- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06942364
Action Observation Therapy in Hemiparetic CP: Impact on Balance & Lower Limb Function
The Effect of Action Observation Therapy on Balance and Lower Extremity Function in Children With Hemiparetic Cerebral Palsy
Background:
Action Observation Therapy (AOT) leverages the mirror neuron system to enhance motor learning and is anticipated to improve upper extremity function in children with cerebral palsy. However, its effects on balance, lower extremity function, and gait performance in children with hemiparetic cerebral palsy remain underexplored. The planned study aims to evaluate whether the addition of AOT to conventional physiotherapy will positively influence balance, lower extremity function, and gait performance in this population.
Objective:
The study is designed to assess the efficacy of incorporating AOT as an adjunct to conventional physiotherapy in improving balance, lower extremity function, and gait performance in children with hemiparetic cerebral palsy.
Methods:
A patient cohort consisting of children with hemiparetic cerebral palsy (GMFCS levels I and II) is planned to be assembled.
It is expected that a total of 20 patients will be recruited and then randomly allocated into an experimental group and a control group.
The experimental group is scheduled to receive conventional physiotherapy in addition to AOT sessions, while the control group is planned to receive conventional physiotherapy only.
The intervention period is planned for 6 weeks, during which both groups will participate in 12 physiotherapy sessions.
Additionally, the experimental group is scheduled to undergo AOT sessions twice weekly, with each session lasting 30 minutes.
Outcome measures to be employed will include the Timed Up and Go (TUG) test, Pediatric Balance Scale, Five-Step Stair Climbing and Descending Test, and the 6-Minute Walk Test (6MWT).
This study is expected to systematically evaluate the potential benefits of adding AOT to standard physiotherapy regimens for enhancing balance, lower extremity function, and gait performance in children with hemiparetic cerebral palsy.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kınıklı
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Denizli, Kınıklı, Turkey, 20070
- Pamukkale University Faculty of Physiotherapy and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed hemiparetic type of cerebral palsy
Exclusion Criteria:
- Any other types of cerebral palsy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: control
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Conventional physiotherapy is a widely used therapeutic approach that focuses on improving physical function, mobility, and overall quality of life through evidence-based techniques.
It typically includes exercises for strength, flexibility, balance, and coordination, along with manual therapy, postural training, and education about movement and body mechanics.
This traditional method is commonly applied in the rehabilitation of patients with neurological, orthopedic, and musculoskeletal conditions.
In pediatric populations, such as children with cerebral palsy, conventional physiotherapy plays a vital role in promoting motor development, enhancing functional independence, and preventing secondary complications.
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Experimental: experimental
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The AOT video comprised four specific tasks designed to improve lower extremity function, balance, and gait (Figure 1):
Conventional physiotherapy is a widely used therapeutic approach that focuses on improving physical function, mobility, and overall quality of life through evidence-based techniques.
It typically includes exercises for strength, flexibility, balance, and coordination, along with manual therapy, postural training, and education about movement and body mechanics.
This traditional method is commonly applied in the rehabilitation of patients with neurological, orthopedic, and musculoskeletal conditions.
In pediatric populations, such as children with cerebral palsy, conventional physiotherapy plays a vital role in promoting motor development, enhancing functional independence, and preventing secondary complications.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go Test
Time Frame: This test will be administered twice: once before and once after a 6-week intervention period comprising a total of 12 sessions.
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The Timed Up and Go (TUG) Test is a simple and widely used clinical tool to assess a person's mobility, balance, and risk of falling.
It involves timing a person as they rise from a standard chair, walk a distance of 3 meters, turn around, walk back to the chair, and sit down.
The total time taken to complete this sequence is recorded, with shorter times generally indicating better functional mobility.
The TUG Test is commonly used in various populations, including older adults and individuals with neurological conditions such as stroke or cerebral palsy, to evaluate progress during rehabilitation or to identify individuals at risk of falls.
It is valued for its ease of use, minimal equipment requirements, and ability to reflect real-world functional movements.
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This test will be administered twice: once before and once after a 6-week intervention period comprising a total of 12 sessions.
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Pediatric Balance Scale
Time Frame: This test will be administered twice: once before and once after a 6-week intervention period comprising a total of 12 sessions.
|
A modified version of the Berg Balance Scale for children, the PBS consists of 14 items (maximum score 56).
It assesses functional balance through activities such as sitting-to-standing, standing, transfers, stepping, single-leg stance, turning, bending, and reaching.
The scale has demonstrated strong correlations with other functional measures in children with CP
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This test will be administered twice: once before and once after a 6-week intervention period comprising a total of 12 sessions.
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Five-Step Stair Climbing and Descending Test
Time Frame: This test will be administered twice: once before and once after a 6-week intervention period comprising a total of 12 sessions.
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This test evaluates functional mobility parameters including walking speed, strength, active joint range, and balance.
Children are instructed to ascend and descend a 5-step staircase without pausing.
The better of two trials is recorded; a shorter completion time indicates superior functional performance
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This test will be administered twice: once before and once after a 6-week intervention period comprising a total of 12 sessions.
|
|
6-Minute Walk Test
Time Frame: This test will be administered twice: once before and once after a 6-week intervention period comprising a total of 12 sessions.
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Originally developed by Balke (1963), the 6MWT measures the distance walked in 6 minutes, reflecting the child's functional capacity for daily activities.
In children with CP, typical distances range from 334 to 455 meters, varying according to sex, age, height, weight, and step length
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This test will be administered twice: once before and once after a 6-week intervention period comprising a total of 12 sessions.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Action Observation Therapy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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