Cerebral PalsyNCT06407323
Pediatric Rehabilitation for Children With Cerebral Palsy Through PVT Using AI to Reduce Spasticity
A study testing Personalized vibration therapy powered by AI and Physical therapy treatment in people with Cerebral Palsy, run by Superior University at 2 sites in Pakistan.
Trial summary
The study foucs on pediatric rehabilitation for children with cerebral palsy through personalized vibration therapy powered by artificial intelligence. Read more about this study
- Who is it for?
- Ages 2 to 9 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Personalized vibration therapy powered by AI and Physical therapy treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Oct 2023to 1 Sep 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 2 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed spastic CP as per neurologist report, GMFCS level I-III
- Ability to safely withstand intensity of vibrating device.
- have no planned surgery within 5 months before/after entering the study
Who cannot join
- A bone fracture within 12 weeks of enrollment.
- History of using anabolic agents, glucocorticoids (excluding inhaled), or growth hormone (regardless of dose) for at least 1 month, within the 3 months prior to enrollment.
- History of botulinum toxin injection into the lower limb(s) within the 3 months before enrollment.
- History of an illness or findings on physical examination that might prevent the child from completing the study (e.g., acute thrombosis, tendinitis).
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Johar pain relief center
Lahore, Punjab Province, 54600
Ali Fatima hospital
Lahore, Punjab Province
About this study
Official title: Pediatric Rehabilitation for Children With Cerebral Palsy Through Personalized Vibration Therapy Powered By Artificial Intelligence: An Innovative Approach to Reduce Spasticity and Improved Motor Function and Quality Of Life
The study foucs on pediatric rehabilitation for children with cerebral palsy through personalized vibration therapy powered by artificial intelligence.
Read the detailed description
Innovative approach to reduce spasticity, improved motor function, quality of life. Vibration therapy reduces spasticity by activating the body's natural stretch reflex, which in turn triggers muscular contractions. Furthermore, it has been proposed that the primary ends of the muscle spindle Ia afferent are stimulated by muscular vibration. This leads to the excitation of alpha motor neurons, subsequent contractions of motor units, ultimately producing a tonic muscle contraction. This study will modify vibration therapy by introducing Artificial intelligence to rehabilitate the patients suffering from spastic CP.
- Conditions
- Cerebral Palsy
- Being tested
- Personalized vibration therapy powered by AI, Physical therapy 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.
Personalized vibration therapy powered by AIDiagnostic test
A target frequency of either 20 Hz or 25 Hz, and amplitude 2-4 mm The whole treatment session will be around 20 minutes along with hot pack as a baseline treatment, consisted of 6 sessions per week for total 8 weeks of duration
Physical therapy treatmentOther
A selected physical therapy treatment program for spastic diplegic CP.
| Study group | Role | What they receive |
|---|---|---|
| Personalized vibration therapy powered by AI | Experimental | Not described Receives: Diagnostic Test: Personalized vibration therapy powered by AI |
| physical therapy treatment | Other | Not described Receives: Other: Physical therapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale
It is used to assess spasticity of neurological disorder patients. For scores on the Modified Ashworth Scale, there was satisfactory inter- and intra-rater agreement. The results of the Modified Ashworth Scale showed more reliability in measuring the upper extremities than the lower. The inter-rater reliability of the ratings for the lower and upper extremities was statistically correlated with a number of study parameters
Measured: 12 Months
Quality of life-child Questionnaire
The first health condition-specific questionnaire created specifically to measure quality of life (QOL) in children with cerebral palsy (CP) is the Cerebral Palsy Quality of Life for Children (CP QOL-Child). For primary carers, intra-class correlation values varied from.88 to.97, while for children, they were between.91 and.98. The assessment of children with cerebral palsy (CP) using the Turkish version of the CP QOL questionnaire was found to be a valid and dependable method. b)Gross Motor Function Classification System There was 0.84 interrater reliability. The GMFCS level and motor development tests had a stronger correlation than the GMFCS level and non-motor development tests.
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 posted9 May 2024
- Study start1 Oct 2023
- Primary completion1 Feb 2024
- Study completion1 Sep 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
- 32 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
- NCT06407323
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/704
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 9 May 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 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Rehabilitation for Children With Cerebral Palsy Through Personalized Vibration Therapy Powered By Artificial Intelligence: An Innovative Approach to Reduce Spasticity and Improved Motor Function and Quality Of Life
- ClinicalTrials.gov ID
- NCT06407323
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/704
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 9 May 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 foucs on pediatric rehabilitation for children with cerebral palsy through personalized vibration therapy powered by artificial intelligence.
Detailed description
Innovative approach to reduce spasticity, improved motor function, quality of life. Vibration therapy reduces spasticity by activating the body's natural stretch reflex, which in turn triggers muscular contractions. Furthermore, it has been proposed that the primary ends of the muscle spindle Ia afferent are stimulated by muscular vibration. This leads to the excitation of alpha motor neurons, subsequent contractions of motor units, ultimately producing a tonic muscle contraction. This study will modify vibration therapy by introducing Artificial intelligence to rehabilitate the patients suffering from spastic CP.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized vibration therapy powered by AI | Experimental | Diagnostic Test: Personalized vibration therapy powered by AI |
| physical therapy treatment | Other | Other: Physical therapy treatment |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosed spastic CP as per neurologist report, GMFCS level I-III
- Ability to safely withstand intensity of vibrating device.
- have no planned surgery within 5 months before/after entering the study
Key exclusion criteria (4 listed)
- A bone fracture within 12 weeks of enrollment.
- History of using anabolic agents, glucocorticoids (excluding inhaled), or growth hormone (regardless of dose) for at least 1 month, within the 3 months prior to enrollment.
- History of botulinum toxin injection into the lower limb(s) within the 3 months before enrollment.
- History of an illness or findings on physical examination that might prevent the child from completing the study (e.g., acute thrombosis, tendinitis).
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 |
|---|---|---|
| Personalized vibration therapy powered by AIA target frequency of either 20 Hz or 25 Hz, and amplitude 2-4 mm The whole treatment session will be around 20 minutes along with hot pack as a baseline treatment, consisted of 6 sessions per week for total 8 weeks of duration | Diagnostic test | Personalized vibration therapy powered by AI |
| Physical therapy treatmentA selected physical therapy treatment program for spastic diplegic CP. | Other | physical therapy treatment |
Primary outcome
Modified Ashworth Scale
Time frame: 12 Months
It is used to assess spasticity of neurological disorder patients. For scores on the Modified Ashworth Scale, there was satisfactory inter- and intra-rater agreement. The results of the Modified Ashworth Scale showed more reliability in measuring the upper extremities than the lower. The inter-rater reliability of the ratings for the lower and upper extremities was statistically correlated with a number of study parameters
Quality of life-child Questionnaire
Time frame: 12 months
The first health condition-specific questionnaire created specifically to measure quality of life (QOL) in children with cerebral palsy (CP) is the Cerebral Palsy Quality of Life for Children (CP QOL-Child). For primary carers, intra-class correlation values varied from.88 to.97, while for children, they were between.91 and.98. The assessment of children with cerebral palsy (CP) using the Turkish version of the CP QOL questionnaire was found to be a valid and dependable method. b)Gross Motor Function Classification System There was 0.84 interrater reliability. The GMFCS level and motor development tests had a stronger correlation than the GMFCS level and non-motor development tests.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized vibration therapy powered by AI and Physical therapy treatment in people with Cerebral Palsy, run by Superior University at 2 sites 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 3 inclusion and 4 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 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Modified Ashworth Scale (time frame: 12 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 9 May 2024.