Hemiparetic Cerebral Palsy ChildrenNCT06942364
Action Observation Therapy in Hemiparetic CP: Impact on Balance & Lower Limb Function
A study testing Action Observation Therapy and conventional physiotherapy in people with Hemiparetic Cerebral Palsy Children, run by Fatih Tekin at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Hemiparetic Cerebral Palsy Children
- What is being tested?
- Action Observation Therapy and conventional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2023to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed hemiparetic type of cerebral palsy
Who cannot join
- Any other types of cerebral palsy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University Faculty of Physiotherapy and Rehabilitation
Denizli, Kınıklı, 20070
About this study
Official title: 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.
Read more
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.
- Conditions
- Hemiparetic Cerebral Palsy Children
- Being tested
- Action Observation Therapy, conventional physiotherapy
- Keywords
- Action Observation Therapy, Hemiparetic Cerebral Palsy, Balance, Lower Extremity Function, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action Observation TherapyOther
The AOT video comprised four specific tasks designed to improve lower extremity function, balance, and gait (Figure 1):
- Sitting Balance: Movements to enhance balance while seated (Figure 2).
- Sit-to-Stand Transition: Exercises to facilitate the transition from sitting to standing.
- Walking and Balance: Gait and balance training on a parallel bar or flat surface.
- Single-Leg Balance: Activities focused on improving balance on one leg. For each task, children observed the movement for 1 minute, then practiced the action for 5 minutes. A 1-minute rest period was allowed between tasks, with a total AOT session lasting 30 minutes. All sessions were conducted by the same physiotherapist.
conventional physiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Not described Receives: Other: Action Observation Therapy; Other: conventional physiotherapy |
| control | Active comparator | Not described Receives: Other: conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go Test
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.
Measured: This test will be administered twice: once before and once after a 6-week intervention period comprising a total of 12 sessions.
Pediatric Balance Scale
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
Measured: This test will be administered twice: once before and once after a 6-week intervention period comprising a total of 12 sessions.
Five-Step Stair Climbing and Descending Test
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
Measured: 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
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
Measured: This test will be administered twice: once before and once after a 6-week intervention period comprising a total of 12 sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start10 Jan 2023
- Primary completion10 Jun 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiparetic Cerebral Palsy ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The discovery of the mirror neuron system's role in motor learning has led to the development of Action Observation Therapy (AOT). In AOT, patients observe a video of specific movements or watch an instructor perform actions, then attempt to imitate them. This rehabilitation strategy is designed to repair damaged neural networks and re-establish motor function in individuals with central nervous system lesions. While several studies have shown that AOT can improve upper extremity function and reaching performance in children with CP, there is limited evidence regarding its effects on lower extremity function. Notably, no studies from our country have investigated the impact of AOT on balance and lower extremity function in children with CP.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Tekin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fatih Tekin, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942364
- Sponsor's protocol ID
- Action Observation Therapy
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Action Observation Therapy on Balance and Lower Extremity Function in Children With Hemiparetic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06942364
- Acronym / sponsor ID
- Action Observation Therapy
- Conditions
- Hemiparetic Cerebral Palsy Children
- Keywords
- Action Observation Therapy, Hemiparetic Cerebral Palsy, Balance, Lower Extremity Function, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fatih TekinUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The discovery of the mirror neuron system's role in motor learning has led to the development of Action Observation Therapy (AOT). In AOT, patients observe a video of specific movements or watch an instructor perform actions, then attempt to imitate them. This rehabilitation strategy is designed to repair damaged neural networks and re-establish motor function in individuals with central nervous system lesions. While several studies have shown that AOT can improve upper extremity function and reaching performance in children with CP, there is limited evidence regarding its effects on lower extremity function. Notably, no studies from our country have investigated the impact of AOT on balance and lower extremity function in children with CP.
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Other: Action Observation Therapy, Other: conventional physiotherapy |
| control | Active comparator | Other: conventional physiotherapy |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Diagnosed hemiparetic type of cerebral palsy
Key exclusion criteria (1 listed)
- Any other types of cerebral palsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action Observation TherapyThe AOT video comprised four specific tasks designed to improve lower extremity function, balance, and gait (Figure 1): 1. Sitting Balance: Movements to enhance balance while seated (Figure 2). 2. Sit-to-Stand Transition: Exercises to facilitate the transition from sitting to standing. 3. Walking and Balance: Gait and balance training on a parallel bar or flat surface. 4. Single-Leg Balance: Activities focused on improving balance on one leg. For each task, children observed the movement for 1 minute, then practiced the action for 5 minutes. A 1-minute rest period was allowed between tasks, with a total AOT session lasting 30 minutes. All sessions were conducted by the same physiotherapist. | Other | experimental |
| conventional physiotherapyConventional 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. | Other | control, experimental |
Primary outcome
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.
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.
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
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.
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
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Hemiparetic Cerebral Palsy Children
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Effect of Robotic Gloves Training on Upper Limb Coordination, Selective Motor Control and Activities of Daily Living in Children With Hemiparetic Cerebral Palsy
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Mirror Therapy in Children With Hemiparetic Cerebral Palsy
Hemiplegic Cerebral Palsy, Mirror Hands
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Effect of Reciprocal Electrical Stimulation on Balance and Quality of Life in Hemiparetic CP
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Effect of Blood Flow Restriction Training Exercises on Hand Grip Strength in Hemiparetic Cerebral Palsied Children
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action Observation Therapy and conventional physiotherapy in people with Hemiparetic Cerebral Palsy Children, run by Fatih Tekin at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.