Cerebral PalsyNCT05436847
Effects of Proprioceptive Training With Routine PT on Gross Motor Function in Spastic Quadriplegic CP
A study testing Proprioceptive Training and Routine Physical Therapy in people with Cerebral Palsy, run by University of Lahore at 1 site in Pakistan.
Trial summary
The proprioceptive training with a therapy regime enhances the body's somatosensory input that in result changes the body to be more functional in different types of interactions. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Proprioceptive Training and Routine Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2021to 10 Jun 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 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with the diagnosis of Cerebral Palsy (Spastic quadriplegia)
- Ages of 1 to 5 years
- Both males and females
- Alert and responsive to verbal and non-verbal commands
- Modified Ashworth Sale grade 1 to 2
- Gross Motor Function Classification System level 1V and V
Who cannot join
- Children under the botox treatment for tone management (botulinum injections)
- Diagnosed with any disease other than spastic quadriplegic cerebral palsy i.e. congenital heart defects, epilepsy, recurrent pneumonia, skin infections etc.
- Children underwent any surgery i.e. tenotomy (tendon release), recent heart surgery,
- Recent fracture and subluxation/dislocation due to fall or poor handling
- Any contracture or deformity on upper extremities, lower extremities and spine i.e. flexion contractures, club foot, scoliosis
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
The University of Lahore Teaching Hospital
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Proprioceptive Training in Addition to Routine Physical Therapy on Gross Motor Function in Children With Spastic Quadriplegic Cerebral Palsy: A Randomized Control Trial
The proprioceptive training with a therapy regime enhances the body's somatosensory input that in result changes the body to be more functional in different types of interactions. This study is dedicated to finding out how much proprioception training is helpful in gross motor function level improvement and enhances functional activities of CP children
Read the detailed description
Proprioception plays an important role in the correct execution of efferent motor performance as 70% of cerebral palsy population have deficit in receiving somatosensory signals3. Tradition physical therapy exercises including strengthening followed by stretching etc. should be reviewed and the therapy must be more oriented to overall individual growth and development31. There is a need to push the cerebral palsy population to be exercised with proprioceptive stimulation for their maximum participation in the activities of daily life including both personal and social aspects. The proprioceptive training with a therapy regime enhances the body's somatosensory input that in result changes the body to be more functional in different types of interactions. This study is dedicated to finding out how much proprioception training is helpful in gross motor function level improvement and enhances functional activities of CP children.
- Conditions
- Cerebral Palsy
- Being tested
- Proprioceptive Training, Routine Physical Therapy
- Keywords
- : Spastic Quadriplegia, Cerebral palsy, Proprioceptive training, Somatosensory input
- Medical subject headings
- Cerebral Palsy, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive TrainingOther
Proprioceptive Training using increased joint to joint approximation through ankle weights and joint splints.
Routine Physical TherapyOther
Neurodevelopmental treatment- age appropriate
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | NDT- age appropriate Transitions (age appropriate) Milestones training (age appropriate) Proprioceptive Input- age appropriate (Pushups Static quadruped, squat sitting, trampoline, hopping etc. With weights and splints for joint to joint approximation) Receives: Other: Proprioceptive Training |
| Group B | Active comparator | NDT- age appropriate Transitions (age appropriate) Milestones training (age appropriate) Receives: Other: Routine Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function
Gross Motor Function Classification System (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. Higher scores indicate better improvement in gross motor functions.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Dec 2021
- Primary completion30 May 2022
- Study completion10 Jun 2022
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 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Jawad, MSPTN, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436847
- Sponsor's protocol ID
- IRB-UOL-FAHS/831-VI/2021
- Status last verified
- Jun 2022
- First submitted
- 23 Jun 2022
- Last updated
- 29 Jun 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 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Proprioceptive Training in Addition to Routine Physical Therapy on Gross Motor Function in Children With Spastic Quadriplegic Cerebral Palsy: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05436847
- Acronym / sponsor ID
- IRB-UOL-FAHS/831-VI/2021
- Conditions
- Cerebral Palsy
- Keywords
- : Spastic Quadriplegia, Cerebral palsy, Proprioceptive training, Somatosensory input
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 29 Jun 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.
The proprioceptive training with a therapy regime enhances the body's somatosensory input that in result changes the body to be more functional in different types of interactions. This study is dedicated to finding out how much proprioception training is helpful in gross motor function level improvement and enhances functional activities of CP children
Detailed description
Proprioception plays an important role in the correct execution of efferent motor performance as 70% of cerebral palsy population have deficit in receiving somatosensory signals3. Tradition physical therapy exercises including strengthening followed by stretching etc. should be reviewed and the therapy must be more oriented to overall individual growth and development31. There is a need to push the cerebral palsy population to be exercised with proprioceptive stimulation for their maximum participation in the activities of daily life including both personal and social aspects. The proprioceptive training with a therapy regime enhances the body's somatosensory input that in result changes the body to be more functional in different types of interactions. This study is dedicated to finding out how much proprioception training is helpful in gross motor function level improvement and enhances functional activities of CP children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Proprioceptive TrainingNDT- age appropriate Transitions (age appropriate) Milestones training (age appropriate) Proprioceptive Input- age appropriate (Pushups Static quadruped, squat sitting, trampoline, hopping etc. With weights and splints for joint to joint approximation) |
| Group B | Active comparator | Other: Routine Physical TherapyNDT- age appropriate Transitions (age appropriate) Milestones training (age appropriate) |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children with the diagnosis of Cerebral Palsy (Spastic quadriplegia)
- Ages of 1 to 5 years
- Both males and females
- Alert and responsive to verbal and non-verbal commands
- Modified Ashworth Sale grade 1 to 2
Key exclusion criteria (5 listed)
- Children under the botox treatment for tone management (botulinum injections)
- Diagnosed with any disease other than spastic quadriplegic cerebral palsy i.e. congenital heart defects, epilepsy, recurrent pneumonia, skin infections etc.
- Children underwent any surgery i.e. tenotomy (tendon release), recent heart surgery,
- Recent fracture and subluxation/dislocation due to fall or poor handling
- Any contracture or deformity on upper extremities, lower extremities and spine i.e. flexion contractures, club foot, scoliosis
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 TrainingProprioceptive Training using increased joint to joint approximation through ankle weights and joint splints. | Other | Group A |
| Routine Physical TherapyNeurodevelopmental treatment- age appropriate | Other | Group B |
Primary outcome
Gross Motor Function
Time frame: 9 months
Gross Motor Function Classification System (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. Higher scores indicate better improvement in gross motor functions.
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 29 Jun 2022.
- 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.
Muhammad Jawad, MSPTN 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 Proprioceptive Training and Routine Physical Therapy in people with 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 6 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 29 Jun 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?
Gross Motor Function (time frame: 9 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 29 Jun 2022.