Diplegic Spastic Cerebral PalsyNCT06752226
Effect of AO Training on Gross Motor Function in Children with Spastic Cerebral Palsy
A study testing action observation trainingAOT refers to an observational practice that has been used extensively for the goal of motor programming and enhances motor learning and performance in people with Diplegic Spastic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
The study was conducted to examine the impact of the action observation training (AOT) on gross motor function in children with spastic cerebral palsy. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Diplegic Spastic Cerebral Palsy
- What is being tested?
- action observation trainingAOT refers to an observational practice that has been used extensively for the goal of motor programming and enhances motor learning and performance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 27 May 2023to 4 Feb 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 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ranges from 4 - 7 years. Level Ι - Π according to Gross Motor Functional Classification System (GMFCS) (Appendix II).
- Grade 1, +1 and 2 of the Modified Ashworth Scale (Appendix III). Able to follow verbal commands and instructions.
Who cannot join
- Significant visual or auditory impairments Structural or fixed soft tissue deformities of Lower extremities. Perception disorders. Botox injection in the lower extremity in the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Action Observation Training on Gross Motor Function in Children with Spastic Cerebral Palsy
The study was conducted to examine the impact of the action observation training (AOT) on gross motor function in children with spastic cerebral palsy.
Read the detailed description
Thirty children with spastic diplegic cerebral palsy aged from 4 to 7 years were randomly allocated into two groups of equal number; study group (A) and control group (B). Both groups received designed physical therapy program for 45 minutes, three times/ per week for two successive months. In addition, study group received action observation (AO) training for 30 minutes per session. All phases of gait cycle and functional ability of all children participating in both groups was assessed by kenovia software and gross motor function measure (GMFM) walking, running and jumping domain.
- Conditions
- Diplegic Spastic Cerebral Palsy
- Being tested
- action observation trainingAOT refers to an observational practice that has been used extensively for the goal of motor programming and enhances motor learning and performance
- Medical subject headings
- Cerebral palsy, spastic, diplegic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
action observation trainingAOT refers to an observational practice that has been used extensively for the goal of motor programming and enhances motor learning and performanceOther
In AOT, motor-related information can be available through the visual function by encoding into the mental representation of the memory to organize the intended action
| Study group | Role | What they receive |
|---|---|---|
| Effect of action observation training on gross motor function in children with cerebral palsy | Experimental | Action observation training used to improve gross motor function including walking, jumping and running domain in children with cerebral palsy by observing at imitate phases of gait cycle performed by a normal person Receives: Other: action observation trainingAOT refers to an observational practice that has been used extensively for the goal of motor programming and enhances motor learning and performance |
| action observation training | Experimental | Action observation training (AO) is cognitive intervention technique that is used to improve and learn exercise skills in sports, athletes, the general public and patient with motor impairment Receives: Other: action observation trainingAOT refers to an observational practice that has been used extensively for the goal of motor programming and enhances motor learning and performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
- Gross Motor Function Measure All children were assessed using the GMFM-88 scale. The GMFM scale has been validated to assess change in motor performance in children with CP. In this study we assessed the items of walking, running and jumping of the GMFM. The items are scored on four-point ordinal scales (0=cannot initiate; 1=initiates; 2=partially completes item; 3=completes item independently)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start27 May 2023
- Primary completion16 Nov 2023
- Study completion4 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diplegic Spastic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- parallel study is a type of clinical study in which two or more groups of participations receive different interventions
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekram magdy Mohamed fadl, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752226
- Sponsor's protocol ID
- exercises on motor function
- Status last verified
- Dec 2024
- First submitted
- 21 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Action Observation Training on Gross Motor Function in Children with Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06752226
- Acronym / sponsor ID
- exercises on motor function
- Conditions
- Diplegic Spastic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 27 May 2023 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 4 Feb 2024 (actual)
- First posted
- 30 Dec 2024 (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.
The study was conducted to examine the impact of the action observation training (AOT) on gross motor function in children with spastic cerebral palsy.
Detailed description
Thirty children with spastic diplegic cerebral palsy aged from 4 to 7 years were randomly allocated into two groups of equal number; study group (A) and control group (B). Both groups received designed physical therapy program for 45 minutes, three times/ per week for two successive months. In addition, study group received action observation (AO) training for 30 minutes per session. All phases of gait cycle and functional ability of all children participating in both groups was assessed by kenovia software and gross motor function measure (GMFM) walking, running and jumping domain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- parallel study is a type of clinical study in which two or more groups of participations receive different interventions
| Arm | Type | Receives |
|---|---|---|
| Effect of action observation training on gross motor function in children with cerebral palsy | Experimental | Other: action observation trainingAOT refers to an observational practice that has been used extensively for the goal of motor programming and enhances motor learning and performanceAction observation training used to improve gross motor function including walking, jumping and running domain in children with cerebral palsy by observing at imitate phases of gait cycle performed by a normal person |
| action observation training | Experimental | Other: action observation trainingAOT refers to an observational practice that has been used extensively for the goal of motor programming and enhances motor learning and performanceAction observation training (AO) is cognitive intervention technique that is used to improve and learn exercise skills in sports, athletes, the general public and patient with motor impairment |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age ranges from 4 - 7 years. Level Ι - Π according to Gross Motor Functional Classification System (GMFCS) (Appendix II).
- Grade 1, +1 and 2 of the Modified Ashworth Scale (Appendix III). Able to follow verbal commands and instructions.
Key exclusion criteria (1 listed)
- Significant visual or auditory impairments Structural or fixed soft tissue deformities of Lower extremities. Perception disorders. Botox injection in the lower extremity in the past 6 months.
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 trainingAOT refers to an observational practice that has been used extensively for the goal of motor programming and enhances motor learning and performanceIn AOT, motor-related information can be available through the visual function by encoding into the mental representation of the memory to organize the intended action | Other | Effect of action observation training on gross motor function in children with cerebral palsy, action observation training |
Primary outcome
Primary Outcome Measure
Time frame: 8 weeks
1. Gross Motor Function Measure All children were assessed using the GMFM-88 scale. The GMFM scale has been validated to assess change in motor performance in children with CP. In this study we assessed the items of walking, running and jumping of the GMFM. The items are scored on four-point ordinal scales (0=cannot initiate; 1=initiates; 2=partially completes item; 3=completes item independently)
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 30 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Dual-Task Training in Children With Spastic Diplegic Cerebral Palsy
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Sleep Quality, Caregiver Burden, Stress, and Self-Efficacy in Parents of Children With Spastic Diplegic Cerebral Palsy: A Comparison by Night Orthosis Use
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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 trainingAOT refers to an observational practice that has been used extensively for the goal of motor programming and enhances motor learning and performance in people with Diplegic Spastic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
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 2 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 30 Dec 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 Egypt. 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?
Primary Outcome Measure (time frame: 8 weeks). 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 30 Dec 2024.