AnxietyNCT00599742
Comorbidity Between Balance and Childhood Anxiety
A study testing Balance training and Motor training in people with Anxiety, run by Lev-Hasharon Mental Healtlh Center at 2 sites in Israel.
Trial 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)… Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Balance training and Motor training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesIsrael
- Study dates
- Dec 2007to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 8-14
- Boy or girl
- Generalized or separation anxiety disorder
- Agreement to participate and written informed consent
Who cannot join
- Major affective disorders
- Severe developmental disorders
- Refusal to participate
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Child and Adolescent Mental Health Clinic, Lev Hasharon MHC
Netanya
Michal Rappaport, MD, +972-9-833-4466, michalra@lev-hasharon.co.il
Michal Rappaport, MD
- Recruiting
Wingate Institute for Physical Education
Netanya
Roni Lidor, PhD, +972-9-863-9247, lidor@wincol.ac.il
Roni Lidor, PhD
About this study
Official title: Comorbidity Between Balance and Childhood Anxiety: Treatment of Anxiety by Training of Balance
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Balance training, Motor training
- Keywords
- Balance disorder, Vestibular disorder, Generalized anxiety disorder, Separation anxiety disorder, Children, Balance training
- Medical subject headings
- Anxiety Disorders, Vestibular Diseases, Generalized Anxiety Disorder, Anxiety, Separation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance trainingBehavioural
Physical exercise of balance. The training will last 7 weeks, twice per week, 1 hour per session.
Motor trainingBehavioural
Motor exercise of power and flexibility. The training will last 7 weeks, twice per week, 1 hour per session.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Balance training group Receives: Behavioral: Balance training |
| B | Active comparator | Motor Training Receives: Behavioral: Motor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance improvement and anxiety reduction
Measured: After 7 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lev-Hasharon Mental Healtlh Center
- Sponsor type
- Other government
- Collaborators
- Tel Aviv University, Institute of Physical Education and Sports Sciences, University of Haifa
- Investigators
- Michal Rappaport, MD, Principal investigator, Lev HaSharon Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599742
- Sponsor's protocol ID
- LH22/2007.CTIL
- Other IDs
- 920070174
- Status last verified
- Jan 2008
- First submitted
- 11 Jan 2008
- Last updated
- 24 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 15125981Sklare 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.
PubMed 11388353
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comorbidity Between Balance and Childhood Anxiety: Treatment of Anxiety by Training of Balance
- ClinicalTrials.gov ID
- NCT00599742
- Acronym / sponsor ID
- LH22/2007.CTIL
- Conditions
- Anxiety
- Keywords
- Balance disorder, Vestibular disorder, Generalized anxiety disorder, Separation anxiety disorder, Children, Balance training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Lev-Hasharon Mental Healtlh CenterOther government
- Collaborators
- Tel Aviv University, Institute of Physical Education and Sports Sciences, University of Haifa
- Study start
- Dec 2007
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 24 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Behavioral: Balance trainingBalance training group |
| B | Active comparator | Behavioral: Motor trainingMotor Training |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Ages 8-14
- Boy or girl
- Generalized or separation anxiety disorder
- Agreement to participate and written informed consent
Key exclusion criteria (3 listed)
- Major affective disorders
- Severe developmental disorders
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance trainingPhysical exercise of balance. The training will last 7 weeks, twice per week, 1 hour per session. | Behavioural | A |
| Motor trainingMotor exercise of power and flexibility. The training will last 7 weeks, twice per week, 1 hour per session. | Behavioural | B |
Primary outcome
Balance improvement and anxiety reduction
Time frame: After 7 weeks of training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2008.
- Background: PubMed 15125981Erez 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.
- Background: PubMed 11388353Sklare 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.
- website of location of studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Child and Adolescent Mental Health Clinic, Lev Hasharon MHC
Netanya, Israel
Michal Rappaport, MD principal investigator
Lev HaSharon Mental Health Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance training and Motor training in people with Anxiety, run by Lev-Hasharon Mental Healtlh Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance improvement and anxiety reduction (time frame: After 7 weeks of training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00599742, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2008.