- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05951829
Effects of Action Observation Therapy and Mirror Therapy in Children With Unilateral Cerebral Palsy
July 10, 2023 updated by: SEDANUR GÜRLEK, Hacettepe University
Effects of Action Observation Therapy and Mirror Therapy on Upper Extremity Functions in Children With Unilateral Cerebral Palsy: A Randomized Controlled Study With 1 Month Follow-Up
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).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Cerebral Palsy
|
Action Observation Therapy Mirror Therapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Canadian Occupational Performance Measure
Time Frame: 6 weeks
|
Assessment
|
6 weeks
|
|
Goal Attainment Scaling
Time Frame: 6 weeks
|
Assessment
|
6 weeks
|
|
Shriners Hospital Upper Extremity Evaluation
Time Frame: 6 weeks
|
Assessment
|
6 weeks
|
|
Melbourne Assessment of Unilateral Upper Limb Function
Time Frame: 6 weeks
|
Assessment
|
6 weeks
|
|
ABILHAND-Kids Questionnaire
Time Frame: 6 weeks
|
Assessment
|
6 weeks
|
|
Visual Analogue Scale
Time Frame: 6 weeks
|
Assessment
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 10, 2023
Primary Completion (Estimated)
January 10, 2025
Study Completion (Estimated)
January 15, 2025
Study Registration Dates
First Submitted
June 21, 2023
First Submitted That Met QC Criteria
July 10, 2023
First Posted (Actual)
July 19, 2023
Study Record Updates
Last Update Posted (Actual)
July 19, 2023
Last Update Submitted That Met QC Criteria
July 10, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SG13
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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