Cerebral Palsy (CP)NCT06696989
Comparative Effects of Frenkel's and Core Stability Exercises in Children With Cerebral Palsy
A study testing Frenkel's exercises and Core stability exercises in people with Cerebral Palsy (CP), run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to determine and compare the effects of Frenkel's and core stability exercises on the motor function, postural stability and core muscle strength in children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Frenkel's exercises and Core stability exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Oct 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The participants fulfilling the given criteria will be included.
- Age: 6 To 12 Years
- Gender: Both male and female
- Children with ataxic cerebral palsy
- Children having level II and III on Gross Motor Functional Classification System (GMFCS)
- Children able to understand the test instruction, able to sit and stand.
- Children with and without using Botulinum Toxin Injections
- The Pediatric Balance Scale (PBS) of 54.6
Who cannot join
- Severe Cognitive Dysfunction
- Visual problems
- Vestibular Dysfunction
- Uncontrolled epilepsy
- Severe Orthopedic Condition affecting Lower limbs Mobility
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Effects of Frenkel's and Core Stability Exercises on Coordination and Balance in Children With Cerebral Palsy
The aim of this study is to determine and compare the effects of Frenkel's and core stability exercises on the motor function, postural stability and core muscle strength in children with cerebral palsy.
Read the detailed description
Cerebral palsy (CP) is a brain injury that manifests as a mobility and posture impairment in infancy or early childhood. Frenkel exercises are series of movements with increasing difficulty that can be performed by ataxic patients in order to regain coordinated, smooth and rhythmic movement. The Core stability Exercises are for the spine, pelvis, and kinetic chain to all balance properly under stress, core stability is necessary. The aim of this study is to determine and compare the effects of Frenkel's and core stability exercises on the motor function, postural stability and core muscle strength in children with cerebral palsy. This will be a Randomized Clinical Trial in which 50 participants with cerebral palsy will be included as per sample size calculation through non probability convenience sampling technique. The study will be single blinded. Participants that achieve the required standards of inclusion and exclusion criteria will be randomly allocated using online randomization tool into two Groups. Group A will receive Frenkel's exercises and Group B will receive core stability exercises, both groups will receive the treatment for 40 minutes with the routine physical therapy for 20 minutes and short-term rest intervals in between for 3 alternative days per week for 12 weeks. Participants initial screening will be done through Gross Motor Function Classification System (GMFCS). The balance will be assessed through the Pediatric Balance Test (PBS), coordination will be assessed through Finger and Nose Test, Heel Shin Test, Catching and Throwing Tasks.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Frenkel's exercises, Core stability exercises
- Keywords
- Cerebral Palsy, Core Stability, Balance, Frenkel exercises
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frenkel's exercisesOther
In this group, participants will receive Frenkel's exercises, and the total treatment session will be 60 minutes of routine physical therapy, i.e., breathing, stretching, ROM's, and joint mobility, with rest intervals in between for 20 minutes. To begin the intervention, the investigator will perform Frenkel's exercises for 40 minutes in total, with rest intervals between each exercise, initially performing 5 repetitions and then gradually progressing to 10 and then 15 repetitions, respectively, after 2 weeks.
Core stability exercisesOther
This group participants will receive core stability exercises, and the total treatment session will also be 60 minutes. The routine physical therapy includes breathing, stretching, joint rotations, ROM's, and frequent periods of rest in between the treatment sessions. To begin the intervention the investigator will perform core stability exercises for 40 minutes in total with rest intervals between each exercise and initially performing 5 repetitions and then gradually progressing to 10 and then 15 repetitions, respectively after 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A ( Frenkel's exercises) | Experimental | In this group, participants will receive Frenkel's exercises for the lower limb in lying, sitting, and standing positions. And for the upper limb. Receives: Other: Frenkel's exercises |
| Group B (Core Stability Exercises) | Experimental | Participants will receive core stability exercises, i.e., abdominal draw-in, roll-up, superman, and bridging. Receives: Other: Core stability exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finger to nose test
The Finger-to-Nose Test measures smooth, coordinated upper-extremity movement by having the examinee touch the tip of his or her nose with his or her index finger. Evaluation of coordination with the Finger-Nose Test is an essential part of the neurological examination
Measured: 12th week
Heel shin test
The heel-shin test is a part of the neurological examination of coordination: the patient runs the sole of one foot up and down the shin of the opposite leg.
Measured: 12th week
Catching and throwing tasks
Ball catching is a skill included in most tests for assessing the motor impairment of children with a mild motor deficit. To objectively measure ball catching short and long ball catching tests were developed to assess children between seven and nine years of age
Measured: 12th week
PBS (Pediatric Ballance Scale)
A modified version of the Berg Balance Scale, the Pediatric Balance Scale is used to evaluate school-age children's functional balance abilities. The 14 items on the scale have a maximum score of 56 points and are rated from 0 (lowest function) to 4 (highest function).
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start24 Oct 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, Phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696989
- Sponsor's protocol ID
- REC/RCR&AHS/24/0240
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kang H. Sample size determination and power analysis using the G*Power software. J Educ Eval Health Prof. 2021;18:17. doi: 10.3352/jeehp.2021.18.17. Epub 2021 Jul 30.
PubMed 34325496Hlaing SS, Puntumetakul R, Khine EE, Boucaut R. Effects of core stabilization exercise and strengthening exercise on proprioception, balance, muscle thickness and pain related outcomes in patients with subacute nonspecific low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2021 Nov 30;22(1):998. doi: 10.1186/s12891-021-04858-6.
PubMed 34847915Abd-Elfattah HM, Aly SM. Effect of Core Stability Exercises on Hand Functions in Children With Hemiplegic Cerebral Palsy. Ann Rehabil Med. 2021 Feb;45(1):71-78. doi: 10.5535/arm.20124. Epub 2021 Feb 9.
PubMed 33557483Ali MS, Awad AS, Elassal MI. The effect of two therapeutic interventions on balance in children with spastic cerebral palsy: A comparative study. J Taibah Univ Med Sci. 2019 Jul 26;14(4):350-356. doi: 10.1016/j.jtumed.2019.05.005. eCollection 2019 Aug.
PubMed 31488967Manko G, Pieniazek M, Tim S, Jekielek M. The Effect of Frankel's Stabilization Exercises and Stabilometric Platform in the Balance in Elderly Patients: A Randomized Clinical Trial. Medicina (Kaunas). 2019 Sep 11;55(9):583. doi: 10.3390/medicina55090583.
PubMed 31514453Horber V, Fares A, Platt MJ, Arnaud C, Krageloh-Mann I, Sellier E. Severity of Cerebral Palsy-The Impact of Associated Impairments. Neuropediatrics. 2020 Apr;51(2):120-128. doi: 10.1055/s-0040-1701669. Epub 2020 Mar 2.
PubMed 32120428Graham D, Paget SP, Wimalasundera N. Current thinking in the health care management of children with cerebral palsy. Med J Aust. 2019 Feb;210(3):129-135. doi: 10.5694/mja2.12106. Epub 2019 Feb 10.
PubMed 30739332Paul S, Nahar A, Bhagawati M, Kunwar AJ. A Review on Recent Advances of Cerebral Palsy. Oxid Med Cell Longev. 2022 Jul 30;2022:2622310. doi: 10.1155/2022/2622310. eCollection 2022.
PubMed 35941906Khan SA, Talat S, Malik MI. Risk factors, types, and neuroimaging findings in Children with Cerebral Palsy. Pak J Med Sci. 2022 Sep-Oct;38(7):1738-1742. doi: 10.12669/pjms.38.7.6175.
PubMed 36246690
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Frenkel's and Core Stability Exercises on Coordination and Balance in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06696989
- Acronym / sponsor ID
- REC/RCR&AHS/24/0240
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Cerebral Palsy, Core Stability, Balance, Frenkel exercises
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 20 Nov 2024 (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 aim of this study is to determine and compare the effects of Frenkel's and core stability exercises on the motor function, postural stability and core muscle strength in children with cerebral palsy.
Detailed description
Cerebral palsy (CP) is a brain injury that manifests as a mobility and posture impairment in infancy or early childhood. Frenkel exercises are series of movements with increasing difficulty that can be performed by ataxic patients in order to regain coordinated, smooth and rhythmic movement. The Core stability Exercises are for the spine, pelvis, and kinetic chain to all balance properly under stress, core stability is necessary. The aim of this study is to determine and compare the effects of Frenkel's and core stability exercises on the motor function, postural stability and core muscle strength in children with cerebral palsy. This will be a Randomized Clinical Trial in which 50 participants with cerebral palsy will be included as per sample size calculation through non probability convenience sampling technique. The study will be single blinded. Participants that achieve the required standards of inclusion and exclusion criteria will be randomly allocated using online randomization tool into two Groups. Group A will receive Frenkel's exercises and Group B will receive core stability exercises, both groups will receive the treatment for 40 minutes with the routine physical therapy for 20 minutes and short-term rest intervals in between for 3 alternative days per week for 12 weeks. Participants initial screening will be done through Gross Motor Function Classification System (GMFCS). The balance will be assessed through the Pediatric Balance Test (PBS), coordination will be assessed through Finger and Nose Test, Heel Shin Test, Catching and Throwing Tasks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A ( Frenkel's exercises) | Experimental | Other: Frenkel's exercisesIn this group, participants will receive Frenkel's exercises for the lower limb in lying, sitting, and standing positions. And for the upper limb. |
| Group B (Core Stability Exercises) | Experimental | Other: Core stability exercisesParticipants will receive core stability exercises, i.e., abdominal draw-in, roll-up, superman, and bridging. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- The participants fulfilling the given criteria will be included.
- Age: 6 To 12 Years
- Gender: Both male and female
- Children with ataxic cerebral palsy
- Children having level II and III on Gross Motor Functional Classification System (GMFCS)
Key exclusion criteria (5 listed)
- Severe Cognitive Dysfunction
- Visual problems
- Vestibular Dysfunction
- Uncontrolled epilepsy
- Severe Orthopedic Condition affecting Lower limbs Mobility
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 |
|---|---|---|
| Frenkel's exercisesIn this group, participants will receive Frenkel's exercises, and the total treatment session will be 60 minutes of routine physical therapy, i.e., breathing, stretching, ROM's, and joint mobility, with rest intervals in between for 20 minutes. To begin the intervention, the investigator will perform Frenkel's exercises for 40 minutes in total, with rest intervals between each exercise, initially performing 5 repetitions and then gradually progressing to 10 and then 15 repetitions, respectively, after 2 weeks. | Other | Group A ( Frenkel's exercises) |
| Core stability exercisesThis group participants will receive core stability exercises, and the total treatment session will also be 60 minutes. The routine physical therapy includes breathing, stretching, joint rotations, ROM's, and frequent periods of rest in between the treatment sessions. To begin the intervention the investigator will perform core stability exercises for 40 minutes in total with rest intervals between each exercise and initially performing 5 repetitions and then gradually progressing to 10 and then 15 repetitions, respectively after 2 weeks. | Other | Group B (Core Stability Exercises) |
Primary outcome
Finger to nose test
Time frame: 12th week
The Finger-to-Nose Test measures smooth, coordinated upper-extremity movement by having the examinee touch the tip of his or her nose with his or her index finger. Evaluation of coordination with the Finger-Nose Test is an essential part of the neurological examination
Heel shin test
Time frame: 12th week
The heel-shin test is a part of the neurological examination of coordination: the patient runs the sole of one foot up and down the shin of the opposite leg.
Catching and throwing tasks
Time frame: 12th week
Ball catching is a skill included in most tests for assessing the motor impairment of children with a mild motor deficit. To objectively measure ball catching short and long ball catching tests were developed to assess children between seven and nine years of age
PBS (Pediatric Ballance Scale)
Time frame: 12th week
A modified version of the Berg Balance Scale, the Pediatric Balance Scale is used to evaluate school-age children's functional balance abilities. The 14 items on the scale have a maximum score of 56 points and are rated from 0 (lowest function) to 4 (highest function).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Background: PubMed 34325496Kang H. Sample size determination and power analysis using the G*Power software. J Educ Eval Health Prof. 2021;18:17. doi: 10.3352/jeehp.2021.18.17. Epub 2021 Jul 30.
- Background: PubMed 34847915Hlaing SS, Puntumetakul R, Khine EE, Boucaut R. Effects of core stabilization exercise and strengthening exercise on proprioception, balance, muscle thickness and pain related outcomes in patients with subacute nonspecific low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2021 Nov 30;22(1):998. doi: 10.1186/s12891-021-04858-6.
- Background: PubMed 33557483Abd-Elfattah HM, Aly SM. Effect of Core Stability Exercises on Hand Functions in Children With Hemiplegic Cerebral Palsy. Ann Rehabil Med. 2021 Feb;45(1):71-78. doi: 10.5535/arm.20124. Epub 2021 Feb 9.
- Background: PubMed 31488967Ali MS, Awad AS, Elassal MI. The effect of two therapeutic interventions on balance in children with spastic cerebral palsy: A comparative study. J Taibah Univ Med Sci. 2019 Jul 26;14(4):350-356. doi: 10.1016/j.jtumed.2019.05.005. eCollection 2019 Aug.
- Background: PubMed 31514453Manko G, Pieniazek M, Tim S, Jekielek M. The Effect of Frankel's Stabilization Exercises and Stabilometric Platform in the Balance in Elderly Patients: A Randomized Clinical Trial. Medicina (Kaunas). 2019 Sep 11;55(9):583. doi: 10.3390/medicina55090583.
- Background: PubMed 32120428Horber V, Fares A, Platt MJ, Arnaud C, Krageloh-Mann I, Sellier E. Severity of Cerebral Palsy-The Impact of Associated Impairments. Neuropediatrics. 2020 Apr;51(2):120-128. doi: 10.1055/s-0040-1701669. Epub 2020 Mar 2.
- Background: PubMed 30739332Graham D, Paget SP, Wimalasundera N. Current thinking in the health care management of children with cerebral palsy. Med J Aust. 2019 Feb;210(3):129-135. doi: 10.5694/mja2.12106. Epub 2019 Feb 10.
- Background: PubMed 35941906Paul S, Nahar A, Bhagawati M, Kunwar AJ. A Review on Recent Advances of Cerebral Palsy. Oxid Med Cell Longev. 2022 Jul 30;2022:2622310. doi: 10.1155/2022/2622310. eCollection 2022.
- Background: PubMed 36246690Khan SA, Talat S, Malik MI. Risk factors, types, and neuroimaging findings in Children with Cerebral Palsy. Pak J Med Sci. 2022 Sep-Oct;38(7):1738-1742. doi: 10.12669/pjms.38.7.6175.
- 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.
Aruba Saeed, Phd 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 Frenkel's exercises and Core stability exercises in people with Cerebral Palsy (CP), 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 8 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: enrolling by invitation, as of the sponsor's last update on 20 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Finger to nose test (time frame: 12th week). The study lists 4 primary outcomes in all. 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 NCT06696989, which also lists 9 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 20 Nov 2024.