Cerebral Palsy Spastic DiplegiaNCT06234215
Effect of Electrical Stimulation With Functional Task Training on Balance and Motor Abilities in Children With Diplegia
A study testing functional electrical stimulation and functional task training in people with Cerebral Palsy Spastic Diplegia, run by Cairo University at 1 site in Egypt.
Trial summary
The aims of the study are to: 1. Investigate the combined effect of functional task training with electrical stimulation of bilateral hip abductor muscles on balance in children with diplegia. 2. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Cerebral Palsy Spastic Diplegia
- What is being tested?
- functional electrical stimulation and functional task training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Jan 2023to 25 Nov 2023
- 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Their ages will range from 7-11 years.
- Both genders will be included.
- Their degree of spasticity will range from 1 to 1+ according to Modified Ashworth Scale (Meseguer-Henarejos et al., 2018).
- Their motor function will be at level I \& II according to Gross Motor Function --- -Classification system (Palisano et al., 2008).
- They will be understanding instructions.
Who cannot join
- Children will be excluded from the study if they have any of the following criteria:
- Musculoskeletal fixed deformities in upper limb, lower limb or spine.
- Visual or hearing problems.
- Epilepsy.
- Botulinium toxin therapy or orthopedic surgery within the past 6months or within the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Task Training Combined With Electrical Stimulation on Balance and Motor Abilities in Children With Diplegia
The aims of the study are to:
- Investigate the combined effect of functional task training with electrical stimulation of bilateral hip abductor muscles on balance in children with diplegia.
- Investigate the combined effect of functional task training with electrical stimulation of bilateral hip abductor muscles on motor abilities in children with diplegia.
Read the detailed description
Cerebral palsy (CP) is a group of permanent disorders of movement and posture. It is non-progressive lesion or abnormality of immature brain. The term cerebral refers to the brain and palsy refers to the loss or impairment of motor function.
Functional electrical stimulation (FES) is a subtype of neuromuscular electrical stimulation (NMES) in which the stimulation assists functional and purposeful movements. This is achieved by applying electrical stimulation to muscles that, when they contract, produce a movement that can be used functionally.The FES is used to provide electrical stimulation via the peripheral nervous system to activate muscle contractions to assist functional activities when nervous or musculo-skeletal systems are damaged.The common applications of FES include strengthening muscle, reducing muscle spasticity, increasing range of motion, improving upper extremity function and walking speed.
- Conditions
- Cerebral Palsy Spastic Diplegia
- Being tested
- functional electrical stimulation, functional task training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional electrical stimulationDevice
electrical stimulation during function
functional task trainingOther
functional exercise
| Study group | Role | What they receive |
|---|---|---|
| control group had functional task training | Active comparator | this group doing functional task training exercise for 50 min 3 times per week for two months Receives: Other: functional task training |
| study group had functional task training combined with electrical stimulation | Experimental | this group doing functional task training exercise combined with electrical stimulation for 50 min 3 times per week for two months Receives: Device: functional electrical stimulation; Other: functional task training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Humac balance system
static and dynamic balance when values inscrease the results are better.
Measured: two months
Secondary outcomes (1)
Growth motor functional scale
measuring motor abilities standing and walking when values increase the results are better.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start17 Jan 2023
- Primary completion12 Sep 2023
- Study completion25 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy 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
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa Adel, Cairo University
- Investigators
- Randa Adel, master, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234215
- Sponsor's protocol ID
- E.S and balance in diplegia
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2024
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Task Training Combined With Electrical Stimulation on Balance and Motor Abilities in Children With Diplegia
- ClinicalTrials.gov ID
- NCT06234215
- Acronym / sponsor ID
- E.S and balance in diplegia
- Conditions
- Cerebral Palsy Spastic Diplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 25 Nov 2023 (actual)
- First posted
- 31 Jan 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 aims of the study are to:
- Investigate the combined effect of functional task training with electrical stimulation of bilateral hip abductor muscles on balance in children with diplegia.
- Investigate the combined effect of functional task training with electrical stimulation of bilateral hip abductor muscles on motor abilities in children with diplegia.
Detailed description
Cerebral palsy (CP) is a group of permanent disorders of movement and posture. It is non-progressive lesion or abnormality of immature brain. The term cerebral refers to the brain and palsy refers to the loss or impairment of motor function.
Functional electrical stimulation (FES) is a subtype of neuromuscular electrical stimulation (NMES) in which the stimulation assists functional and purposeful movements. This is achieved by applying electrical stimulation to muscles that, when they contract, produce a movement that can be used functionally.The FES is used to provide electrical stimulation via the peripheral nervous system to activate muscle contractions to assist functional activities when nervous or musculo-skeletal systems are damaged.The common applications of FES include strengthening muscle, reducing muscle spasticity, increasing range of motion, improving upper extremity function and walking speed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group had functional task training | Active comparator | Other: functional task trainingthis group doing functional task training exercise for 50 min 3 times per week for two months |
| study group had functional task training combined with electrical stimulation | Experimental | Device: functional electrical stimulation, Other: functional task trainingthis group doing functional task training exercise combined with electrical stimulation for 50 min 3 times per week for two months |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Their ages will range from 7-11 years.
- Both genders will be included.
- Their degree of spasticity will range from 1 to 1+ according to Modified Ashworth Scale (Meseguer-Henarejos et al., 2018).
- Their motor function will be at level I \& II according to Gross Motor Function --- -Classification system (Palisano et al., 2008).
- They will be understanding instructions.
Key exclusion criteria (5 listed)
- Children will be excluded from the study if they have any of the following criteria:
- Musculoskeletal fixed deformities in upper limb, lower limb or spine.
- Visual or hearing problems.
- Epilepsy.
- Botulinium toxin therapy or orthopedic surgery within the past 6months or within the study period.
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 |
|---|---|---|
| functional electrical stimulationelectrical stimulation during function | Device | study group had functional task training combined with electrical stimulation |
| functional task trainingfunctional exercise | Other | control group had functional task training, study group had functional task training combined with electrical stimulation |
Primary outcome
Humac balance system
Time frame: two months
static and dynamic balance when values inscrease the results are better.
1 secondary outcome
Growth motor functional scale
Time frame: two months
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 31 Jan 2024.
Related trials for Cerebral Palsy Spastic Diplegia
Not yet recruiting
Dual-Task Training in Children With Spastic Diplegic Cerebral Palsy
Spastic Diplegia Cerebral Palsy
Active, not recruiting
Effect of Reactive Functional Motor Challenge Training on Dynamic Balance and Functional Mobility in Children With Spastic Diplegic Cerebral Palsy: A Randomized Comparative Trial.
Cerebral Palsy (CP), Spastic Diplegia Cerebral Palsy
Active, not recruiting
Oculomotor Training in Spastic Diplegia: Effects on Postural Stability and Motor Proficiency
Cerebral Palsy Spastic Diplegia
Recruiting
Effects of Proprioceptive Neuromuscular Facilitation and Task-Oriented Training on Upper Extremity Function in Children With Spastic Diplegic Cerebral Palsy
Cerebral Palsy, Spastic Diplegia
Not yet recruiting
Action Observation Therapy in Children With Spastic Diplegia
Spastic Diplegia
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.
Randa Adel, master principal investigator
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 functional electrical stimulation and functional task training in people with Cerebral Palsy 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 5 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: finished, as of the sponsor's last update on 31 Jan 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?
Humac balance system (time frame: two months). 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 31 Jan 2024; AzTrials last refreshed its copy on 30 Oct 2026.