B
Arm Description
Balance training group
Motor Training
Outcomes
Primary Outcome Measures
Balance improvement and anxiety reduction
Secondary Outcome Measures
Full Information
NCT ID
NCT00599742
First Posted
January 11, 2008
Last Updated
January 23, 2008
Sponsor
Lev-Hasharon Mental Healtlh Center
Collaborators
Tel Aviv University, Institute of Physical Education and Sports Sciences, University of Haifa
1. Study Identification
Unique Protocol Identification Number
NCT00599742
Brief Title
Comorbidity Between Balance and Childhood Anxiety
Official Title
Comorbidity Between Balance and Childhood Anxiety: Treatment of Anxiety by Training of Balance
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Lev-Hasharon Mental Healtlh Center
Collaborators
Tel Aviv University, Institute of Physical Education and Sports Sciences, University of Haifa
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Balance disorder, Vestibular disorder, Generalized anxiety disorder, Separation anxiety disorder, Children, Balance training
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Balance training group
Arm Title
B
Arm Type
Active Comparator
Arm Description
Motor Training
Intervention Type
Behavioral
Intervention Name(s)
Balance training
Intervention Description
Physical exercise of balance. The training will last 7 weeks, twice per week, 1 hour per session.
Intervention Type
Behavioral
Intervention Name(s)
Motor training
Intervention Description
Motor exercise of power and flexibility. The training will last 7 weeks, twice per week, 1 hour per session.
Primary Outcome Measure Information:
Title
Balance improvement and anxiety reduction
Time Frame
After 7 weeks of training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michal Rappaport, MD
Organizational Affiliation
Lev HaSharon Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child and Adolescent Mental Health Clinic, Lev Hasharon MHC
City
Netanya
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Rappaport, MD
Phone
+972-9-833-4466
Email
michalra@lev-hasharon.co.il
First Name & Middle Initial & Last Name & Degree
Michal Rappaport, MD
Facility Name
Wingate Institute for Physical Education
City
Netanya
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roni Lidor, PhD
Phone
+972-9-863-9247
Email
lidor@wincol.ac.il
First Name & Middle Initial & Last Name & Degree
Roni Lidor, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
15125981
Citation
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. doi: 10.1016/S0887-6185(02)00291-8.
Results Reference
background
PubMed Identifier
11388353
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. doi: 10.1016/s0887-6185(00)00039-6. No abstract available.
Results Reference
background
Links:
URL
http://www.lev-hasharon.co.il
Description
website of location of study
URL
http://www.jewishsports.net/wingate_institute.htm
Description
website of location of study
Learn more about this trial
Comorbidity Between Balance and Childhood Anxiety
We'll reach out to this number within 24 hrs