NCT00599742

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 24, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 24, 2008

Status Verified

January 1, 2008

Enrollment Period

3 years

First QC Date

January 11, 2008

Last Update Submit

January 23, 2008

Conditions

Keywords

Balance disorderVestibular disorderGeneralized anxiety disorderSeparation anxiety disorderChildrenBalance training

Outcome Measures

Primary Outcomes (1)

  • Balance improvement and anxiety reduction

    After 7 weeks of training

Study Arms (2)

A

ACTIVE COMPARATOR

Balance training group

Behavioral: Balance training

B

ACTIVE COMPARATOR

Motor Training

Behavioral: Motor training

Interventions

Physical exercise of balance. The training will last 7 weeks, twice per week, 1 hour per session.

A
Motor trainingBEHAVIORAL

Motor exercise of power and flexibility. The training will last 7 weeks, twice per week, 1 hour per session.

B

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Ages 8-14
  • Boy or girl
  • Generalized or separation anxiety disorder
  • Agreement to participate and written informed consent

You may not qualify if:

  • Major affective disorders
  • Severe developmental disorders
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Child and Adolescent Mental Health Clinic, Lev Hasharon MHC

Netanya, Israel

RECRUITING

Wingate Institute for Physical Education

Netanya, Israel

RECRUITING

Related 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. doi: 10.1016/S0887-6185(02)00291-8.

    PMID: 15125981BACKGROUND
  • 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.

    PMID: 11388353BACKGROUND

Related Links

MeSH Terms

Conditions

Anxiety DisordersVestibular DiseasesGeneralized Anxiety DisorderAnxiety, Separation

Condition Hierarchy (Ancestors)

Mental DisordersLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurodevelopmental Disorders

Study Officials

  • Michal Rappaport, MD

    Lev HaSharon Mental Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 11, 2008

First Posted

January 24, 2008

Study Start

December 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 24, 2008

Record last verified: 2008-01

Locations