- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07466147
The Effect of Playful Physiotherapy Intervention
The Effect of Playful Physiotherapy Intervention on Emotional Self-regulation in Children Aged 7-12 Years Old With Neurodevelopmental and Behavioral Special Needs in a Rehabilitation Setting.
The goal of this quasi-experimental study is to evaluate the changes in emotional, behavioral, and psychosocial functioning of children aged 7-12 following a playful physiotherapy intervention. The study focused on the potential effects of a play- and body-based intervention on children's daily functioning, based on parent-reported assessments
The main question[s] it aims to answer [is/are]:
Participants will be evaluated based on the Strengths and Difficulties Questionnaire and KIDSCREEN-27 before and after the playful physiotherapy intervention programme.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hanna Kalajas-Tilga, PhD
- Phone Number: +37258361041
- Email: h9kala@gmail.com
Study Locations
-
-
-
Tartu, Estonia
- Recruiting
- ProVida
-
Contact:
- Ingrid Tiirats
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 5-12 years;
- Clinical diagnosis: ADHD, ASD, behavioral regulation difficulties, and/or social adaptation difficulties in group settings;
- Participation in physiotherapy at ProVida Clinic or assessment by the clinic's rehabilitation team regarding suitability for participation;
- Ability to participate in movement- and play-based activities in a group format;
- Proficiency in Estonian;
- No prior participation in a similar group.
Exclusion Criteria:
- Acute or chronic medical condition that prevents active participation;
- Severe cognitive or sensory impairment that prevents understanding of activities or safe participation;
- Situations in which the child's participation may disrupt group functioning or compromise safety.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
|
Experimental: Intervention group
|
Subjects will attend playful physiotherapy sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life of the participants
Time Frame: Baseline and to the end of the intervention at 6 weeks
|
Quality of life of the participants is evaluated by their parents using KIDSCREEN-27
|
Baseline and to the end of the intervention at 6 weeks
|
|
Positive and negative aspects of psychosocial functioning of the participants
Time Frame: Baseline and to the end of the intervention at 6 weeks
|
Positive and negative aspects of participants' psychosocial functioning is evaluated bu their parents using SDQ scale.
|
Baseline and to the end of the intervention at 6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VaimseterviseFT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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