An interventional study of Ayres Sensory Integration-Based Physiotherapy and Usual Physiotherapy and Rehabilitation in Cerebral Palsy (CP), sponsored by Izgi Miray Demirbag. Not yet recruiting. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Izgi Miray Demirbag · Not applicable, Interventional, and Treatment
This study will examine whether a 12-week Ayres Sensory Integration (ASI)-based physiotherapy program can improve motor skills and daily functioning in young children with cerebral palsy. Thirty children aged 3 to 6 years who meet the study criteria will be assigned to an intervention group or a control group.
Children in the intervention group will receive 36 sessions of ASI-based physiotherapy over 12 weeks. Each session will last 60 minutes and will be provided by a physiotherapist certified in ASI. Children in the control group will continue their usual physiotherapy and rehabilitation and will not receive additional ASI as part of the study.
Children will be assessed before and after the 12-week study period. Assessments will include measures of motor skills, development, daily activities, sensory processing, and progress toward individual goals. The Evaluation in Ayres Sensory Integration (EASI) will be completed before the intervention only. Assessments will be carried out in a clinical setting by an assessor who is independent of the therapists providing the intervention.
This study will evaluate the effectiveness of an Ayres Sensory Integration (ASI)-based physiotherapy intervention in children with cerebral palsy. Thirty children aged 3 to 6 years who meet the eligibility criteria will be assigned to an intervention group or a control group using age- and sex-stratified randomization.
Children in the intervention group will receive ASI-based physiotherapy from a physiotherapist who holds an ASI practitioner certificate. The intervention will last 12 weeks and will consist of three 60-minute sessions per week, for a total of 36 sessions. Children in the control group will continue their usual physiotherapy and rehabilitation. No additional ASI intervention will be provided to the control group as part of the study.
Demographic, perinatal, natal, and postnatal information will be collected using a researcher-developed Demographic Information Form. Before the intervention, sensory functions will be assessed using the Evaluation in Ayres Sensory Integration (EASI). The EASI will be administered at baseline only and will not be repeated after the intervention.
Sensory processing will be assessed using the family-report Sensory Processing Measure (SPM), which evaluates areas including social participation, vision, hearing, taste, smell, touch, movement, body awareness, and planning. Gross motor function will be assessed using the Gross Motor Function Measure-88 (GMFM-88). Individualized goals will be established at the start of the intervention in collaboration with the parents using the Goal Attainment Scale (GAS). The Peabody Developmental Motor Scales, Second Edition (PDMS-2), and the Pediatric Evaluation of Disability Inventory (PEDI) will be administered before and after the intervention. Assessments will be conducted in a clinical setting by an assessor independent of the intervention therapists.
1,894 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.
This study's planned enrollment of 30 is below the median of 34 across 1,396 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Izgi Miray Demirbag is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Children in this group will receive Ayres Sensory Integration (ASI)-based physiotherapy from a physiotherapist certified in ASI. The intervention will last 12 weeks and consist of three 60-minute sessions per week, for a total of 36 sessions. Each child will be expected to actively participate in individualized sensory-motor activities. Activities will be selected and adapted by the therapist to the child's abilities and needs and will encourage active, purposeful engagement.
Behavioral: Ayres Sensory Integration-Based Physiotherapy
Children in this group will continue their usual physiotherapy and rehabilitation care. They will not receive additional ASI-based physiotherapy as part of the study.
Behavioral: Usual Physiotherapy and Rehabilitation
A 12-week Ayres Sensory Integration-based physiotherapy program delivered by a physiotherapist certified in ASI. Children will attend three 60-minute sessions per week, for a total of 36 sessions. Each child will actively participate in individualized, purposeful sensory-motor activities selected and adapted by the therapist to the child's abilities and needs.
Children will continue the physiotherapy and rehabilitation care they usually receive. No additional Ayres Sensory Integration-based physiotherapy will be provided as part of the study.
Gross Motor Function Measure-88 (GMFM-88)
Gross motor function will be assessed using the Gross Motor Function Measure-88 (GMFM-88). The GMFM-88 assesses lying and rolling, sitting, crawling and kneeling, standing, and walking, running, and jumping. The total score will be recorded at baseline and at the end of the 12-week study period. Change from baseline to Week 12 will be compared between groups.
Time frame: Baseline and Week 12
Sensory Processing Measure (SPM)
Sensory processing will be assessed using the parent-report Sensory Processing Measure (SPM). Scores will be recorded at baseline and at the end of the 12-week study period. Change from baseline to Week 12 will be compared between groups.
Time frame: Baseline and Week 12
Peabody Developmental Motor Scales, Second Edition (PDMS-2)
Motor skills will be assessed using the Peabody Developmental Motor Scales, Second Edition (PDMS-2). Gross motor, fine motor, and total motor scores will be recorded at baseline and at the end of the 12-week study period. Changes from baseline to Week 12 will be compared between groups.
Time frame: Baseline and Week 12
Pediatric Evaluation of Disability Inventory (PEDI)
Functional skills will be assessed using the Pediatric Evaluation of Disability Inventory (PEDI), including self-care, mobility, and social function. Scores will be recorded at baseline and at the end of the 12-week study period. Change from baseline to Week 12 will be compared between groups.
Time frame: Baseline and Week 12
Goal Attainment Scale (GAS)
Individualized goals will be established in collaboration with the parents at the start of the intervention. Goal attainment will be assessed at the end of the 12-week study period using the Goal Attainment Scale. Each goal will be rated from -2 to +2, with 0 representing the expected level of attainment. The prespecified GAS score will be used for analysis.
Time frame: Goals established at baseline; goal attainment assessed at Week 12
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Apr 2027, 6 months later.
Of 882 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 6 months is below that.
Counting every sponsor, half of 900 studies reached it within 12 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.