Effects of Action Observation Therapy and Mirror Therapy... | NCT05951829

Studies
Effects of Action Observation Therapy and Mirror Therapy in Children With Unilateral Cerebral Palsy

NCT05951829

Sponsor

Hacettepe University

Status

Unknown status

Last Update Posted

Jul 19, 2023Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Cerebral Palsy
Functioning
Upper Extremity Problem

Interventions

Action Observation Therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2023Estimated

Primary Completion Date

Jan 10, 2025Estimated

Completion Date

Jan 15, 2025Estimated

First Submitted Date

Jun 21, 2023

First Submission Date that Met QC Criteria

Jul 10, 2023

First Posted Date

Jul 19, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2023

Last Update Posted Date

Jul 19, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

SEDANUR GÜRLEK, Hacettepe University-Principal Investigator-PhD Student, Hacettepe UniversityPrincipal Investigator

Lead Sponsor

Hacettepe UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study was to examine the effects of action observation therapy and mirror therapy on upper extremity functions in children with unilateral cerebral palsy. In the study, the 1st group is the Action Observation Therapy group and will receive 18 sessions of practice. The second group is the mirror therapy group and will receive a total of 18 practice sessions. To evaluate the outcome measures of children's upper extremity functions; Canadian Occupational Performance Mesure (COPM), Goal Achievement Scale (GAS), Shriners Hospital Upper Extremity Function Scale (SHUEE), Melbourne Unilateral Upper Extremity Function Evaluation Test and ABILHAND Questionnaire will be used. The satisfaction of the families with the therapy process will be evaluated with the Visual Analog Scale (VAS).

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cerebral Palsy	Other		Other: Action Observation Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Action Observation Therapy	Other	Action Observation Therapy Mirror Therapy	Cerebral Palsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Canadian Occupational Performance Measure	Assessment	6 weeks
Goal Attainment Scaling	Assessment	6 weeks
Shriners Hospital Upper Extremity Evaluation	Assessment	6 weeks
Melbourne Assessment of Unilateral Upper Limb Function	Assessment	6 weeks
ABILHAND-Kids Questionnaire	Assessment	6 weeks
Visual Analogue Scale	Assessment	6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Being between the ages of 5 and 15
Being diagnosed with unilateral cerebral palsy
Be in one of the levels 1,2 and 3 according to the MACS dexterity classification
Upper extremity Modified Ashworth Scale score less than or equal to 2 attending primary school

Exclusion Criteria:

Having a visual impairment recorded in the health report
To have any neurological, orthopedic, and psychiatric diagnosis in addition to the diagnosis of cerebral palsy
Difficulty understanding and applying verbal and visual commands
To have undergone any surgical intervention or botox in the last 3 months

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42339598	Derived	Gurlek S, Bumin G, Adar S. Effects of Action Observation and Mirror Therapy on Upper Extremity Functions in Unilateral Cerebral Palsy: A Randomized Controlled Trial. Phys Occup Ther Pediatr. 2026 Jun 24:1-24. doi: 10.1080/01942638.2026.2691064. Online ahead of print.

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D026741	Physical Therapy Modalities
D012046	Rehabilitation
D013812	Therapeutics