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STEP: Enhanced Physical Activity in Children and Youth With Epilepsy (STEP)

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ClinicalTrials.gov Identifier: NCT01550874
Recruitment Status : Recruiting
First Posted : March 12, 2012
Last Update Posted : September 23, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
Hypothesis: The investigators hypothesize that a pedometer-based motivated 6-months walking program will result in sustainable enhanced PA.

Condition or disease Intervention/treatment
Physical Activity Epilepsy Seizures Children Motivation Behavioral: Motivation

Detailed Description:
Enhanced PA will in turn positively influence health, social participation and QoL of sedentary CWE through multiple pathways. These will involve biomedical factors (i.e. attention deficit, depression, anxiety and sleep disorders); and contextual environmental and personal factors that include psychosocial factors at the child, family and community level (Figure 1).21 These factors may include family stressors, social support, self-efficacy, and autonomy.22 We expect that enhanced, sustained PA will improve health, functioning and QoL of CWE through its potential neuroprotective and circadian rhythm regulatory effects, and by increasing social participation, promoting a positive outlook on life and self-image, decreasing worries and concerns, decreasing emotional problems and the concealment of epilepsy, and delaying secondary health complications.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Official Title: STEP: Enhanced Physical Activity in Children and Youth With Epilepsy: Developing Evidence of Impacts on Health, Functioning, Psychological Wellbeing, and Quality of Life
Study Start Date : April 2012
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Control Group
Sedentary children with epilepsy will maintain step count for 6 months and then be asked to increase the step count.
Experimental: Experimental Group
Sedentary Children with epilepsy, increase the step count weekly with phon-based motivational coaching strategies for 6 months and then check sustainability without further motivational support for another 6 months.
Behavioral: Motivation
Participants in the experimental group will be motivated by augmented behavior modification strategies aiming to increase performance by: (i) having access to the pedometer web page that allows them to view their automatically calculated goals, and get feedback about performance toward goals

Outcome Measures

Primary Outcome Measures :
  1. Quality of Life (CHEQOL-25) [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ages of 8 - 14 years
  • has epilepsy, as confirmed by a pediatric neurologist with at least 1 seizures in the previous 12 months
  • must be ambulatory; (iv) understands English or French
  • functions at a grade 3 level as judged by parents
  • not involved in regular competitive physical sports
  • able and willing to complete the web-based questionnaires.

Exclusion Criteria:

  • anyone not between ages of 8 and 14
  • patient must have epilepsy
  • unable to walk
  • non english or french speaking
  • functioning below a grade 3 level
  • already involved in regular physical activity
  • unable to complete web-based questionnaires
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550874

Contact: Gabriel M Ronen, MD 905-521-2100 ext 73392 roneng@mcmaster.ca
Contact: Sarah L Mitchell 905-521-2100 ext 73392 smitch@mcmaster.ca

Canada, Ontario
McMaster Children's Hospital Recruiting
Hamilton, Ontario, Canada, L8S 4K1
Contact: Gabriel M Ronen, MD    905-521-2100 ext 73392    roneng@mcmaster.ca   
Contact: Helena Viveiros       viveiro@mcmaster.ca   
Principal Investigator: Ronen M. Ronen, MD         
Sub-Investigator: Brian Timmons, PHD         
Sub-Investigator: David Streiner, PHD         
Sub-Investigator: Steven Bray, PHD         
Sub-Investigator: Peter Rosenbaum, MD         
Children's Hospital of Eastern Ontario Active, not recruiting
Ottawa, Ontario, Canada, K1H 8L1
Sponsors and Collaborators
McMaster University
Principal Investigator: Gabriel M Ronen, MD McMaster University
More Information

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01550874     History of Changes
Other Study ID Numbers: REB 12-035
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by McMaster University:
Physical Activity

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms