CP (Cerebral Palsy)NCT05649501
Effect of PNF on Selective Motor Control and Balance in CP
A study testing Proprioceptive neuromuscular facilitation techniques. and Traditional physical therapy in people with CP (Cerebral Palsy), run by Riphah International University at 1 site in Pakistan.
Trial summary
Cerebral palsy is attributed to non-progressive disturbances that occurred in the developing infant brain or fetal characterized by abnormalities of muscle tone, movement and motor skills. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- CP (Cerebral Palsy)
- What is being tested?
- Proprioceptive neuromuscular facilitation techniques. and Traditional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2022to 15 Jan 2023
- 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
- Children diagnosed as spastic diplegic cerebral palsy
- Age between 5-12 years and both genders.
- Gross motor function level II and III according to gross motor functional classification scale (GMFCS).
- Spasticity range between 1 and 1+ grade according to modified ashworth scale
- Children who are able to follow simple verbal instructions
Who cannot join
- Children with uncontrolled epilepsy
- Children who show no cooperation
- Children receiving botulinum toxin injections or surgery no earlier than 6 months before project starts.
- Subjects with presence of shortening or deformities of lower limb
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Society for Rehabilitation of the Disabled (PSRD)
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Proprioceptive Neuromuscular Facilitation on Selective Motor Control of Lower Extremity and Balance in Children With Cerebral Palsy
Cerebral palsy is attributed to non-progressive disturbances that occurred in the developing infant brain or fetal characterized by abnormalities of muscle tone, movement and motor skills. PNF technique is thought to have an impact on voluntary motor control and balance through stimulation of proprioceptors, so the aim of this study is to determine the effects of proprioceptive neuromuscular facilitation technique on selective motor control and balance on children with cerebral palsy.
Read the detailed description
A case study was conducted in 2021 to determine the effects of PNF training for improving lower limb coordination in 7 years old cerebral palsy child. After the intervention, significant improvement is seen in gait parameters, balance, and gross motor functional classification score.
A case report was conducted in 2020, to determine the effectiveness of PNF technique in improving lower extremity function in spastic diplegic cerebral palsied adolescent. Patient was treated with tone inhibitory and movement facilitatory techniques. There was significant change in balance and lower extremity function before and after the treatment.
There are multiple impairments in spastic cerebral palsy children; the inability to perform purposeful voluntary movements is a critical factor in determining functional ability of children. Since selective voluntary motor control is an important factor that must be achieved in cerebral palsy children, PNF may be considered as a technique to gain selective voluntary control and balance proving an important intervention for cerebral palsy children.
- Conditions
- CP (Cerebral Palsy)
- Being tested
- Proprioceptive neuromuscular facilitation techniques., Traditional physical therapy
- Keywords
- Proprioceptive neuromuscular techniques, Selective voluntary motor control, 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.
Proprioceptive neuromuscular facilitation techniques.Other
Proprioceptive neuromuscular facilitation stretching which include hold-relax and contract-relax for 6 sec hold, 10 repetitions and 2 min rest in between, for 5 day/week for 4 weeks along with conventional treatment for 40 minutes.
Traditional physical therapyOther
Conventional therapy (ROMs, stretching, strengthening) of lower limbs for 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| proprioceptive neuromuscular facilitation techniques | Experimental | Experimental group will receive proprioceptive neuromuscular facilitation stretching which include hold-relax and contract-relax for 6 sec hold, 10 repetitions and 2 min rest in between, for 5 day/week for 4 weeks along with conventional physical therapy. Receives: Other: Proprioceptive neuromuscular facilitation techniques. |
| traditional physical therapy | Active comparator | this group will receive conventional therapy (ROMs, stretching, strengthening). Receives: Other: Proprioceptive neuromuscular facilitation techniques.; Other: Traditional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Berg Balance Scale
The Pediatric Balance Scale (PBS), a modification of Berg's Balance Scale, was developed as a balance measure for school-age children with mild to moderate motor impairments. It has 14 items with score 0-4. The intra-class correlation coefficient (ICC) is 0.998 (18).
Measured: last one week
Secondary outcomes (1)
Selective control assessment of lower extremity (SCALE)
The SCALE tool was designed for clinical administration and scoring by healthcare professionals, to be used in less than 15 minutes without specialized equipment. Hip, knee, ankle, subtalar, and toe joints are assessed bilaterally. One representative reciprocal movement that varies from the mass flexor/extensor patterns is chosen to assess SVMC for each joint. Total score is 10 for each limb. Intra-class correlation coefficient ranges from 0.88 to 0.91 (19).
Measured: last one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Feb 2022
- Primary completion15 Jan 2023
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CP (Cerebral Palsy)Studies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shabana Ashraf, Masters, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649501
- Sponsor's protocol ID
- REC/22/0725 Misbah Tahir
- Status last verified
- Mar 2023
- First submitted
- 6 Dec 2022
- Last updated
- 3 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mutch L, Alberman E, Hagberg B, Kodama K, Perat MV. Cerebral palsy epidemiology: where are we now and where are we going? Dev Med Child Neurol. 1992 Jun;34(6):547-51. doi: 10.1111/j.1469-8749.1992.tb11479.x. No abstract available.
PubMed 1612216Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. doi: 10.1017/s001216220500112x.
PubMed 16108461Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
PubMed 17370477Tang-Wai R, Webster RI, Shevell MI. A clinical and etiologic profile of spastic diplegia. Pediatr Neurol. 2006 Mar;34(3):212-8. doi: 10.1016/j.pediatrneurol.2005.08.027.
PubMed 1650479115. Akalan E, Ertürk G, Önerge K, Evrendirek H, Karaca G. Investigation of the Relationship Between Selective Voluntary Motor Control and Static Balance in Cerebral Palsy. 2019.
Franjoine MR, Darr N, Held SL, Kott K, Young BL. The performance of children developing typically on the pediatric balance scale. Pediatr Phys Ther. 2010 Winter;22(4):350-9. doi: 10.1097/PEP.0b013e3181f9d5eb.
PubMed 21068635Balzer J, Marsico P, Mitteregger E, van der Linden ML, Mercer TH, van Hedel HJ. Construct validity and reliability of the Selective Control Assessment of the Lower Extremity in children with cerebral palsy. Dev Med Child Neurol. 2016 Feb;58(2):167-72. doi: 10.1111/dmcn.12805. Epub 2015 May 20.
PubMed 25991061
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Proprioceptive Neuromuscular Facilitation on Selective Motor Control of Lower Extremity and Balance in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05649501
- Acronym / sponsor ID
- REC/22/0725 Misbah Tahir
- Conditions
- CP (Cerebral Palsy)
- Keywords
- Proprioceptive neuromuscular techniques, Selective voluntary motor control, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 14 Dec 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 attributed to non-progressive disturbances that occurred in the developing infant brain or fetal characterized by abnormalities of muscle tone, movement and motor skills. PNF technique is thought to have an impact on voluntary motor control and balance through stimulation of proprioceptors, so the aim of this study is to determine the effects of proprioceptive neuromuscular facilitation technique on selective motor control and balance on children with cerebral palsy.
Detailed description
A case study was conducted in 2021 to determine the effects of PNF training for improving lower limb coordination in 7 years old cerebral palsy child. After the intervention, significant improvement is seen in gait parameters, balance, and gross motor functional classification score.
A case report was conducted in 2020, to determine the effectiveness of PNF technique in improving lower extremity function in spastic diplegic cerebral palsied adolescent. Patient was treated with tone inhibitory and movement facilitatory techniques. There was significant change in balance and lower extremity function before and after the treatment.
There are multiple impairments in spastic cerebral palsy children; the inability to perform purposeful voluntary movements is a critical factor in determining functional ability of children. Since selective voluntary motor control is an important factor that must be achieved in cerebral palsy children, PNF may be considered as a technique to gain selective voluntary control and balance proving an important intervention for cerebral palsy children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| proprioceptive neuromuscular facilitation techniques | Experimental | Other: Proprioceptive neuromuscular facilitation techniques.Experimental group will receive proprioceptive neuromuscular facilitation stretching which include hold-relax and contract-relax for 6 sec hold, 10 repetitions and 2 min rest in between, for 5 day/week for 4 weeks along with conventional physical therapy. |
| traditional physical therapy | Active comparator | Other: Proprioceptive neuromuscular facilitation techniques., Other: Traditional physical therapythis group will receive conventional therapy (ROMs, stretching, strengthening). |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children diagnosed as spastic diplegic cerebral palsy
- Age between 5-12 years and both genders.
- Gross motor function level II and III according to gross motor functional classification scale (GMFCS).
- Spasticity range between 1 and 1+ grade according to modified ashworth scale
- Children who are able to follow simple verbal instructions
Key exclusion criteria (4 listed)
- Children with uncontrolled epilepsy
- Children who show no cooperation
- Children receiving botulinum toxin injections or surgery no earlier than 6 months before project starts.
- Subjects with presence of shortening or deformities of lower limb
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 techniques.Proprioceptive neuromuscular facilitation stretching which include hold-relax and contract-relax for 6 sec hold, 10 repetitions and 2 min rest in between, for 5 day/week for 4 weeks along with conventional treatment for 40 minutes. | Other | proprioceptive neuromuscular facilitation techniques, traditional physical therapy |
| Traditional physical therapyConventional therapy (ROMs, stretching, strengthening) of lower limbs for 40 minutes. | Other | traditional physical therapy |
Primary outcome
Pediatric Berg Balance Scale
Time frame: last one week
The Pediatric Balance Scale (PBS), a modification of Berg's Balance Scale, was developed as a balance measure for school-age children with mild to moderate motor impairments. It has 14 items with score 0-4. The intra-class correlation coefficient (ICC) is 0.998 (18).
1 secondary outcome
Selective control assessment of lower extremity (SCALE)
Time frame: last one week
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 3 Apr 2023.
- Background: PubMed 1612216Mutch L, Alberman E, Hagberg B, Kodama K, Perat MV. Cerebral palsy epidemiology: where are we now and where are we going? Dev Med Child Neurol. 1992 Jun;34(6):547-51. doi: 10.1111/j.1469-8749.1992.tb11479.x. No abstract available.
- Background: PubMed 16108461Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. doi: 10.1017/s001216220500112x.
- Background: PubMed 17370477Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
- Background: PubMed 16504791Tang-Wai R, Webster RI, Shevell MI. A clinical and etiologic profile of spastic diplegia. Pediatr Neurol. 2006 Mar;34(3):212-8. doi: 10.1016/j.pediatrneurol.2005.08.027.
- Background15. Akalan E, Ertürk G, Önerge K, Evrendirek H, Karaca G. Investigation of the Relationship Between Selective Voluntary Motor Control and Static Balance in Cerebral Palsy. 2019.
- Background: PubMed 21068635Franjoine MR, Darr N, Held SL, Kott K, Young BL. The performance of children developing typically on the pediatric balance scale. Pediatr Phys Ther. 2010 Winter;22(4):350-9. doi: 10.1097/PEP.0b013e3181f9d5eb.
- Background: PubMed 25991061Balzer J, Marsico P, Mitteregger E, van der Linden ML, Mercer TH, van Hedel HJ. Construct validity and reliability of the Selective Control Assessment of the Lower Extremity in children with cerebral palsy. Dev Med Child Neurol. 2016 Feb;58(2):167-72. doi: 10.1111/dmcn.12805. Epub 2015 May 20.
- 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.
Shabana Ashraf, Masters 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 Proprioceptive neuromuscular facilitation techniques. and Traditional physical therapy in people with CP (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 5 inclusion and 4 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 3 Apr 2023. 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?
Pediatric Berg Balance Scale (time frame: last one week). 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 NCT05649501, which also lists 7 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 3 Apr 2023.