Diplegic Cerebral PalsyNCT05209282
Diplegic Cerebral Palsy and Action Observation Training
A study testing Video Based Action Observation, Live Action Observation and Conventional physiotherapy program in people with Diplegic Cerebral Palsy, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
In this study, video-based action observation training and live action observation training in children with spastic diplegic cerebral palsy; It was aimed to examine the effect on motor function, activity participation and secondary outcome measures. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Diplegic Cerebral Palsy
- What is being tested?
- Video Based Action Observation, Live Action Observation and Conventional physiotherapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 31 Oct 2022
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being diagnosed with spastic diplegic cerebral palsy,
- To be between the ages of 5-14,
- To be at GMFCS I, II and III levels,
- To have the cognitive level to follow the instructions given by the researchers,
- IQ> 70 (to be accessed from patient files),
- Those who do not have serious restrictions in joint movement,
Who cannot join
- Children with joint contractures,
- Not having visual impairment and visual field defect,
- Children who have had a seizure in the last 6 months or children who cannot be controlled despite seizure medication
- Those who received botulinum injections 6 months before the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University
Malatya, Battalgazi/MALATYA, 44280
About this study
Official title: The Effect Of Video Based Action Observation Training And Live Action Observation Training On Motor Function, Activity Participation And Secondary Outcome Measures İn Children With Spastic Diplegic Cerebral Palsy
In this study, video-based action observation training and live action observation training in children with spastic diplegic cerebral palsy; It was aimed to examine the effect on motor function, activity participation and secondary outcome measures.
Read the detailed description
The study was designed as a single-blind randomized controlled trial. Patients aged 5-14 years with spastic diplegic cerebral palsy will be included. Children will be assigned to groups through stratified randomisation; The patients will be divided into 3 groups as experimental and control groups. Group 1 (experiment): video-based action observation training in addition to the conventional rehabilitation program, Group 2 (experiment): live action observation training in addition to the conventional rehabilitation program, Group 3 (control) will receive only the conventional rehabilitation program. The experimental group will receive 20 minutes of action observation training after a conventional physiotherapy program for 20 minutes for 8 weeks, 40 minutes 2 days a week. The control group will receive 40 minutes of conventional treatment. Evaluations will be made for each group, before and 8 weeks after the start of the study. GMFM for gross motor function; Pediatric berg balance scale for balance function; Timed Up and Go Test for functional mobility assessment; Gillette Functional Assessment Questionnaire and 1-min walk test to assess functional walking; sit and stand test for functional muscle strength and to evaluate activity participation; The Child and Adolescent Participation Questionnaire (CASP) will be used.
- Conditions
- Diplegic Cerebral Palsy
- Being tested
- Video Based Action Observation, Live Action Observation, Conventional physiotherapy program
- Keywords
- Action Observation Therapy, Diplegic Cerebral Palsy, Mirror Neuron System, Motor Function, Activity Participation, Secondary Outcome Measures
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Based Action ObservationOther
Also called Conventional physiotherapy program
Individuals in this group will receive video-based action observation training in addition to the conventional physiotherapy program.
Live Action ObservationOther
Also called Conventional physiotherapy program
Individuals in this group will receive live action observation training in addition to the conventional physiotherapy program.
Conventional physiotherapy programOther
Individuals in this group will only receive a conventional physiotherapy program.
| Study group | Role | What they receive |
|---|---|---|
| Grup I | Experimental | Conventional physiotherapy program, Video-based action observation training Receives: Other: Video Based Action Observation; Other: Conventional physiotherapy program |
| Grup II | Experimental | Conventional physiotherapy program, Live Action Observation Training Receives: Other: Live Action Observation; Other: Conventional physiotherapy program |
| Grup III | Other | Conventional physiotherapy program Receives: Other: Conventional physiotherapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure
Gross Motor Function measure is used to evaluate Motor Functions
Measured: 8weeks
The Child and Adolescent Scale of Participation (CASP)
The CASP questionnaire is a questionnaire that evaluates the individual's community participation in the home, school, neighborhood settings.
Measured: 8weeks
Secondary outcomes (5)
Pediatric berg balance scale
The test is performed progressively from timed sitting balance to standing on one leg.
Measured: 8weeks
Timed Up and Go Test (TUG)
It is a test that measures the mobility of the child and evaluates both dynamic and static balance.
Measured: 8weeks
Gillette Functional Assessment Questionnaire
Gillette FDA is a self-reported or self-reported assessment. Gillette FDA; It includes the FDA Gait Scale, which classifies ambulation function at 10 levels, and the 22-item Skills Test assessing functional locomotor activity.
Measured: 8weeks
One-Minute Walk Test
It is an inexpensive and user-friendly test that can be used to assess functional ability with the 1-minute fast walking test. During the test, children wear their comfortable clothes and shoes. Children who wear orthoses are evaluated with orthoses, and children who walk with a mobility aid are evaluated with mobility aids.
Measured: 8weeks
Sit to Stand Test
The child is asked to get up from a chair without armrests and sit back down again, with his hips and knees flexed to 90 degrees and his feet in full contact with the ground. The time to sit and stand up to 5 times is determined by the stopwatch.
Measured: 8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Jan 2022
- Primary completion24 Feb 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diplegic Cerebral PalsyStudies 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
- Experimental, Randomized Controlled Study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Talu, Inonu University
- Investigators
- Burcu TALU, Assoc. Prof., Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209282
- Sponsor's protocol ID
- 2021/2663
- Status last verified
- Apr 2023
- First submitted
- 13 Jan 2022
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Video Based Action Observation Training And Live Action Observation Training On Motor Function, Activity Participation And Secondary Outcome Measures İn Children With Spastic Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05209282
- Acronym / sponsor ID
- 2021/2663
- Conditions
- Diplegic Cerebral Palsy
- Keywords
- Action Observation Therapy, Diplegic Cerebral Palsy, Mirror Neuron System, Motor Function, Activity Participation, Secondary Outcome Measures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 24 Feb 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 26 Jan 2022 (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.
In this study, video-based action observation training and live action observation training in children with spastic diplegic cerebral palsy; It was aimed to examine the effect on motor function, activity participation and secondary outcome measures.
Detailed description
The study was designed as a single-blind randomized controlled trial. Patients aged 5-14 years with spastic diplegic cerebral palsy will be included. Children will be assigned to groups through stratified randomisation; The patients will be divided into 3 groups as experimental and control groups. Group 1 (experiment): video-based action observation training in addition to the conventional rehabilitation program, Group 2 (experiment): live action observation training in addition to the conventional rehabilitation program, Group 3 (control) will receive only the conventional rehabilitation program. The experimental group will receive 20 minutes of action observation training after a conventional physiotherapy program for 20 minutes for 8 weeks, 40 minutes 2 days a week. The control group will receive 40 minutes of conventional treatment. Evaluations will be made for each group, before and 8 weeks after the start of the study. GMFM for gross motor function; Pediatric berg balance scale for balance function; Timed Up and Go Test for functional mobility assessment; Gillette Functional Assessment Questionnaire and 1-min walk test to assess functional walking; sit and stand test for functional muscle strength and to evaluate activity participation; The Child and Adolescent Participation Questionnaire (CASP) will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Experimental, Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Grup I | Experimental | Other: Video Based Action Observation, Other: Conventional physiotherapy programConventional physiotherapy program, Video-based action observation training |
| Grup II | Experimental | Other: Live Action Observation, Other: Conventional physiotherapy programConventional physiotherapy program, Live Action Observation Training |
| Grup III | Other | Other: Conventional physiotherapy programConventional physiotherapy program |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Being diagnosed with spastic diplegic cerebral palsy,
- To be between the ages of 5-14,
- To be at GMFCS I, II and III levels,
- To have the cognitive level to follow the instructions given by the researchers,
- IQ> 70 (to be accessed from patient files),
Key exclusion criteria (4 listed)
- Children with joint contractures,
- Not having visual impairment and visual field defect,
- Children who have had a seizure in the last 6 months or children who cannot be controlled despite seizure medication
- Those who received botulinum injections 6 months before the study.
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 |
|---|---|---|
| Video Based Action ObservationAlso: Conventional physiotherapy programIndividuals in this group will receive video-based action observation training in addition to the conventional physiotherapy program. | Other | Grup I |
| Live Action ObservationAlso: Conventional physiotherapy programIndividuals in this group will receive live action observation training in addition to the conventional physiotherapy program. | Other | Grup II |
| Conventional physiotherapy programIndividuals in this group will only receive a conventional physiotherapy program. | Other | Grup I, Grup II, Grup III |
Primary outcome
Gross Motor Function Measure
Time frame: 8weeks
Gross Motor Function measure is used to evaluate Motor Functions
The Child and Adolescent Scale of Participation (CASP)
Time frame: 8weeks
The CASP questionnaire is a questionnaire that evaluates the individual's community participation in the home, school, neighborhood settings.
5 secondary outcomes
Pediatric berg balance scale
Time frame: 8weeks
Timed Up and Go Test (TUG)
Time frame: 8weeks
Gillette Functional Assessment Questionnaire
Time frame: 8weeks
One-Minute Walk Test
Time frame: 8weeks
Sit to Stand Test
Time frame: 8weeks
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 9 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Diplegic Cerebral Palsy
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Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
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Dual-Task Training in Children With Spastic Diplegic Cerebral Palsy
Spastic Diplegia Cerebral Palsy
Not yet recruitingObservational study
Sleep Quality, Caregiver Burden, Stress, and Self-Efficacy in Parents of Children With Spastic Diplegic Cerebral Palsy: A Comparison by Night Orthosis Use
Cerebral Palsy, Sleep Disorders
Recruiting
Effects of Transcranial Direct Current Stimulation Combined With Virtual Reality on Gait and Self-Esteem in Children With Spastic Cerebral Palsy
Spastic Diplegic Cerebral Palsy
Recruiting
Effects of Transcranial Direct Current Stimulation Combined With Virtual Reality on Balance and Executive Functions in Children With Spastic Diplegic Cerebral Palsy
Spastic Diplegic Cerebral Palsy
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.
Burcu TALU, Assoc. Prof. principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Based Action Observation, Live Action Observation and Conventional physiotherapy program in people with Diplegic Cerebral Palsy, run by Inonu University 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 6 inclusion and 4 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 9 Feb 2024. 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?
Gross Motor Function Measure (time frame: 8weeks). The study lists 2 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 9 Feb 2024.