- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00599742
Comorbidity Between Balance and Childhood Anxiety
Comorbidity Between Balance and Childhood Anxiety: Treatment of Anxiety by Training of Balance
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Netanya, Israel
- Recruiting
- Child and Adolescent Mental Health Clinic, Lev Hasharon MHC
-
Contact:
- Michal Rappaport, MD
- Phone Number: +972-9-833-4466
- Email: michalra@lev-hasharon.co.il
-
Principal Investigator:
- Michal Rappaport, MD
-
Netanya, Israel
- Recruiting
- Wingate Institute for Physical Education
-
Contact:
- Roni Lidor, PhD
- Phone Number: +972-9-863-9247
- Email: lidor@wincol.ac.il
-
Sub-Investigator:
- Roni Lidor, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: A
Balance training group
|
Physical exercise of balance.
The training will last 7 weeks, twice per week, 1 hour per session.
|
|
Active Comparator: B
Motor Training
|
Motor exercise of power and flexibility.
The training will last 7 weeks, twice per week, 1 hour per session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Balance improvement and anxiety reduction
Time Frame: After 7 weeks of training
|
After 7 weeks of training
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michal Rappaport, MD, Lev Hasharon Mental Health Center
Publications and helpful links
General Publications
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LH22/2007.CTIL
- 920070174
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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