Cerebral PalsyNCT05460923
Pelvic Neuromuscular Facilitation and Swiss Ball Exercises on Trunk Control in Children With Diaplegic CP
A study testing Proprioceptive Neuromuscular Facilitation and Swiss Ball Exercises in people with Cerebral Palsy, run by Riphah International University at 2 sites in Pakistan.
Trial summary
Cerebral palsy is an umbrella term that covers a group of non-progressive motor impairment syndromes that are associated with abnormalities in the brain particularly during the early stages of its development. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Proprioceptive Neuromuscular Facilitation and Swiss Ball Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesPakistan
- Study dates
- 25 May 2022to 28 Nov 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with no trunk control
- Age between 5-12 years
- Patients with diplegia
Who cannot join
- Patients with Cognitive impairment
- Patients with comorbidities
- Patients who are unable to follow instructions
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Recruiting
International Therapy Services Center
Lahore, Punjab Province, 40050
wajiha shahid, phd, 03036088768, wajiha.shahid@riphah.edu.pk
Sania Ahmad, MS (PPT)
- Recruiting
Rising Sun Institute
Lahore, Punjab Province, 40050
wajiha shahid, phd, 03036088768, wajiha.shahid@riphah.edu.pk
Sania Ahmad, MS (PPT)
About this study
Official title: Comparison of Pelvic Neuromuscular Facilitation and Swiss Ball Exercises on Trunk Control in Children With Diaplegic Cerebral Palsy
Cerebral palsy is an umbrella term that covers a group of non-progressive motor impairment syndromes that are associated with abnormalities in the brain particularly during the early stages of its development. CP usually involves a number of musculoskeletal and neurological problems they include spasticity, contractures, dystonia, abnormal growth, poor trunk control, and poor balance. Poor trunk control leads to a disturbance in activities of daily living along with postural issues. PNF techniques and Swiss ball exercises target the trunk muscles by stimulating the proprioceptors and by allowing maximum resistance to them respectively. The aim of the study is to do a comparison of Pelvic neuromuscular facilitation techniques and Swiss ball exercises in improving trunk control in children with diplegic cerebral palsy.
Read the detailed description
The studies conducted in the past were focused on finding out the effect of proprioceptive neuromuscular facilitation techniques on the lower extremities of children suffering from diplegic cerebral palsy. The effects of PNF on trunk control the children suffering from diplegic CP are nearly minimal. In addition to PNF, the literature shows that studies have been conducted to find the effects of Swiss ball training exercise on trunk control of the post-stroke patients however there is very little research on the effects of Swiss ball training in children suffering from diplegic CP. Even if the studies are conducted the time duration of the studies are not enough to gain the maximum outcomes.
- Conditions
- Cerebral Palsy
- Being tested
- Proprioceptive Neuromuscular Facilitation, Swiss Ball Exercises
- Keywords
- Cerebral Palsy, Trunk Control Training, Proprioceptive Neuromuscular Facilitation Approach, Swiss ball, Trunk Control Measurement Scale.
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive Neuromuscular FacilitationOther
including trunk twists, supine to sit, knee to chest, crawling, and bridges. Every session will be 45 minutes. Patients will be given 5 sessions per week and the study will last for 12 months
Swiss Ball ExercisesOther
trunk twists, supine to sit, knee to chest, crawling, and bridges. Every session will be 45 minutes. Patients will be given 5 sessions per week and the study will last for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Swiss Ball Exercises | Experimental | Swiss ball exercises along with baseline treatment trunk twists, Receives: Other: Swiss Ball Exercises |
| Proprioceptive Neuromuscular Facilitation | Experimental | pelvic neuromuscular facilitation techniques including various PNF movement patterns along with the baseline treatment Receives: Other: Proprioceptive Neuromuscular Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Control Measurement Scale
The Trunk Control Measurement Scale is a clinical tool that is used in order to measure the trunk control. The scale is used in the areas of assessment of non-vestibular balance and functional mobility
Measured: 8th week
GMFC
The Gross Motor Function Classification System or GMFCS is a 5 level clinical classification system that describes the gross motor function of people with cerebral palsy on the basis of self-initiated movement abilities.
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start25 May 2022
- Primary completion25 Sep 2022 (estimated)
- Study completion28 Nov 2022 (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 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, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wajiha Shahid, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460923
- Sponsor's protocol ID
- REC/RCR & AHS/22/0716
- Status last verified
- Jul 2022
- First submitted
- 14 Jul 2022
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pelvic Neuromuscular Facilitation and Swiss Ball Exercises on Trunk Control in Children With Diaplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05460923
- Acronym / sponsor ID
- REC/RCR & AHS/22/0716
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Trunk Control Training, Proprioceptive Neuromuscular Facilitation Approach, Swiss ball, Trunk Control Measurement Scale.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 25 Sep 2022 (estimated)
- Study completion
- 28 Nov 2022 (estimated)
- First posted
- 15 Jul 2022 (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 is an umbrella term that covers a group of non-progressive motor impairment syndromes that are associated with abnormalities in the brain particularly during the early stages of its development. CP usually involves a number of musculoskeletal and neurological problems they include spasticity, contractures, dystonia, abnormal growth, poor trunk control, and poor balance. Poor trunk control leads to a disturbance in activities of daily living along with postural issues. PNF techniques and Swiss ball exercises target the trunk muscles by stimulating the proprioceptors and by allowing maximum resistance to them respectively. The aim of the study is to do a comparison of Pelvic neuromuscular facilitation techniques and Swiss ball exercises in improving trunk control in children with diplegic cerebral palsy.
Detailed description
The studies conducted in the past were focused on finding out the effect of proprioceptive neuromuscular facilitation techniques on the lower extremities of children suffering from diplegic cerebral palsy. The effects of PNF on trunk control the children suffering from diplegic CP are nearly minimal. In addition to PNF, the literature shows that studies have been conducted to find the effects of Swiss ball training exercise on trunk control of the post-stroke patients however there is very little research on the effects of Swiss ball training in children suffering from diplegic CP. Even if the studies are conducted the time duration of the studies are not enough to gain the maximum outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Swiss Ball Exercises | Experimental | Other: Swiss Ball ExercisesSwiss ball exercises along with baseline treatment trunk twists, |
| Proprioceptive Neuromuscular Facilitation | Experimental | Other: Proprioceptive Neuromuscular Facilitationpelvic neuromuscular facilitation techniques including various PNF movement patterns along with the baseline treatment |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients with no trunk control
- Age between 5-12 years
- Patients with diplegia
Key exclusion criteria (3 listed)
- Patients with Cognitive impairment
- Patients with comorbidities
- Patients who are unable to follow instructions
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 |
|---|---|---|
| Proprioceptive Neuromuscular Facilitationincluding trunk twists, supine to sit, knee to chest, crawling, and bridges. Every session will be 45 minutes. Patients will be given 5 sessions per week and the study will last for 12 months | Other | Proprioceptive Neuromuscular Facilitation |
| Swiss Ball Exercisestrunk twists, supine to sit, knee to chest, crawling, and bridges. Every session will be 45 minutes. Patients will be given 5 sessions per week and the study will last for 12 months | Other | Swiss Ball Exercises |
Primary outcome
Trunk Control Measurement Scale
Time frame: 8th week
The Trunk Control Measurement Scale is a clinical tool that is used in order to measure the trunk control. The scale is used in the areas of assessment of non-vestibular balance and functional mobility
GMFC
Time frame: 8th week
The Gross Motor Function Classification System or GMFCS is a 5 level clinical classification system that describes the gross motor function of people with cerebral palsy on the basis of self-initiated movement abilities.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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.
Wajiha Shahid, PhD principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive Neuromuscular Facilitation and Swiss Ball Exercises in people with Cerebral Palsy, run by Riphah International 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 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 15 Jul 2022. 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?
Contact wajiha shahid, phd (03214885079, wajiha.shahid@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk Control Measurement Scale (time frame: 8th week). 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 15 Jul 2022.