Cerebral PalsyNCT06851117
Compare The Effectiveness of SCT and PNF In Children With Cerebral Palsy
A study testing Proprioceptive Neuromuscular Facilitation (PNF), Spider Cage Therapy Group and Combined PNF and Spider Cage Therapy Group in people with Cerebral Palsy, run by Superior University at 1 site in Pakistan.
Trial summary
This study will evaluate the comparative effectiveness of Spider Cage Therapy (SCT) and Proprioceptive Neuromuscular Facilitation (PNF) in managing motor impairments in children with cerebral palsy (CP). Cerebral palsy often leads to motor deficits that limit movement and impair functionality. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Proprioceptive Neuromuscular Facilitation (PNF), Spider Cage Therapy Group and Combined PNF and Spider Cage Therapy Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Oct 2023to 28 Aug 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4-12 years.
- Clinical diagnosis of cerebral palsy.
- Classified within Gross Motor Function Classification System (GMFCS) levels I to III.
- Ability to follow instructions and participate in therapy sessions.
Who cannot join
- Severe cognitive impairments hindering participation.
- Severe musculoskeletal deformities or recent surgeries.
- Other medical conditions contraindicating participation in physical therapy.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Azra Naheed Medical College, Superior University
Lahore, Punjab Province
About this study
Official title: Compare The Effectiveness of Spider Cage Therapy and Proprioceptive Neuromuscular Facilitation (PNF) In Children With Cerebral Palsy
This study will evaluate the comparative effectiveness of Spider Cage Therapy (SCT) and Proprioceptive Neuromuscular Facilitation (PNF) in managing motor impairments in children with cerebral palsy (CP). Cerebral palsy often leads to motor deficits that limit movement and impair functionality.
Read the detailed description
SCT and PNF are therapeutic interventions that target these motor challenges but use distinct approaches. Spider Cage Therapy will involve the use of elastic cords within a supportive frame (the "spider cage") to stabilize the child, enhancing postural control and enabling dynamic movement training. This approach is expected to improve balance and alignment, promoting functional mobility. In contrast, PNF will focus on neuromuscular reeducation through specific movement patterns intended to enhance strength, coordination, and flexibility. By comparing SCT and PNF, this study aims to identify their respective impacts on motor function improvements, particularly in gross motor skills, balance, and postural stability, potentially guiding future rehabilitation protocols for children with CP.
- Conditions
- Cerebral Palsy
- Being tested
- Proprioceptive Neuromuscular Facilitation (PNF), Spider Cage Therapy Group, Combined PNF and Spider Cage Therapy Group
- 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 Facilitation (PNF)Combination product
Participants in the PNF group will undergo intensive training of the affected limbs for 20 minutes per day, 5 days a week, over a 4-week period. During therapy sessions, the unaffected limb will be constrained using a mitt or cast to encourage focused activation and strengthening of the affected side. The therapy will include repetitive movement patterns designed to enhance strength, flexibility, and coordination.
Spider Cage Therapy GroupCombination product
This group will participate in therapy sessions within the Spider Cage for 20 minutes per day, 5 days a week, for 4 weeks. Interventions will involve weight-bearing exercises, movement facilitation, and balance training, utilizing the cage's elastic cords to support and stabilize posture. The goal is to improve gross motor skills, balance, and controlled movement.
Combined PNF and Spider Cage Therapy GroupDiagnostic test
Participants in this group will receive both PNF and Spider Cage Therapy, with integrated principles and techniques from both approaches. The intensity and duration will be consistent with the individual therapy groups, with sessions held for 20 minutes per day, 5 days a week, over 4 weeks. This combination is expected to enhance functional outcomes by targeting both strength/coordination and balance/postural control.
| Study group | Role | What they receive |
|---|---|---|
| Proprioceptive Neuromuscular Facilitation (PNF) | Experimental | Not described Receives: Combination Product: Proprioceptive Neuromuscular Facilitation (PNF) |
| Spider Cage Therapy Group | Experimental | Not described Receives: Combination Product: Spider Cage Therapy Group |
| Combined PNF and Spider Cage Therapy Group | Active comparator | Not described Receives: Diagnostic Test: Combined PNF and Spider Cage Therapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure (GMFM-66
Five levels and each has different nbr of questions each having 0- 3 score 0 no movement 3 complete movement
Measured: 12 Months
Paedetric balance scale
14 items each have 0-4 score total 56 0 totally dependent 4 independently can prrform movement
Measured: 12 months
Functional Independence Measure for Children (WeeFIM)
for overall functional independence (FIM) it has total 18 items 13 relatesd to mobilty and 5 regarding cognition Each has1- 7 score where reports total dependence and 7 shows complete independence
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 posted28 Feb 2025
- Study start28 Oct 2023
- Primary completion20 Apr 2024
- Study completion28 Aug 2024
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 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
- NCT06851117
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/754
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 28 Feb 2025
- 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 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare The Effectiveness of Spider Cage Therapy and Proprioceptive Neuromuscular Facilitation (PNF) In Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06851117
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/754
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 28 Oct 2023 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 28 Feb 2025 (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.
This study will evaluate the comparative effectiveness of Spider Cage Therapy (SCT) and Proprioceptive Neuromuscular Facilitation (PNF) in managing motor impairments in children with cerebral palsy (CP). Cerebral palsy often leads to motor deficits that limit movement and impair functionality.
Detailed description
SCT and PNF are therapeutic interventions that target these motor challenges but use distinct approaches. Spider Cage Therapy will involve the use of elastic cords within a supportive frame (the "spider cage") to stabilize the child, enhancing postural control and enabling dynamic movement training. This approach is expected to improve balance and alignment, promoting functional mobility. In contrast, PNF will focus on neuromuscular reeducation through specific movement patterns intended to enhance strength, coordination, and flexibility. By comparing SCT and PNF, this study aims to identify their respective impacts on motor function improvements, particularly in gross motor skills, balance, and postural stability, potentially guiding future rehabilitation protocols for children with CP.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive Neuromuscular Facilitation (PNF) | Experimental | Combination Product: Proprioceptive Neuromuscular Facilitation (PNF) |
| Spider Cage Therapy Group | Experimental | Combination Product: Spider Cage Therapy Group |
| Combined PNF and Spider Cage Therapy Group | Active comparator | Diagnostic Test: Combined PNF and Spider Cage Therapy Group |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 4-12 years.
- Clinical diagnosis of cerebral palsy.
- Classified within Gross Motor Function Classification System (GMFCS) levels I to III.
- Ability to follow instructions and participate in therapy sessions.
Key exclusion criteria (3 listed)
- Severe cognitive impairments hindering participation.
- Severe musculoskeletal deformities or recent surgeries.
- Other medical conditions contraindicating participation in physical therapy.
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 Facilitation (PNF)Participants in the PNF group will undergo intensive training of the affected limbs for 20 minutes per day, 5 days a week, over a 4-week period. During therapy sessions, the unaffected limb will be constrained using a mitt or cast to encourage focused activation and strengthening of the affected side. The therapy will include repetitive movement patterns designed to enhance strength, flexibility, and coordination. | Combination product | Proprioceptive Neuromuscular Facilitation (PNF) |
| Spider Cage Therapy GroupThis group will participate in therapy sessions within the Spider Cage for 20 minutes per day, 5 days a week, for 4 weeks. Interventions will involve weight-bearing exercises, movement facilitation, and balance training, utilizing the cage's elastic cords to support and stabilize posture. The goal is to improve gross motor skills, balance, and controlled movement. | Combination product | Spider Cage Therapy Group |
| Combined PNF and Spider Cage Therapy GroupParticipants in this group will receive both PNF and Spider Cage Therapy, with integrated principles and techniques from both approaches. The intensity and duration will be consistent with the individual therapy groups, with sessions held for 20 minutes per day, 5 days a week, over 4 weeks. This combination is expected to enhance functional outcomes by targeting both strength/coordination and balance/postural control. | Diagnostic test | Combined PNF and Spider Cage Therapy Group |
Primary outcome
Gross Motor Function Measure (GMFM-66
Time frame: 12 Months
Five levels and each has different nbr of questions each having 0- 3 score 0 no movement 3 complete movement
Paedetric balance scale
Time frame: 12 months
14 items each have 0-4 score total 56 0 totally dependent 4 independently can prrform movement
Functional Independence Measure for Children (WeeFIM)
Time frame: 12 months
for overall functional independence (FIM) it has total 18 items 13 relatesd to mobilty and 5 regarding cognition Each has1- 7 score where reports total dependence and 7 shows complete independence
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 28 Feb 2025.
- 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.
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 Neuromuscular Facilitation (PNF), Spider Cage Therapy Group and Combined PNF and Spider Cage Therapy Group in people with Cerebral Palsy, run by Superior 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 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: finished, as of the sponsor's last update on 28 Feb 2025. 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 Measure (GMFM-66 (time frame: 12 Months). The study lists 3 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 28 Feb 2025.