Spastic DiplegiaAOT/CPNCT07651111
Action Observation Therapy in Children With Spastic Diplegia
A study testing A selected physical therapy program, Live action observation training (AOT) and Video action observation training (AOT) in people with Spastic Diplegia, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the effect of live versus video action observation training (AOT) on balance and gait in children with spastic diplegia. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Spastic Diplegia
- What is being tested?
- A selected physical therapy program, Live action observation training (AOT) and Video action observation training (AOT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Children of diplegia who walk by a crouch gait.
- The age of the selected children will range from 4 to 7 years old.
- Degree of spasticity will range from 1 to 1+, according to modified Ashworth scale (MAS).
- They will be selected as Level II according to Gross motor function classification system (GMFCS).
- They will be able to understand the tasks and researchers' instructions.
- Their heights are not less than 1 meter to be able to see the screen of the Biodex balance system.
Who cannot join
- Visual or auditory impairments.
- Vestibular impairments.
- Fixed deformities of the upper, lower limbs, and the spine.
- Botulinum toxin (Botox) injection for the last six months.
- Orthopedic surgeries in the last six months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mai Elsayed Abbass, PhD contact
Egypt1 site
Outpatient clinic of the Faculty of physical therapy, Cairo University
Giza, 12511
Esraa Elsayed Ali Elkiky, M.Sc, +20 10 92002696, esraa.elkiky@gmail.com
About this study
Official title: Effect of Live Versus Video Action Observation Training on Balance and Gait in Children With Spastic Diplegia
The aim of this study is to compare the effect of live versus video action observation training (AOT) on balance and gait in children with spastic diplegia.
Read the detailed description
Children with spastic diplegic often face difficulties with balance and walking, affecting their independence and quality of life. Because of the impact of reduced gait speed and other gait abnormalities on their participation and quality of life, the main focus of physical therapy interventions is to improve balance and gait of children with cerebral palsy (CP).
Action observation training is a developing rehabilitation based on mirror neurons that activate when one performs movements or observes the movements of others. It is applied to improve motor skills and learning in athletes, healthy people, and patients with motor disorders.
Although many studies have focused on the application of action observation training (AOT), especially in improving upper limb function in individuals with stroke or children with CP, there is still a lack of sufficient research examining its effects on spasticity, gross motor abilities, balance, and gait in children with CP.
There is one study comparing the effects of live and video forms of AOT on upper limb function in children with hemiparetic CP. The researchers found that live AOT was more effective than video AOT in improving upper limb performance.
To our knowledge, there are no previous studies that compare the effect of live and video forms of AOT on balance and gait in children with spastic diplegia. Addressing this gap may provide valuable insights into the optimal mode of AOT delivery for enhancing balance and gait.
- Conditions
- Spastic Diplegia
- Being tested
- A selected physical therapy program, Live action observation training (AOT), Video action observation training (AOT)
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A selected physical therapy programOther
Participants will receive a conventional physical therapy program, 3 sessions per week for 3 months. The program will include approximation exercises, balance training, functional activities (sit-to-stand, squatting, stair climbing), gait training with obstacles, walking exercises on different surfaces, and stretching exercises for the upper and lower limbs. The intervention aims to improve balance, mobility, coordination, and functional performance.
Live action observation training (AOT)Other
Participants will receive live AOT for 30 minutes, 3 times per week, for 3 months. Each task will involve 3 minutes of observing the therapist performing the activity, followed by 3 minutes of verbal guidance and 3 minutes of task execution by the child. A 1-minute rest period will be provided between tasks.
Video action observation training (AOT)Other
Participants will receive video-based AOT for 30 minutes, 3 times per week, for 3 months. They will observe task demonstrations presented on a computer screen from multiple viewing angles, followed by guided practice and task performance, similar to the live AOT protocol.
| Study group | Role | What they receive |
|---|---|---|
| A selected physical therapy program | Active comparator | Fifteen children will receive one hour of a selected physical therapy program, three times per week for 3 months. Receives: Other: A selected physical therapy program |
| A selected physical therapy program + Live action observation training (AOT) | Experimental | Fifteen children will receive 30 minutes of the same selected physical therapy program plus 30 minutes of live AOT, three times per week for 3 months. Receives: Other: A selected physical therapy program; Other: Live action observation training (AOT) |
| A selected physical therapy program + Video action observation training (AOT) | Experimental | Fifteen children will receive 30 minutes of the same selected physical therapy program plus 30 minutes of video AOT, three times per week for 3 months. Receives: Other: A selected physical therapy program; Other: Video action observation training (AOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Stability Index (OSI)
It will be assessed using the Biodex Balance System. Participants will stand on a dynamic platform at stability level 5 for three 30-second trials. The Overall Stability Index (OSI) will be recorded as a measure of postural stability in all directions. Lower OSI values indicate better balance control and greater postural stability.
Measured: 3 months
Anteroposterior Stability Index (APSI)
It will be measured using the Biodex Balance System during dynamic balance testing. APSI reflects the participant's ability to maintain balance in the forward and backward directions. Lower APSI scores indicate improved anteroposterior postural control.
Measured: 3 months
Mediolateral Stability Index (MLSI)
It will be assessed using the Biodex Balance System. MLSI evaluates the participant's ability to control balance in the side-to-side direction during dynamic standing. Lower MLSI values indicate better mediolateral stability and balance performance.
Measured: 3 months
Secondary outcomes (3)
Hip Flexion Angle
It will be assessed using Kinovea motion analysis software during gait. Reflective markers will be placed on anatomical landmarks, and participants will walk at a self-selected speed while being recorded with a high-definition camera. Hip flexion will be measured during the late swing phase, corresponding to peak hip flexion. Greater hip flexion angles toward normative values will indicate improved gait kinematics.
Measured: 3 months
Knee Flexion Angle
It will be evaluated using Kinovea software from recorded gait videos. Anatomical markers will be positioned on the greater trochanter, lateral femoral condyle, and lateral malleolus. Knee flexion will be measured during the terminal stance phase. Changes toward normal knee kinematics will be considered indicative of gait improvement.
Measured: 3 months
Ankle Dorsiflexion Angle
It will be measured using Kinovea software during gait analysis. Reflective markers placed on the lower limb and foot will be used to calculate ankle joint kinematics. Ankle dorsiflexion will be assessed at initial contact. Increased dorsiflexion toward normal gait values will indicate improved gait performance.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start20 Jun 2026 (estimated)
- Primary completion20 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic DiplegiaStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Elsayed Ali Hassan Elkiky, Cairo University
- Investigators
- Eman Ibrahem El-Hadidy, PhD, Study chair, Professor, Cairo universityMai Elsayed Abbass, PhD, Study director, Ass. Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651111
- Sponsor's protocol ID
- P.T.REC/012/006208
- Acronym
- AOT/CP
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Live Versus Video Action Observation Training on Balance and Gait in Children With Spastic Diplegia
- ClinicalTrials.gov ID
- NCT07651111
- Acronym / sponsor ID
- AOT/CP / P.T.REC/012/006208
- Conditions
- Spastic Diplegia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jun 2026 (estimated)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 16 Jun 2026 (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 aim of this study is to compare the effect of live versus video action observation training (AOT) on balance and gait in children with spastic diplegia.
Detailed description
Children with spastic diplegic often face difficulties with balance and walking, affecting their independence and quality of life. Because of the impact of reduced gait speed and other gait abnormalities on their participation and quality of life, the main focus of physical therapy interventions is to improve balance and gait of children with cerebral palsy (CP).
Action observation training is a developing rehabilitation based on mirror neurons that activate when one performs movements or observes the movements of others. It is applied to improve motor skills and learning in athletes, healthy people, and patients with motor disorders.
Although many studies have focused on the application of action observation training (AOT), especially in improving upper limb function in individuals with stroke or children with CP, there is still a lack of sufficient research examining its effects on spasticity, gross motor abilities, balance, and gait in children with CP.
There is one study comparing the effects of live and video forms of AOT on upper limb function in children with hemiparetic CP. The researchers found that live AOT was more effective than video AOT in improving upper limb performance.
To our knowledge, there are no previous studies that compare the effect of live and video forms of AOT on balance and gait in children with spastic diplegia. Addressing this gap may provide valuable insights into the optimal mode of AOT delivery for enhancing balance and gait.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A selected physical therapy program | Active comparator | Other: A selected physical therapy programFifteen children will receive one hour of a selected physical therapy program, three times per week for 3 months. |
| A selected physical therapy program + Live action observation training (AOT) | Experimental | Other: A selected physical therapy program, Other: Live action observation training (AOT)Fifteen children will receive 30 minutes of the same selected physical therapy program plus 30 minutes of live AOT, three times per week for 3 months. |
| A selected physical therapy program + Video action observation training (AOT) | Experimental | Other: A selected physical therapy program, Other: Video action observation training (AOT)Fifteen children will receive 30 minutes of the same selected physical therapy program plus 30 minutes of video AOT, three times per week for 3 months. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children of diplegia who walk by a crouch gait.
- The age of the selected children will range from 4 to 7 years old.
- Degree of spasticity will range from 1 to 1+, according to modified Ashworth scale (MAS).
- They will be selected as Level II according to Gross motor function classification system (GMFCS).
- They will be able to understand the tasks and researchers' instructions.
Key exclusion criteria (5 listed)
- Visual or auditory impairments.
- Vestibular impairments.
- Fixed deformities of the upper, lower limbs, and the spine.
- Botulinum toxin (Botox) injection for the last six months.
- Orthopedic surgeries in the last six 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 |
|---|---|---|
| A selected physical therapy programParticipants will receive a conventional physical therapy program, 3 sessions per week for 3 months. The program will include approximation exercises, balance training, functional activities (sit-to-stand, squatting, stair climbing), gait training with obstacles, walking exercises on different surfaces, and stretching exercises for the upper and lower limbs. The intervention aims to improve balance, mobility, coordination, and functional performance. | Other | A selected physical therapy program, A selected physical therapy program + Live action observation training (AOT), A selected physical therapy program + Video action observation training (AOT) |
| Live action observation training (AOT)Participants will receive live AOT for 30 minutes, 3 times per week, for 3 months. Each task will involve 3 minutes of observing the therapist performing the activity, followed by 3 minutes of verbal guidance and 3 minutes of task execution by the child. A 1-minute rest period will be provided between tasks. | Other | A selected physical therapy program + Live action observation training (AOT) |
| Video action observation training (AOT)Participants will receive video-based AOT for 30 minutes, 3 times per week, for 3 months. They will observe task demonstrations presented on a computer screen from multiple viewing angles, followed by guided practice and task performance, similar to the live AOT protocol. | Other | A selected physical therapy program + Video action observation training (AOT) |
Primary outcome
Overall Stability Index (OSI)
Time frame: 3 months
It will be assessed using the Biodex Balance System. Participants will stand on a dynamic platform at stability level 5 for three 30-second trials. The Overall Stability Index (OSI) will be recorded as a measure of postural stability in all directions. Lower OSI values indicate better balance control and greater postural stability.
Anteroposterior Stability Index (APSI)
Time frame: 3 months
It will be measured using the Biodex Balance System during dynamic balance testing. APSI reflects the participant's ability to maintain balance in the forward and backward directions. Lower APSI scores indicate improved anteroposterior postural control.
Mediolateral Stability Index (MLSI)
Time frame: 3 months
It will be assessed using the Biodex Balance System. MLSI evaluates the participant's ability to control balance in the side-to-side direction during dynamic standing. Lower MLSI values indicate better mediolateral stability and balance performance.
3 secondary outcomes
Hip Flexion Angle
Time frame: 3 months
Knee Flexion Angle
Time frame: 3 months
Ankle Dorsiflexion Angle
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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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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Effects of Transcranial Direct Current Stimulation Combined With Virtual Reality on Gait and Self-Esteem in Children With Spastic Cerebral Palsy
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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.
Mai Elsayed Abbass, PhD contact
Eman Ibrahem El-Hadidy, PhD study chair
Professor, Cairo university
Mai Elsayed Abbass, PhD study director
Ass. Professor, Cairo 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 A selected physical therapy program, Live action observation training (AOT) and Video action observation training (AOT) in people with Spastic Diplegia, 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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 16 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esraa Elsayed Ali Elkiky, M.Sc (+20 10 92002696, esraa.elkiky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Stability Index (OSI) (time frame: 3 months). The study lists 3 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 16 Jun 2026.