Hemiplegic Cerebral PalsyNCT07069946
Weight Bearing Exercises With NMES on Balance and Functional Abilities In Children With Hemiplegia
A study testing traditional physical therapy and weight-bearing exercise and neuromuscular electrical stimulation , traditional physical therapy and weight-bearing exercise in people with Hemiplegic Cerebral Palsy, run by Cairo University.
Trial summary
This study will be conducted to investigate the combining effect of weight-bearing exercises program with neuromuscular electrical stimulation on balance and functional abilities in children with hemiplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- traditional physical therapy and weight-bearing exercise and neuromuscular electrical stimulation , traditional physical therapy and weight-bearing exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2025to 15 Dec 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with hemiplegic cerebral palsy.
- Their age will range from 6-10 years.
- Both sexes will be included.
- All participants will be able to follow simple commands.
- They will be graded as mild spasticity of the lower limbs according to MAS grade 1 to 1+ .
- They will be at levels I and II based on the GMFCS
Who cannot join
- Children with any neurological conditions other than hemiplegic cerebral palsy will be excluded from the study.
- Musculoskeletal problems or congenital deformity.
- Children with fixed contracture.
- Lower limb surgery in the last one year.
- Rhizotomy, or injection of botulinum toxin into the lower limb muscles during the previous 6 months.
- Receive any medications that affect the arousal and alertness status.
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- Children having epilepsy.
- Visual or auditory defects.
- Skin sensitivity.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Abdulrahman Mostafa contact
About this study
Official title: Effect of Weight Bearing Exercises With Neuromuscular Electrical Stimulation on Balance and Functional Abilities In Children With Hemiplegia
This study will be conducted to investigate the combining effect of weight-bearing exercises program with neuromuscular electrical stimulation on balance and functional abilities in children with hemiplegic cerebral palsy.
Read the detailed description
Hemiplegic cerebral palsy (HCP) is characterized by unilateral motor impairment, with the upper extremities typically exhibiting greater functional limitations compared to the lower limbs. This subtype constitutes approximately 20-30% of cerebral palsy cases and arises from unilateral injury to the developing brain, resulting in asymmetrical muscle tone abnormalities, joint deformities, and restricted range of motion. Individuals with HCP often display irregular, uncoordinated movements on the affected side, significantly impacting motor performance. Children with spastic hemiplegia experience decreased balance ability and abnormal gait because of decreased weight-bearing in the paretic leg. Diminished motor ability in the paretic leg causes weakening of the quadriceps, ankle plantar flexors, and ankle dorsiflexors.
The rehabilitation of balance and walking ability is crucial for children diagnosed with cerebral palsy. Weight-bearing exercises are defined as physical activities in which the feet and legs support the body's weight while moving against gravity. These exercises are essential for stimulating bone growth, improving bone density, and enhancing musculoskeletal health. Examples of weight-bearing exercises include walking, running, jumping, dancing, climbing stairs, playing sports such as soccer or basketball, and engaging in recreational activities like hiking or skating. Regular participation in weight-bearing exercises is particularly important for children and adolescents, as it helps maximize peak bone mass during growth and reduces the risk of osteoporosis later in life.
Exercise programs for cerebral palsy exhibit significant variation in terms of their types, such as gait training, body-weight-supported treadmill training, balance training, or multi-component approaches, and the efficacy of different exercises has not been established in improving the functional abilities of children with cerebral palsy. Studies suggest that integrating neuromuscular electrical stimulation (NMES) with conventional rehabilitation approaches enhances therapeutic outcomes compared to using NMES in isolation .
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- traditional physical therapy and weight-bearing exercise, neuromuscular electrical stimulation , traditional physical therapy and weight-bearing exercise
- Keywords
- weight-bearing exercises program, neuromuscular electrical stimulation, balance, functional abilities, hemiplegic cerebral palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional physical therapy and weight-bearing exerciseOther
They will receive 60 minute session, 3 times/ week for 8 weeks as following:
- 30 minutes of traditional physical therapy program : Includes: Strengthening, Stretching, Balance, Postural Control, Functional Mobility and Gait Training.
- 30 minutes of seven different weight-bearing exercises program of exercises with three of those being repeated on the left and right sides to make a total of ten exercises, each held for 3 minutes, the exercises include: hamstring stretch, calf stretch, half kneeling balance, static squat, bridge, four point kneeling and four point kneeling with leg extension the exercises include: : Hamstring stretch,Calf stretch , Half kneeling balance , Static Squat, Bridge, Four point kneeling with leg extension, and Four point kneeling.
neuromuscular electrical stimulation , traditional physical therapy and weight-bearing exerciseOther
They will receive 60 minute session, 3 times/ week for 8 weeks as following:
- 30 minutes of the same traditional physical therapy as the control group.
- 30 minutes of the same weight-bearing exercises program as the control group adding to it the neuromuscular electrical stimulation on: Tibialis anterior, Quadriceps, Paraspinal muscles.
- NMES Parameters :
- Device: Everyway-EV-906.
- Frequency: 30-35 Hz (to optimize muscle endurance and motor unit recruitment).
- Pulse Width: 250-300 µs.
- Intensity: Adjusted to elicit visible muscle contraction without discomfort (submaximal, (25-30 mA).
- Electrode Placement:
- Lower Limb: Tibialis anterior (for dorsiflexion) and quadriceps (for knee stability) during weight-bearing (El-Shamy and El Kafy, 2021).
- Trunk: Paraspinal muscles (for postural control) during static squats and bridging
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | This group will include 15 children with hemiplegic cerebral palsy and will receive a split 60 minutes, 30 minutes of traditional physical therapy and 30 minutes of weight-bearing exercise , 3 sessions/ week for 8 weeks. Receives: Other: traditional physical therapy and weight-bearing exercise |
| Study group | Experimental | This group will include 15 children with hemiplegic cerebral palsy and will receive the same 60 minutes session of the control group in addition to neuromuscular electrical stimulation during the 30 minutes weight-bearing program , 3 sessions/ week for 8 weeks. Receives: Other: neuromuscular electrical stimulation , traditional physical therapy and weight-bearing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
The HUMAC Balance System (HUMAC2015® Version: 15.000.0103; Computer Sports Medicine, Inc.) will assess pediatric postural balance before and after treatment. This system, featuring a force plate and specialized software, provides precise and reliable measurements of static and dynamic balance, supported by established reliability in pediatric studies.
Measured: up to 8 Weeks
Secondary outcomes (1)
The Gross Motor Function Measure GMFM
The GMFM Will be used for functional abilities evaluation for all children participating in the study before and after treatment procedures. Including the 88-item (GMFM-88) and 66-item (GMFM-66) versions, assesses gross motor function changes in children with cerebral palsy. Both demonstrate high validity and reliability . An adapted GMFM-88 version shows excellent test-retest and inter observer reliability
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic 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
- weight-bearing exercise and neuromuscular electrical stimulation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulrahman Ahmad Mohamad Mostafa, Cairo University
- Investigators
- Abdulrahman Mostafa, MSc., Principal investigator, Master degree
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069946
- Sponsor's protocol ID
- No:P.T.REC/012/005783
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 17 Jul 2025
- 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 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Weight Bearing Exercises With Neuromuscular Electrical Stimulation on Balance and Functional Abilities In Children With Hemiplegia
- ClinicalTrials.gov ID
- NCT07069946
- Acronym / sponsor ID
- No:P.T.REC/012/005783
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- weight-bearing exercises program, neuromuscular electrical stimulation, balance, functional abilities, hemiplegic cerebral palsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 17 Jul 2025 (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.
This study will be conducted to investigate the combining effect of weight-bearing exercises program with neuromuscular electrical stimulation on balance and functional abilities in children with hemiplegic cerebral palsy.
Detailed description
Hemiplegic cerebral palsy (HCP) is characterized by unilateral motor impairment, with the upper extremities typically exhibiting greater functional limitations compared to the lower limbs. This subtype constitutes approximately 20-30% of cerebral palsy cases and arises from unilateral injury to the developing brain, resulting in asymmetrical muscle tone abnormalities, joint deformities, and restricted range of motion. Individuals with HCP often display irregular, uncoordinated movements on the affected side, significantly impacting motor performance. Children with spastic hemiplegia experience decreased balance ability and abnormal gait because of decreased weight-bearing in the paretic leg. Diminished motor ability in the paretic leg causes weakening of the quadriceps, ankle plantar flexors, and ankle dorsiflexors.
The rehabilitation of balance and walking ability is crucial for children diagnosed with cerebral palsy. Weight-bearing exercises are defined as physical activities in which the feet and legs support the body's weight while moving against gravity. These exercises are essential for stimulating bone growth, improving bone density, and enhancing musculoskeletal health. Examples of weight-bearing exercises include walking, running, jumping, dancing, climbing stairs, playing sports such as soccer or basketball, and engaging in recreational activities like hiking or skating. Regular participation in weight-bearing exercises is particularly important for children and adolescents, as it helps maximize peak bone mass during growth and reduces the risk of osteoporosis later in life.
Exercise programs for cerebral palsy exhibit significant variation in terms of their types, such as gait training, body-weight-supported treadmill training, balance training, or multi-component approaches, and the efficacy of different exercises has not been established in improving the functional abilities of children with cerebral palsy. Studies suggest that integrating neuromuscular electrical stimulation (NMES) with conventional rehabilitation approaches enhances therapeutic outcomes compared to using NMES in isolation .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- weight-bearing exercise and neuromuscular electrical stimulation
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: traditional physical therapy and weight-bearing exerciseThis group will include 15 children with hemiplegic cerebral palsy and will receive a split 60 minutes, 30 minutes of traditional physical therapy and 30 minutes of weight-bearing exercise , 3 sessions/ week for 8 weeks. |
| Study group | Experimental | Other: neuromuscular electrical stimulation , traditional physical therapy and weight-bearing exerciseThis group will include 15 children with hemiplegic cerebral palsy and will receive the same 60 minutes session of the control group in addition to neuromuscular electrical stimulation during the 30 minutes weight-bearing program , 3 sessions/ week for 8 weeks. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children diagnosed with hemiplegic cerebral palsy.
- Their age will range from 6-10 years.
- Both sexes will be included.
- All participants will be able to follow simple commands.
- They will be graded as mild spasticity of the lower limbs according to MAS grade 1 to 1+ .
Key exclusion criteria (9 listed)
- Children with any neurological conditions other than hemiplegic cerebral palsy will be excluded from the study.
- Musculoskeletal problems or congenital deformity.
- Children with fixed contracture.
- Lower limb surgery in the last one year.
- Rhizotomy, or injection of botulinum toxin into the lower limb muscles during the previous 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 |
|---|---|---|
| traditional physical therapy and weight-bearing exerciseThey will receive 60 minute session, 3 times/ week for 8 weeks as following: * 30 minutes of traditional physical therapy program : Includes: Strengthening, Stretching, Balance, Postural Control, Functional Mobility and Gait Training. * 30 minutes of seven different weight-bearing exercises program of exercises with three of those being repeated on the left and right sides to make a total of ten exercises, each held for 3 minutes, the exercises include: hamstring stretch, calf stretch, half kneeling balance, static squat, bridge, four point kneeling and four point kneeling with leg extension the exercises include: : Hamstring stretch,Calf stretch , Half kneeling balance , Static Squat, Bridge, Four point kneeling with leg extension, and Four point kneeling. | Other | Control group |
| neuromuscular electrical stimulation , traditional physical therapy and weight-bearing exerciseThey will receive 60 minute session, 3 times/ week for 8 weeks as following: * 30 minutes of the same traditional physical therapy as the control group. * 30 minutes of the same weight-bearing exercises program as the control group adding to it the neuromuscular electrical stimulation on: Tibialis anterior, Quadriceps, Paraspinal muscles. * NMES Parameters : * Device: Everyway-EV-906. * Frequency: 30-35 Hz (to optimize muscle endurance and motor unit recruitment). * Pulse Width: 250-300 µs. * Intensity: Adjusted to elicit visible muscle contraction without discomfort (submaximal, (25-30 mA). * Electrode Placement: * Lower Limb: Tibialis anterior (for dorsiflexion) and quadriceps (for knee stability) during weight-bearing (El-Shamy and El Kafy, 2021). * Trunk: Paraspinal muscles (for postural control) during static squats and bridging | Other | Study group |
Primary outcome
Balance
Time frame: up to 8 Weeks
The HUMAC Balance System (HUMAC2015® Version: 15.000.0103; Computer Sports Medicine, Inc.) will assess pediatric postural balance before and after treatment. This system, featuring a force plate and specialized software, provides precise and reliable measurements of static and dynamic balance, supported by established reliability in pediatric studies.
1 secondary outcome
The Gross Motor Function Measure GMFM
Time frame: Up to 8 weeks
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 17 Jul 2025.
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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.
Abdulrahman Mostafa contact
Abdulrahman Mostafa, MSc. principal investigator
Master degree
Questions about this trial
What is this clinical trial studying?
A study testing traditional physical therapy and weight-bearing exercise and neuromuscular electrical stimulation , traditional physical therapy and weight-bearing exercise in people with Hemiplegic Cerebral Palsy, run by Cairo University.
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 9 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 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Abdulrahman Mostafa, Master (0 11 01012521, ar.ahmad93pt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: up to 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 17 Jul 2025.