Diplegic Spastic Cerebral PalsyNCT06303336
Effects OF NMES With and Without Dynamic Bracing on Spasticity and Movement Quality in CP
A study testing NMES with Dynamic Bracing, NMES without Dynamic Bracing and Dynamic Bracing Only in people with Diplegic Spastic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study aims at comparing Neuromuscular electrical Stimulation with and without dynamic bracing on spasticity and movement quality of lower limb in Children with Cerebral Palsy Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Diplegic Spastic Cerebral Palsy
- What is being tested?
- NMES with Dynamic Bracing, NMES without Dynamic Bracing and Dynamic Bracing Only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Dec 2023to 14 May 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 5 to 12 years.
- Able to walk with or without an assistive device. Classification as level I-II on the Gross Motor Functional Classification System (GMFCS).
- Able to stand with or without support for 1 minute.
- Classification as levels I-III on the Manual Ability Classification System (MACS); and the ability to follow and accept verbal instructions.
- Muscle tone scored ≥2, according to Modified Ashworth Scale.
Who cannot join
- Orthopedic Surgical intervention (e.g. tendon lengthening in lower limb) within the previous 12 months
- Treatment with botulinum toxin in the calf muscles within the previous 6 months
- Presence of structural deformities at the lower limbs and trunk, or instability in the ankle joint, which could compromise the child's safety and performance of the motor task
- Severe affective or psychiatric impairments;
- Serious vision or hearing problems
- Any neurological impairment (epilepsy or any other disease that would interfere with physical activity)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Neuromuscular Electrical Stimulation With and Without Dynamic Bracing on Lower Extremity Spasticity and Quality of Movement in Children With Cerebral Palsy
The study aims at comparing Neuromuscular electrical Stimulation with and without dynamic bracing on spasticity and movement quality of lower limb in Children with Cerebral Palsy
Read the detailed description
Cerebral palsy (CP) is a lifelong motor impairment caused by an early brain injury and affects 2-3 per 1,000 live births. It is a complex medical condition that negatively impacts cognition, language, sensations, movement, and gait patterns. It is normally carried out using a comprehensive approach that incorporates numerous approaches targeted at minimizing symptoms and improving functional outcomes.
NMES (Neuromuscular and Muscular Electrical Stimulation) is an instrument that provides electrical impulses to nerves, causing muscles to contract, while dynamic bracing use muscle power to pre-compress soft tissue to produce the high forces required to control specific pathological diseases.
The hip adductors, the knee flexor muscles, and the ankle and foot muscles (gastrocnemius and soleus may experience increased tone, causing the ankles to be held in a plantar-flexed (pointed downward) position) are targeted with NMES in the lower extremity to reduce the spasticity \& improve the quality of movement in CP children. Investigating how combining NMES with dynamic bracing benefits lumbar disc bulge patients adds to the growing body of evidence supporting multimodal treatment.
- Conditions
- Diplegic Spastic Cerebral Palsy
- Being tested
- NMES with Dynamic Bracing, NMES without Dynamic Bracing, Dynamic Bracing Only
- Keywords
- NMES, Dynamic Bracing, Cerebral Palsy, lower extremity
- Medical subject headings
- Cerebral palsy, spastic, diplegic, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMES with Dynamic BracingOther
The group will receive NMES along with dynamic bracing
NMES without Dynamic BracingOther
The participants will receive NMES on the lower extremity
Dynamic Bracing OnlyOther
This group will receive dynamic bracing only on the lower limb.
| Study group | Role | What they receive |
|---|---|---|
| NMES with Dynamic Bracing | Experimental | The NMES targeting the hip adductors, the knee flexor muscles and the ankle \& foot muscles, along with dynamic bracing Receives: Other: NMES with Dynamic Bracing |
| NMES without Dynamic Bracing | Experimental | Neuromuscular Electrical Stimulator targeting the lower extremity Receives: Other: NMES without Dynamic Bracing |
| Dynamic Bracing Only | Experimental | Dynamic Bracing of lower extremity Receives: Other: Dynamic Bracing Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale
The scale is used to measure spasticity minimum score is 0 and maximum score is 4
Measured: baseline and 6 weeks
Observable Movement Quality Scale
it is used assess the movement quality in children Minimum Score: 0 (indicating the poorest movement quality) and maximum is 24
Measured: baseline and 6 weeks
Physicians Rating Scale
it is used to objectively documenting the hip, knee, ankle and foot changes in children with CP. Minimum Score: 0 (indicating no impairment or lowest severity) and Maximum score is 7
Measured: baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start30 Dec 2023
- Primary completion14 May 2024
- Study completion14 May 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 Riphah International 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayesha Ashraf, MS NMPT*, Principal investigator, Ripha International UniverisityAmmara Abbas, tDPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303336
- Sponsor's protocol ID
- REC/0258 Ayesha Ashraf
- Status last verified
- Apr 2025
- First submitted
- 4 Mar 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuromuscular Electrical Stimulation With and Without Dynamic Bracing on Lower Extremity Spasticity and Quality of Movement in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06303336
- Acronym / sponsor ID
- REC/0258 Ayesha Ashraf
- Conditions
- Diplegic Spastic Cerebral Palsy
- Keywords
- NMES, Dynamic Bracing, Cerebral Palsy, lower extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 12 Mar 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 aims at comparing Neuromuscular electrical Stimulation with and without dynamic bracing on spasticity and movement quality of lower limb in Children with Cerebral Palsy
Detailed description
Cerebral palsy (CP) is a lifelong motor impairment caused by an early brain injury and affects 2-3 per 1,000 live births. It is a complex medical condition that negatively impacts cognition, language, sensations, movement, and gait patterns. It is normally carried out using a comprehensive approach that incorporates numerous approaches targeted at minimizing symptoms and improving functional outcomes.
NMES (Neuromuscular and Muscular Electrical Stimulation) is an instrument that provides electrical impulses to nerves, causing muscles to contract, while dynamic bracing use muscle power to pre-compress soft tissue to produce the high forces required to control specific pathological diseases.
The hip adductors, the knee flexor muscles, and the ankle and foot muscles (gastrocnemius and soleus may experience increased tone, causing the ankles to be held in a plantar-flexed (pointed downward) position) are targeted with NMES in the lower extremity to reduce the spasticity \& improve the quality of movement in CP children. Investigating how combining NMES with dynamic bracing benefits lumbar disc bulge patients adds to the growing body of evidence supporting multimodal treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NMES with Dynamic Bracing | Experimental | Other: NMES with Dynamic BracingThe NMES targeting the hip adductors, the knee flexor muscles and the ankle \& foot muscles, along with dynamic bracing |
| NMES without Dynamic Bracing | Experimental | Other: NMES without Dynamic BracingNeuromuscular Electrical Stimulator targeting the lower extremity |
| Dynamic Bracing Only | Experimental | Other: Dynamic Bracing OnlyDynamic Bracing of lower extremity |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age between 5 to 12 years.
- Able to walk with or without an assistive device. Classification as level I-II on the Gross Motor Functional Classification System (GMFCS).
- Able to stand with or without support for 1 minute.
- Classification as levels I-III on the Manual Ability Classification System (MACS); and the ability to follow and accept verbal instructions.
- Muscle tone scored ≥2, according to Modified Ashworth Scale.
Key exclusion criteria (6 listed)
- Orthopedic Surgical intervention (e.g. tendon lengthening in lower limb) within the previous 12 months
- Treatment with botulinum toxin in the calf muscles within the previous 6 months
- Presence of structural deformities at the lower limbs and trunk, or instability in the ankle joint, which could compromise the child's safety and performance of the motor task
- Severe affective or psychiatric impairments;
- Serious vision or hearing problems
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 |
|---|---|---|
| NMES with Dynamic BracingThe group will receive NMES along with dynamic bracing | Other | NMES with Dynamic Bracing |
| NMES without Dynamic BracingThe participants will receive NMES on the lower extremity | Other | NMES without Dynamic Bracing |
| Dynamic Bracing OnlyThis group will receive dynamic bracing only on the lower limb. | Other | Dynamic Bracing Only |
Primary outcome
Modified Ashworth Scale
Time frame: baseline and 6 weeks
The scale is used to measure spasticity minimum score is 0 and maximum score is 4
Observable Movement Quality Scale
Time frame: baseline and 6 weeks
it is used assess the movement quality in children Minimum Score: 0 (indicating the poorest movement quality) and maximum is 24
Physicians Rating Scale
Time frame: baseline and 6 weeks
it is used to objectively documenting the hip, knee, ankle and foot changes in children with CP. Minimum Score: 0 (indicating no impairment or lowest severity) and Maximum score is 7
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 9 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Diplegic Spastic Cerebral Palsy
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Dual-Task Training in Children With Spastic Diplegic Cerebral Palsy
Spastic Diplegia 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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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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Effects of Transcranial Direct Current Stimulation Combined With Virtual Reality on Balance and Executive Functions in Children With Spastic Diplegic 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. This study is not recruiting at the moment.
Ayesha Ashraf, MS NMPT* principal investigator
Ripha International Univerisity
Ammara Abbas, tDPT principal investigator
Riphah International 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 NMES with Dynamic Bracing, NMES without Dynamic Bracing and Dynamic Bracing Only in people with Diplegic Spastic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
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 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: finished, as of the sponsor's last update on 9 Apr 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 Pakistan. 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?
Modified Ashworth Scale (time frame: baseline and 6 weeks). 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 9 Apr 2025.