Cerebral PalsyNCT04894812
Vestibular and Motor Functions in Children With Hemiplegic Cerebral Palsy
A study testing Neurodevelopmental technique in people with Cerebral Palsy and Hemiplegic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
As many researches have been conducted to see the effects of vestibular system activation on gross motor activities of children with cerebral palsy but there are limited researches on improvement of motor abilities of hemiplegic cerebral palsy child using UEU or BOSU ball or treadmill in a single study. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Cerebral Palsy, Hemiplegic Cerebral Palsy
- What is being tested?
- Neurodevelopmental technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 31 Jan 2022
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 3 years to 12 years
- Gender: Both Male and female
- Children with Spastic Hemiplegic CP scoring 1,1+ and 2 on Modified Ashworth scale
- Level III and IV on GMFCS (Gross Motor Function Classification System)
Who cannot join
- Children with other types of Cerebral Palsy (diplegia, quadriplegia etc)
- Children with other Abnormalities and pathologies (delayed milestones, hydrocephalous, epilepsy etc)
- Children Undergone any kind of surgery (cardiac, shunt placement, orthopedic etc)
- Children with any other neurological deficits (spina bifida etc)
- Children with conditions in which vestibular stimulation is not allowed (paroxysmal positional vertigo or vestibular neuritis, Meniere's disease, migraine-associated vertigo, and childhood vertigo).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Institute of Pediatric Habilitation and Rehabilitation IPH
Lahore, Punjab Province
About this study
Official title: The Effect of Vestibular Stimulation Along With Neurodevelopmental Technique on Motor Functions of Children With Hemiplegic Cerebral Palsy
As many researches have been conducted to see the effects of vestibular system activation on gross motor activities of children with cerebral palsy but there are limited researches on improvement of motor abilities of hemiplegic cerebral palsy child using UEU or BOSU ball or treadmill in a single study. There is lack of research on vestibular stimulation in hemiplegic cerebral palsy along with neurodevelopmental treatment.
This study will improve the gross motor activities of children with hemiplegic cerebral palsy. It will broaden up the ways for physical therapist to deal with this type of cerebral palsy (hemiplegic).
Read the detailed description
There are various therapeutic approaches that are used to improve motor activities and postural control in CP child. Among these approaches vestibular stimulation is used to improve neuromotor development by different sensory stimulation techniques. It has shown positive effects on motor control of CP child. It also influences all sensory experiences and is an exercise based approach.
- Conditions
- Cerebral Palsy, Hemiplegic Cerebral Palsy
- Being tested
- Neurodevelopmental technique
- Keywords
- motor activity, spasticity, vestibular stimulation
- Medical subject headings
- Cerebral Palsy, Motor Activity, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodevelopmental techniqueOther
- st month: postural maintenance; exercises with weight on forearms and hands, in sitting, crawling, semi-kneeling and standing positions with support from therapist.
- nd month: balance and corrective reactions; using CP ball and tilt board.
- rd month: ambulation training; appropriate to motor development level (crawling, creeping, walking in a semi-kneeling position and walking between parallel bars).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Neurodevelopmental Treatment. Total duration of treatment will be 20 minutes, 3 sessions per for 3 months Receives: Other: Neurodevelopmental technique |
| Group B | Experimental | Neurodevelopmental Technique and Vestibular stimulation. Total duration of treatment will be 50 minutes (20 min NDT+ 30 MIN VS) 3 sessions per week for 3 months. Receives: Other: Neurodevelopmental technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMFM-88
It is a Standardized Observational Instrument designed and validated to measure change in gross motor function over time in children with Cerebral Palsy. The GMFM-88 item scores can be summed to calculate raw and percent scores for each of the five GMFM dimensions of interest, selected goal areas and a total GMFM-88 score.
Measured: 12 weeks
Secondary outcomes (1)
Modified Ashworth Scale
The purpose of the Modified Ashworth Scale is to measure spasticity in patients who have lesions of the CNS or neurological disorders. The MAS is a quick and easy measure that can assist a clinician's assessment of spasticity during passive soft-tissue stretching.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start30 May 2021
- Primary completion31 Dec 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirza Obaid Baig, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894812
- Sponsor's protocol ID
- REC/00757 Anam Tariq
- Status last verified
- Feb 2022
- First submitted
- 19 May 2021
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tramontano M, Medici A, Iosa M, Chiariotti A, Fusillo G, Manzari L, Morelli D. The Effect of Vestibular Stimulation on Motor Functions of Children With Cerebral Palsy. Motor Control. 2017 Jul;21(3):299-311. doi: 10.1123/mc.2015-0089. Epub 2016 Aug 19.
PubMed 27633076Bangash AS, Hanafi MZ, Idrees R, Zehra N. Risk factors and types of cerebral palsy. J Pak Med Assoc. 2014 Jan;64(1):103-7.
PubMed 24605730Labaf S, Shamsoddini A, Hollisaz MT, Sobhani V, Shakibaee A. Effects of Neurodevelopmental Therapy on Gross Motor Function in Children with Cerebral Palsy. Iran J Child Neurol. 2015 Spring;9(2):36-41.
PubMed 26221161
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vestibular Stimulation Along With Neurodevelopmental Technique on Motor Functions of Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04894812
- Acronym / sponsor ID
- REC/00757 Anam Tariq
- Conditions
- Cerebral Palsy, Hemiplegic Cerebral Palsy
- Keywords
- motor activity, spasticity, vestibular stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 20 May 2021 (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.
As many researches have been conducted to see the effects of vestibular system activation on gross motor activities of children with cerebral palsy but there are limited researches on improvement of motor abilities of hemiplegic cerebral palsy child using UEU or BOSU ball or treadmill in a single study. There is lack of research on vestibular stimulation in hemiplegic cerebral palsy along with neurodevelopmental treatment.
This study will improve the gross motor activities of children with hemiplegic cerebral palsy. It will broaden up the ways for physical therapist to deal with this type of cerebral palsy (hemiplegic).
Detailed description
There are various therapeutic approaches that are used to improve motor activities and postural control in CP child. Among these approaches vestibular stimulation is used to improve neuromotor development by different sensory stimulation techniques. It has shown positive effects on motor control of CP child. It also influences all sensory experiences and is an exercise based approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Neurodevelopmental techniqueNeurodevelopmental Treatment. Total duration of treatment will be 20 minutes, 3 sessions per for 3 months |
| Group B | Experimental | Other: Neurodevelopmental techniqueNeurodevelopmental Technique and Vestibular stimulation. Total duration of treatment will be 50 minutes (20 min NDT+ 30 MIN VS) 3 sessions per week for 3 months. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age: 3 years to 12 years
- Gender: Both Male and female
- Children with Spastic Hemiplegic CP scoring 1,1+ and 2 on Modified Ashworth scale
- Level III and IV on GMFCS (Gross Motor Function Classification System)
Key exclusion criteria (5 listed)
- Children with other types of Cerebral Palsy (diplegia, quadriplegia etc)
- Children with other Abnormalities and pathologies (delayed milestones, hydrocephalous, epilepsy etc)
- Children Undergone any kind of surgery (cardiac, shunt placement, orthopedic etc)
- Children with any other neurological deficits (spina bifida etc)
- Children with conditions in which vestibular stimulation is not allowed (paroxysmal positional vertigo or vestibular neuritis, Meniere's disease, migraine-associated vertigo, and childhood vertigo).
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 |
|---|---|---|
| Neurodevelopmental technique1. st month: postural maintenance; exercises with weight on forearms and hands, in sitting, crawling, semi-kneeling and standing positions with support from therapist. 2. nd month: balance and corrective reactions; using CP ball and tilt board. 3. rd month: ambulation training; appropriate to motor development level (crawling, creeping, walking in a semi-kneeling position and walking between parallel bars). | Other | Group A, Group B |
Primary outcome
GMFM-88
Time frame: 12 weeks
It is a Standardized Observational Instrument designed and validated to measure change in gross motor function over time in children with Cerebral Palsy. The GMFM-88 item scores can be summed to calculate raw and percent scores for each of the five GMFM dimensions of interest, selected goal areas and a total GMFM-88 score.
1 secondary outcome
Modified Ashworth Scale
Time frame: 12 weeks
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 22 Feb 2022.
- Background: PubMed 27633076Tramontano M, Medici A, Iosa M, Chiariotti A, Fusillo G, Manzari L, Morelli D. The Effect of Vestibular Stimulation on Motor Functions of Children With Cerebral Palsy. Motor Control. 2017 Jul;21(3):299-311. doi: 10.1123/mc.2015-0089. Epub 2016 Aug 19.
- Background: PubMed 24605730Bangash AS, Hanafi MZ, Idrees R, Zehra N. Risk factors and types of cerebral palsy. J Pak Med Assoc. 2014 Jan;64(1):103-7.
- Background: PubMed 26221161Labaf S, Shamsoddini A, Hollisaz MT, Sobhani V, Shakibaee A. Effects of Neurodevelopmental Therapy on Gross Motor Function in Children with Cerebral Palsy. Iran J Child Neurol. 2015 Spring;9(2):36-41.
- 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.
Mirza Obaid Baig, MSPT 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 Neurodevelopmental technique in people with Cerebral Palsy and Hemiplegic 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 4 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 22 Feb 2022. 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?
GMFM-88 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04894812, which also lists 3 linked publications.
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 22 Feb 2022.