Hypotonic Cerebral PalsyNCT05162092
Effects of Vestibular Stimulation on Motor Function and Balance in Children With Hypotonic Cerebral Palsy
A study testing Conventional physiotherapy and Vestibular stimulation with conventional physiotherapy in people with Hypotonic Cerebral Palsy, run by University of Lahore at 1 site in Pakistan.
Trial summary
my study base on 2groups with total sample size 68 patients .group A conventional physiotherapy group in which the duration of session is 30 mints with 5 mints rest .include soft tissue elogation of tight muscles,lowerlimb resistance exercise,movement transitions balance board standing walking and stair climbing.for… Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Hypotonic Cerebral Palsy
- What is being tested?
- Conventional physiotherapy and Vestibular stimulation with conventional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Jul 2021to 4 Mar 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age range from 5-10 years.
- both male/female
- have good head control
- hypotonic cerebral palsy
- able to maintained ring sitting position
Who cannot join
- children will not respond to visual and auditory stimuli due to blindness or deafness or sever mental retardation
- children with un controlled convulsion or vp shunt
- children with severe medical problems children with orthopedic condition
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Mahwash Zulfiqar
Lahore, Punjab Province
Mahwish Zulfiqar, MS MSK PT, 03355077906
About this study
my study base on 2groups with total sample size 68 patients .group A conventional physiotherapy group in which the duration of session is 30 mints with 5 mints rest .include soft tissue elogation of tight muscles,lowerlimb resistance exercise,movement transitions balance board standing walking and stair climbing.for group b (conventional physiotherapy and vestibular stimulation exercises)30 mints with 10 mints rest.same physiotherpy exercise re given with vestibular stimulation exercises include swinging in standing in all diection,trampoline jump,rocking movement in rocking chair gaze stabilization exercises and visual pursuit exercises
Read the detailed description
my study base on 2groups with total sample size 68 patients .group A conventional physiotherapy group in which the duration of session is 30 mints with 5 mints rest .include soft tissue elogation of tight muscles,lowerlimb resistance exercise,movement transitions balance board standing walking and stair climbing.for group b (conventional physiotherapy and vestibular stimulation exercises)30 mints with 10 mints rest.same physiotherpy exercise re given with vestibular stimulation exercises include swinging in standing in all diection,trampoline jump,rocking movement in rocking chair gaze stabilization exercises and visual pursuit exercises under supervisio. and use 2 scales,pediatric balance scale and gross motor scale re used for taking data .
- Conditions
- Hypotonic Cerebral Palsy
- Being tested
- Conventional physiotherapy, Vestibular stimulation with conventional physiotherapy
- Keywords
- vestibular stimulation, motor function, balance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physiotherapyOther
Participants will be given Conventional Physiotherapy. It included Passive Soft tissue elongation of tight muscles, Lower limb resistance exercises, Movement transitions, balance board and foam board standing, walking and stair climbing.
Vestibular stimulation with conventional physiotherapyOther
Participants in group B will be given conventional physiotherapy and vestibular stimulation exercises. It included conventional is same as given to the conventional and Vestibular Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | training duration for each session is 30 mints with 5 mints rest and it includes passive soft tissue elogation of tight muscles,lower limb resistance exercises,movement transition,balance board standing ,walking and stair climbing Receives: Other: Conventional physiotherapy |
| Group B | Experimental | It included passive soft tissue elongation of tight muscles,lower limb resistance exercises,movement transition,balance board standing ,walking and stair climbing and Vestibular Stimulation exercises such as Swinging in standing in all directions, trampoline jumps, rocking movement in rocking chair, gaze stabilization exercises and visual pursuit exercises under supervision. Receives: Other: Vestibular stimulation with conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross motor
A motor skill is a function, which involves precise movement of muscles with the intent to perform a specific act. Most purposeful movement requires the ability to "feel" or sense what one's muscles are doing as they perform the act. To measure the gross motor, gross motor function classification system is used. Gross motor function measure: The gross motor skill (sitting walking) of children and young people with cerebral palsy can be categorized into different level using a tool called gross motor function classification scale. Gross motor function scale has total of five levels. Level 1 is the lowest while level 5 is the highest. Higher level means worst outcome
Measured: 5 weeks
Balance:
A biological system that enables us to know where our bodies are in the environment and to maintain a desired position. Normal balance depends on information from the inner ear, other senses (such as sight and touch) and muscle movement. To measure the balance, pediatric balance scale is used. Pediatric Balance Scale: The pediatric balance scale is modified version of Berg Balance that is used to assess functional balance skill in school-aged children they have 14 components and a total of 56 score. The minimum score is 0 and 56 is the maximum score. Higher score means good outcome
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start4 Jul 2021
- Primary completion4 Mar 2022 (estimated)
- Study completion4 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotonic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of LahoreThe 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
- study participants will be randomized in two groups,conventional physiotherapy group and intervention group
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- bilal umer, Principal investigator, University of Lahoreanam naz, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162092
- Sponsor's protocol ID
- 893
- Status last verified
- Dec 2021
- First submitted
- 16 Nov 2021
- Last updated
- 17 Dec 2021
- 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 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vestibular Stimulation on Motor Function and Balance in Children With Hypotonic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05162092
- Acronym / sponsor ID
- 893
- Conditions
- Hypotonic Cerebral Palsy
- Keywords
- vestibular stimulation, motor function, balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 4 Jul 2021 (actual)
- Primary completion
- 4 Mar 2022 (estimated)
- Study completion
- 4 Mar 2022 (estimated)
- First posted
- 17 Dec 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.
my study base on 2groups with total sample size 68 patients .group A conventional physiotherapy group in which the duration of session is 30 mints with 5 mints rest .include soft tissue elogation of tight muscles,lowerlimb resistance exercise,movement transitions balance board standing walking and stair climbing.for group b (conventional physiotherapy and vestibular stimulation exercises)30 mints with 10 mints rest.same physiotherpy exercise re given with vestibular stimulation exercises include swinging in standing in all diection,trampoline jump,rocking movement in rocking chair gaze stabilization exercises and visual pursuit exercises
Detailed description
my study base on 2groups with total sample size 68 patients .group A conventional physiotherapy group in which the duration of session is 30 mints with 5 mints rest .include soft tissue elogation of tight muscles,lowerlimb resistance exercise,movement transitions balance board standing walking and stair climbing.for group b (conventional physiotherapy and vestibular stimulation exercises)30 mints with 10 mints rest.same physiotherpy exercise re given with vestibular stimulation exercises include swinging in standing in all diection,trampoline jump,rocking movement in rocking chair gaze stabilization exercises and visual pursuit exercises under supervisio. and use 2 scales,pediatric balance scale and gross motor scale re used for taking data .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- study participants will be randomized in two groups,conventional physiotherapy group and intervention group
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Conventional physiotherapytraining duration for each session is 30 mints with 5 mints rest and it includes passive soft tissue elogation of tight muscles,lower limb resistance exercises,movement transition,balance board standing ,walking and stair climbing |
| Group B | Experimental | Other: Vestibular stimulation with conventional physiotherapyIt included passive soft tissue elongation of tight muscles,lower limb resistance exercises,movement transition,balance board standing ,walking and stair climbing and Vestibular Stimulation exercises such as Swinging in standing in all directions, trampoline jumps, rocking movement in rocking chair, gaze stabilization exercises and visual pursuit exercises under supervision. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- age range from 5-10 years.
- both male/female
- have good head control
- hypotonic cerebral palsy
- able to maintained ring sitting position
Key exclusion criteria (3 listed)
- children will not respond to visual and auditory stimuli due to blindness or deafness or sever mental retardation
- children with un controlled convulsion or vp shunt
- children with severe medical problems children with orthopedic condition
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 |
|---|---|---|
| Conventional physiotherapyParticipants will be given Conventional Physiotherapy. It included Passive Soft tissue elongation of tight muscles, Lower limb resistance exercises, Movement transitions, balance board and foam board standing, walking and stair climbing. | Other | Group A |
| Vestibular stimulation with conventional physiotherapyParticipants in group B will be given conventional physiotherapy and vestibular stimulation exercises. It included conventional is same as given to the conventional and Vestibular Stimulation | Other | Group B |
Primary outcome
Gross motor
Time frame: 5 weeks
A motor skill is a function, which involves precise movement of muscles with the intent to perform a specific act. Most purposeful movement requires the ability to "feel" or sense what one's muscles are doing as they perform the act. To measure the gross motor, gross motor function classification system is used. Gross motor function measure: The gross motor skill (sitting walking) of children and young people with cerebral palsy can be categorized into different level using a tool called gross motor function classification scale. Gross motor function scale has total of five levels. Level 1 is the lowest while level 5 is the highest. Higher level means worst outcome
Balance:
Time frame: 5 weeks
A biological system that enables us to know where our bodies are in the environment and to maintain a desired position. Normal balance depends on information from the inner ear, other senses (such as sight and touch) and muscle movement. To measure the balance, pediatric balance scale is used. Pediatric Balance Scale: The pediatric balance scale is modified version of Berg Balance that is used to assess functional balance skill in school-aged children they have 14 components and a total of 56 score. The minimum score is 0 and 56 is the maximum score. Higher score means good outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Hypotonic Cerebral Palsy
Recruiting
Comparison of Vestibular Stimulation and Core Stability Training on Sitting Balance in Hypotonic CP
Hypotonic Cerebral Palsy
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.
bilal umer principal investigator
University of Lahore
anam naz principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional physiotherapy and Vestibular stimulation with conventional physiotherapy in people with Hypotonic Cerebral Palsy, run by University of Lahore 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 3 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 17 Dec 2021. 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?
Contact Mahwash zulfiqar Khan, msptn (03355077906, zulfiqar1991khan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross motor (time frame: 5 weeks). 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 17 Dec 2021.