Spastic DiplegiaNCT06676332
Effect of Multisensory Motor Imagery Training on Muscle Performance and Coordination in Children With Spastic Diplegia
A study testing motor imagery training and traditional physical therapy in people with Spastic Diplegia and Motor Imagery, run by Cairo University at 1 site in Egypt.
Trial summary
PURPOSE: The current study aims to: Determine the effect of multisensory motor imagery training on muscle performance including (peak torque, work, power) of trunk and knee flexors and extensors in children with spastic diplegia. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Spastic Diplegia, Motor Imagery
- What is being tested?
- motor imagery training and traditional physical therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Nov 2024to May 2025
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Their age will be ranged from 8-12 years.
- Mild degree of spasticity ranged from 1 to 1+ according to Modified Ashworth Scale
- Their motor function will be at level I and II according to Gross Motor Function Classification System GMFCS
- They will be able to follow instructions during evaluation and treatment.
Who cannot join
- - Cardiovascular or respiratory disorders.
- Botulinium muscular injection in the last 6 months
- Surgical interference in lower limbs and/or spine.
- Muscloskeletal problems or fixed deformities in the spine and/or lower extremities.
- Seizures.
- Visual or hearing impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
PURPOSE:
The current study aims to:
Read more
- Determine the effect of multisensory motor imagery training on muscle performance including (peak torque, work, power) of trunk and knee flexors and extensors in children with spastic diplegia.
- Determine the effect of multisensory motor imagery training on coordination, strength and agility in children with spastic diplegia.
BACKGROUND: Multisensory motor imagery training has an effect on muscle performance and coordination in children with spastic diplegia
HYPOTHESES: There will be no effect of multisensory motor imagery training on muscle performance, coordination and strength and agility in children with spastic diplegic CP.
RESEARCH QUESTION: Is there an effect of multisensory motor imagery training on coordination, strength and agility in children with spastic diplegia?
- Conditions
- Spastic Diplegia, Motor Imagery
- Being tested
- motor imagery training, traditional physical therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motor imagery trainingOther
Also called mental rehearsal exercises
Children in the study group will receive multisensory motor imagery training program 45 minutes. The training protocol consists of several parts that will be run through every training session according to Kumar et al. (2016):
- Watching videos of selected multisensory motor skills for 10 minutes.
- Mental rehearsal of these motor skills 10 minutes.
- Overt practice of the multisensory motor skills for 25 minutes. On the videos, the performance of the skill by a child aged 8-12 years will be shown. All the exercises will be looped to repeat for six to seven times. While projecting the video on the laptop screen, it will be ensured that the children are in a comfortable seating position and the screen is in their visual field. Repetition of the exercises was based on their ability which could be a minimum of five repetitions per session to a maximum of ten repetitions per exercise session.
traditional physical therapyOther
traditional physical therapy training program
| Study group | Role | What they receive |
|---|---|---|
| control | Sham comparator | traditional physical therapy program Receives: Other: traditional physical therapy |
| motor imagery | Experimental | multisensory motor imagery training plus the traditional physical therapy program Receives: Other: motor imagery training; Other: traditional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle performance
muscle performance of knee and trunk muscles will be assessed by Isokinetic dynamometer
Measured: through study completion average 3 months
coordination
coordination ill be assessed using BOT-2
Measured: through study completion average 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start16 Nov 2024
- Primary completionFeb 2025 (estimated)
- Study completionMay 2025 (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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayada Ibraheem Elmahdy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676332
- Sponsor's protocol ID
- 005278
- Status last verified
- Feb 2025
- First submitted
- 9 Sep 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- 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 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multisensory Motor Imagery Training on Muscle Performance and Coordination in Children With Spastic Diplegia
- ClinicalTrials.gov ID
- NCT06676332
- Acronym / sponsor ID
- 005278
- Conditions
- Spastic Diplegia, Motor Imagery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Nov 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 6 Nov 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.
PURPOSE:
The current study aims to:
- Determine the effect of multisensory motor imagery training on muscle performance including (peak torque, work, power) of trunk and knee flexors and extensors in children with spastic diplegia.
- Determine the effect of multisensory motor imagery training on coordination, strength and agility in children with spastic diplegia.
BACKGROUND: Multisensory motor imagery training has an effect on muscle performance and coordination in children with spastic diplegia
HYPOTHESES: There will be no effect of multisensory motor imagery training on muscle performance, coordination and strength and agility in children with spastic diplegic CP.
RESEARCH QUESTION: Is there an effect of multisensory motor imagery training on coordination, strength and agility in children with spastic diplegia?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Sham comparator | Other: traditional physical therapytraditional physical therapy program |
| motor imagery | Experimental | Other: motor imagery training, Other: traditional physical therapymultisensory motor imagery training plus the traditional physical therapy program |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Their age will be ranged from 8-12 years.
- Mild degree of spasticity ranged from 1 to 1+ according to Modified Ashworth Scale
- Their motor function will be at level I and II according to Gross Motor Function Classification System GMFCS
- They will be able to follow instructions during evaluation and treatment.
Key exclusion criteria (6 listed)
- - Cardiovascular or respiratory disorders.
- Botulinium muscular injection in the last 6 months
- Surgical interference in lower limbs and/or spine.
- Muscloskeletal problems or fixed deformities in the spine and/or lower extremities.
- Seizures.
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 |
|---|---|---|
| motor imagery trainingAlso: mental rehearsal exercisesChildren in the study group will receive multisensory motor imagery training program 45 minutes. The training protocol consists of several parts that will be run through every training session according to Kumar et al. (2016): * Watching videos of selected multisensory motor skills for 10 minutes. * Mental rehearsal of these motor skills 10 minutes. * Overt practice of the multisensory motor skills for 25 minutes. On the videos, the performance of the skill by a child aged 8-12 years will be shown. All the exercises will be looped to repeat for six to seven times. While projecting the video on the laptop screen, it will be ensured that the children are in a comfortable seating position and the screen is in their visual field. Repetition of the exercises was based on their ability which could be a minimum of five repetitions per session to a maximum of ten repetitions per exercise session. | Other | motor imagery |
| traditional physical therapytraditional physical therapy training program | Other | control, motor imagery |
Primary outcome
muscle performance
Time frame: through study completion average 3 months
muscle performance of knee and trunk muscles will be assessed by Isokinetic dynamometer
coordination
Time frame: through study completion average 3 months
coordination ill be assessed using BOT-2
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 18 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motor imagery training and traditional physical therapy in people with Spastic Diplegia and Motor Imagery, 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 18 Feb 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 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. Some participants in this study may receive a placebo. 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 Mayada Elshahawy (0201095022909, myadashahawy11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle performance (time frame: through study completion average 3 months). 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 18 Feb 2025.