Cerebral PalsyNCT06568848
Effects of EKKO Versus Conservative Treatment for Gross Motor Functions in Cerebral Palsy Patients
A study testing EKKO therapy and Conservative Treatment in people with Cerebral Palsy, run by Superior University at 1 site in Pakistan.
Trial summary
"Cerebral palsy (CP) affects gross motor function variably, with the spastic type notably impacting movement, coordination, and balance. Research highlights that spastic CP, characterized by muscle stiffness, can severely hinder activities like walking and running. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- EKKO therapy and Conservative Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 30 Oct 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. cerebral palsy (CP)
- Severity: Typically applied to those with mild to moderate CP
Who cannot join
- Participants without a confirmed diagnosis of cerebral palsy or any other neurological condition
- Severe cp cases may be excluded
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Little angles home sailkot cantt aziz bhati shaheed road opposit junior aps
Sialkot, Punjab Province
About this study
"Cerebral palsy (CP) affects gross motor function variably, with the spastic type notably impacting movement, coordination, and balance. Research highlights that spastic CP, characterized by muscle stiffness, can severely hinder activities like walking and running. Interventions such as gait training and vibrational therapy have shown promise in enhancing muscle function and body movements. A new device, EKKO, uses vibrational waves based on Neurotransmission Cognitive Theory to improve gross motor skills in children with CP by applying mechanical vibrations to nerve points.
Read the detailed description
This study aims to compare the efficacy of EKKO therapy with traditional conservative treatments (such as range of motion exercises and balance training) in improving gross motor function in children with CP. Conducted over six months with randomized controlled trials, the research seeks to provide evidence-based insights into optimizing rehabilitation strategies for better motor performance and quality of life for CP patients.
- Conditions
- Cerebral Palsy
- Being tested
- EKKO therapy, Conservative Treatment
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EKKO therapyCombination product
In this group 6 particepents will be included .the interventions will be given for 10 seconds on each finger tips . the session will be 30 mins. 4 to 5 sessions per week
Conservative TreatmentDiagnostic test
In this group 6 participants will be included .: Conservative treatment, which includes ROM isometric exercises (20 repetitions per limb), stretching exercises (10 seconds per limb with 3 repetitions), balance training (standing without belts for 20 minutes), and gait training (walking with a frame). The session will be 30 mins
| Study group | Role | What they receive |
|---|---|---|
| Exp Group | Experimental | Not described Receives: Combination Product: EKKO therapy |
| Control Group | Active comparator | Not described Receives: Diagnostic Test: Conservative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMFM Scale
improvement in gross motor function, measured using the GMFM scale. The scale evaluates various dimensions such as sitting, rolling, jumping, crawling, kneeling, walking, and running. Assessments will be conducted at three points: pre-evaluation (month 1), mid-evaluation (month 3), and post-evaluation (end of month 6).
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start1 Nov 2023
- Primary completion1 May 2024
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Superior 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568848
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/739
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 23 Aug 2024
- 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 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of EKKO Versus Conservative Treatment for Gross Motor Functions in Cerebral Palsy Patients
- ClinicalTrials.gov ID
- NCT06568848
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/739
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 23 Aug 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.
"Cerebral palsy (CP) affects gross motor function variably, with the spastic type notably impacting movement, coordination, and balance. Research highlights that spastic CP, characterized by muscle stiffness, can severely hinder activities like walking and running. Interventions such as gait training and vibrational therapy have shown promise in enhancing muscle function and body movements. A new device, EKKO, uses vibrational waves based on Neurotransmission Cognitive Theory to improve gross motor skills in children with CP by applying mechanical vibrations to nerve points.
Detailed description
This study aims to compare the efficacy of EKKO therapy with traditional conservative treatments (such as range of motion exercises and balance training) in improving gross motor function in children with CP. Conducted over six months with randomized controlled trials, the research seeks to provide evidence-based insights into optimizing rehabilitation strategies for better motor performance and quality of life for CP patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exp Group | Experimental | Combination Product: EKKO therapy |
| Control Group | Active comparator | Diagnostic Test: Conservative Treatment |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 1. cerebral palsy (CP)
- Severity: Typically applied to those with mild to moderate CP
Key exclusion criteria (2 listed)
- Participants without a confirmed diagnosis of cerebral palsy or any other neurological condition
- Severe cp cases may be excluded
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 |
|---|---|---|
| EKKO therapyIn this group 6 particepents will be included .the interventions will be given for 10 seconds on each finger tips . the session will be 30 mins. 4 to 5 sessions per week | Combination product | Exp Group |
| Conservative TreatmentIn this group 6 participants will be included .: Conservative treatment, which includes ROM isometric exercises (20 repetitions per limb), stretching exercises (10 seconds per limb with 3 repetitions), balance training (standing without belts for 20 minutes), and gait training (walking with a frame). The session will be 30 mins | Diagnostic test | Control Group |
Primary outcome
GMFM Scale
Time frame: 12 Months
improvement in gross motor function, measured using the GMFM scale. The scale evaluates various dimensions such as sitting, rolling, jumping, crawling, kneeling, walking, and running. Assessments will be conducted at three points: pre-evaluation (month 1), mid-evaluation (month 3), and post-evaluation (end of month 6).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EKKO therapy and Conservative Treatment in people with Cerebral Palsy, run by Superior 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Aug 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 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?
Results are not available in the source record.
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?
GMFM Scale (time frame: 12 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 23 Aug 2024.