Cerebral PalsyNCT06673797
Effects of Swiss Ball vs Frenkle Exercises on Static and Dynamic Balance in Ataxic CP
A study testing Effects of Swiss Ball exercises and EFFECTS OF FRENKEL EXERCISES ON STATIC AND DYNAMIC BALANCE IN ATAXIC CHILDREN WITH CEREBRAL PALSY in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Several studies have highlighted the significant impact of cerebral palsy, a prevailing neurological and musculoskeletal developmental disorder among childhood disabilities worldwide. Within the spectrum of cerebral palsy, ataxic CP stands as the least prevalent type, accounting for 5 to 10% of all cases. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Effects of Swiss Ball exercises and EFFECTS OF FRENKEL EXERCISES ON STATIC AND DYNAMIC BALANCE IN ATAXIC CHILDREN WITH CEREBRAL PALSY
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Sep 2024to 10 Dec 2024
- 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with having diagnosis of ataxic cerebral palsy
- Age between 5 to 8 years.
- GMFC level 2.
- Both the genders were included
Who cannot join
- Visual Impairments and hearing loss
- Mental retardation
- Fixed contractures or deformities of the spine or extremities
- Meningitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah international university
Lahore, Punjab Province, 54700
Imran Amjad, PhD, 9233224390125, Imran.amjad@riphah.edu.pk
Muhammad Asif Javed, MS, 03224209422, a.javed@riphah.edu.pk
About this study
Official title: Effects of Swiss Ball vs Frenkle Exercises on Static and Dynamic Balance in Ataxic Children With Cerebral Palsy
Several studies have highlighted the significant impact of cerebral palsy, a prevailing neurological and musculoskeletal developmental disorder among childhood disabilities worldwide. Within the spectrum of cerebral palsy, ataxic CP stands as the least prevalent type, accounting for 5 to 10% of all cases. Individuals diagnosed with ataxic CP encounter difficulties in fine motor skills, precision, and coordination, and exhibit an unsteady gait, some of which are linked to compromised postural control and inadequate core stability. These issues culminate in functional limitations, heightening the risk of falls, and further contributing to the overall disability experienced by the patients. Consequently, there exists a need to prioritize research and develop targeted treatment protocols specifically for ataxic CP. It is crucial to emphasize the enhancement of postural control and coordination, with particular emphasis on improving static and dynamic balance during rehabilitation. Implementing Swiss ball exercises and Frenkel exercises in the rehabilitation protocol for children with ataxic cerebral palsy can significantly diversify treatment strategies. These exercises play a pivotal role in supporting these children to either sustain or regain their ability to function independently, reduce the risk of falls, and notably improve their overall well-being.
Read the detailed description
A four-week randomized clinical trial will involve 18 participants, divided randomly into two intervention groups, with nine participants in each group. Group A (intervention group 1) will participate in Swiss ball exercises combined with stretching, while Group B (intervention group 2) will partake in Frenkel exercises along with stretching. The sampling method employed will be a non-probability technique. The Pediatric Balance Scale (PBS) will serve as the primary tool for outcome measurement. Randomization will be conducted using computer-generated software. The study design will be single-blinded, ensuring the assessor remains unaware of the groups\' assignments. Initial data collection (pretest) will occur at week 0, followed by post-test data collection at week 4. For intergroup analysis, if the data follows a normal distribution, the parametric Independent t-test will be utilized, enabling the calculation of mean, standard deviation, and p-values. Alternatively, if the data does not display a normal distribution, the non-parametric Mann-Whitney test will be employed, allowing the calculation of median, interquartile ranges, and p-values.
- Conditions
- Cerebral Palsy
- Being tested
- Effects of Swiss Ball exercises, EFFECTS OF FRENKEL EXERCISES ON STATIC AND DYNAMIC BALANCE IN ATAXIC CHILDREN WITH CEREBRAL PALSY
- Keywords
- Cerebral Palsy, Ataxic, Balance, Pediatric balance scale, Swiss ball, Frenkel
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effects of Swiss Ball exercisesOther
Effects of Swiss ball exercises along with stretching as baseline treatment.
- Stretching of hamstrings, calf, and quads for 10 seconds hold 5 times.
- Swiss ball exercises. a.Sitting on the Swiss ball with the trunk straight, arms by the sides, and eyes opened progressed towards eyes closed for 10 seconds, then rest. b.Sitting on the Swiss ball with trunk straight and arm by the sides. The therapist would assist the patient to engage the patient in shifting the body's weight to one side and the other side sideways as well as anterior and posterior and up and down alternatively. Start with 10 repetitions. c. Standing with gym ball in front. The therapist would stand behind the patient to provide support and ask the patient to lean forward on the gym ball with both hands via outstretched arms. Start with 10 repetitions d. One leg weight bearing on a gym ball with the therapist behind the patient, gripping the patient's pelvis to provide support. Start with 10 repetitions
EFFECTS OF FRENKEL EXERCISES ON STATIC AND DYNAMIC BALANCE IN ATAXIC CHILDREN WITH CEREBRAL PALSYOther
Frenkel Exercises along with stretching as baseline treatment. The second intervention group would participate in Frenkel Exercises along with stretching as baseline treatment. The exercises would be performed 3 times per week for four weeks.
- Stretching of hamstrings, calf, and quads for 10 seconds hold 5 times. (11)
- Calf stretching. b. Hamstring stretches. c. Quads stretching
- Frenkel\'s lower limb exercises are the exercises listed below. The time of each session was set to be 10 minutes in the first week and then raised by 5 minutes every week. The patients were given 5 minutes to relax after 10 minutes of practice. (12)
- Supine lying
- While sitting
- Stride standing
| Study group | Role | What they receive |
|---|---|---|
| Group A:The first intervention group would participate in Swiss ball exercises along with stretching | Experimental | Group A: The first intervention group would participate in Swiss ball exercises along with stretching as baseline treatment. The exercises would be performed 3 times per week for four weeks. (12)
1. Stretching of hamstrings, calf, and quads for 10 seconds hold 5 times. (11)
1. Calf stretching
2. Hamstring stretches
3. Quad stretchings
2. 2. Swiss ball exercises
1. Sitting on the Swiss ball with the trunk straight, arms by the sides, and eyes opened progressed towards eyes closed for 10 seconds, then rest
2. Sitting on the Swiss ball with trunk straight and arm by the sides.
3. Standing with gym ball in front.
4. One leg weight bearing on a gym ball with the therapist behind the patient, gripping the patient's pelvis to provide support Receives: Other: Effects of Swiss Ball exercises |
| Group B: The second intervention group would participate in Frenkel Exercises along with stretching. | Experimental | 1. Stretching of hamstrings, calf, and quads for 10 seconds hold 5 times. (11)
1. Calf stretching
2. Hamstring stretches
3. Quads stretching
2. Frenkel's lower limb exercises are the exercises listed below. The time of each session was set to be 10 minutes in the first week and then raised by 5 minutes every week. The patients were given 5 minutes to relax after 10 minutes of practice.
a. Supine lying: i. with the head lifted; Hip abduction and adduction ii. with the head lifted, and one hip and knee extended iii. with the head lifted; and extending one leg to position the heel on the designated spot b. While sitting: i. stretch one leg to the side, bringing the heel to a spot where a mark has been made on the floor.
ii. Stride sitting; Stand up from a seated position, then return to a seated position.
c. Stride standing: i. weight transfer from foot to foot. ii. stepping sideways with feet on floor markings. iii. turn around. iv. walking and turning to avoid obstacles. Receives: Other: EFFECTS OF FRENKEL EXERCISES ON STATIC AND DYNAMIC BALANCE IN ATAXIC CHILDREN WITH CEREBRAL PALSY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric balance scale(PBS)
- Pediatric balance scale (PBS): It is a modified version of the Berg Balance Scale that is used to assess functional (static and dynamic) balance skills before and after exercises in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points. The PBS has a test-retest reliability of ICC=0.998 and a good interrater reliability of ICC=0.997.
Measured: 15 to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start24 Sep 2024
- Primary completion24 Nov 2024 (estimated)
- Study completion10 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Model description
- It will be randomized controlled trial in which non probability convenient sampling will be used two groups of ages 5-8 age will be formed in which participants will be randomly divided group A will be receive effects of swiss ball exercises and group B will receive Frenkel exercises on both dynamic and static balance.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rana Ali Raza Shoukat, MS*, Principal investigator, Riphah International Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673797
- Sponsor's protocol ID
- REC/RCR/AHS/24/Ali Raza
- Status last verified
- Nov 2024
- First submitted
- 3 Nov 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pouliot-Laforte A, Parent A, Hamdy R, Marois P, Lemay M, Ballaz L. Relationship between lower limb strength and walking capacities in children with spastic bilateral cerebral palsy. Disabil Rehabil. 2022 May;44(10):1916-1922. doi: 10.1080/09638288.2020.1813819. Epub 2020 Sep 9.
PubMed 32905745Elshafey MA, Abdrabo MS, Elnaggar RK. Effects of a core stability exercise program on balance and coordination in children with cerebellar ataxic cerebral palsy. J Musculoskelet Neuronal Interact. 2022 Jun 1;22(2):172-178.
PubMed 35642697
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Swiss Ball vs Frenkle Exercises on Static and Dynamic Balance in Ataxic Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06673797
- Acronym / sponsor ID
- REC/RCR/AHS/24/Ali Raza
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Ataxic, Balance, Pediatric balance scale, Swiss ball, Frenkel
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 24 Nov 2024 (estimated)
- Study completion
- 10 Dec 2024 (estimated)
- First posted
- 5 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.
Several studies have highlighted the significant impact of cerebral palsy, a prevailing neurological and musculoskeletal developmental disorder among childhood disabilities worldwide. Within the spectrum of cerebral palsy, ataxic CP stands as the least prevalent type, accounting for 5 to 10% of all cases. Individuals diagnosed with ataxic CP encounter difficulties in fine motor skills, precision, and coordination, and exhibit an unsteady gait, some of which are linked to compromised postural control and inadequate core stability. These issues culminate in functional limitations, heightening the risk of falls, and further contributing to the overall disability experienced by the patients. Consequently, there exists a need to prioritize research and develop targeted treatment protocols specifically for ataxic CP. It is crucial to emphasize the enhancement of postural control and coordination, with particular emphasis on improving static and dynamic balance during rehabilitation. Implementing Swiss ball exercises and Frenkel exercises in the rehabilitation protocol for children with ataxic cerebral palsy can significantly diversify treatment strategies. These exercises play a pivotal role in supporting these children to either sustain or regain their ability to function independently, reduce the risk of falls, and notably improve their overall well-being.
Detailed description
A four-week randomized clinical trial will involve 18 participants, divided randomly into two intervention groups, with nine participants in each group. Group A (intervention group 1) will participate in Swiss ball exercises combined with stretching, while Group B (intervention group 2) will partake in Frenkel exercises along with stretching. The sampling method employed will be a non-probability technique. The Pediatric Balance Scale (PBS) will serve as the primary tool for outcome measurement. Randomization will be conducted using computer-generated software. The study design will be single-blinded, ensuring the assessor remains unaware of the groups\' assignments. Initial data collection (pretest) will occur at week 0, followed by post-test data collection at week 4. For intergroup analysis, if the data follows a normal distribution, the parametric Independent t-test will be utilized, enabling the calculation of mean, standard deviation, and p-values. Alternatively, if the data does not display a normal distribution, the non-parametric Mann-Whitney test will be employed, allowing the calculation of median, interquartile ranges, and p-values.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It will be randomized controlled trial in which non probability convenient sampling will be used two groups of ages 5-8 age will be formed in which participants will be randomly divided group A will be receive effects of swiss ball exercises and group B will receive Frenkel exercises on both dynamic and static balance.
| Arm | Type | Receives |
|---|---|---|
| Group A:The first intervention group would participate in Swiss ball exercises along with stretching | Experimental | Other: Effects of Swiss Ball exercisesGroup A: The first intervention group would participate in Swiss ball exercises along with stretching as baseline treatment. The exercises would be performed 3 times per week for four weeks. (12) 1. Stretching of hamstrings, calf, and quads for 10 seconds hold 5 times. (11) 1. Calf stretching 2. Hamstring stretches 3. Quad stretchings 2. 2. Swiss ball exercises 1. Sitting on the Swiss ball with the trunk straight, arms by the sides, and eyes opened progressed towards eyes closed for 10 seconds, then rest 2. Sitting on the Swiss ball with trunk straight and arm by the sides. 3. Standing with gym ball in front. 4. One leg weight bearing on a gym ball with the therapist behind the patient, gripping the patient's pelvis to provide support |
| Group B: The second intervention group would participate in Frenkel Exercises along with stretching. | Experimental | Other: EFFECTS OF FRENKEL EXERCISES ON STATIC AND DYNAMIC BALANCE IN ATAXIC CHILDREN WITH CEREBRAL PALSY1. Stretching of hamstrings, calf, and quads for 10 seconds hold 5 times. (11) 1. Calf stretching 2. Hamstring stretches 3. Quads stretching 2. Frenkel's lower limb exercises are the exercises listed below. The time of each session was set to be 10 minutes in the first week and then raised by 5 minutes every week. The patients were given 5 minutes to relax after 10 minutes of practice. a. Supine lying: i. with the head lifted; Hip abduction and adduction ii. with the head lifted, and one hip and knee extended iii. with the head lifted; and extending one leg to position the heel on the designated spot b. While sitting: i. stretch one leg to the side, bringing the heel to a spot where a mark has been made on the floor. ii. Stride sitting; Stand up from a seated position, then return to a seated position. c. Stride standing: i. weight transfer from foot to foot. ii. stepping sideways with feet on floor markings. iii. turn around. iv. walking and turning to avoid obstacles. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients with having diagnosis of ataxic cerebral palsy
- Age between 5 to 8 years.
- GMFC level 2.
- Both the genders were included
Key exclusion criteria (4 listed)
- Visual Impairments and hearing loss
- Mental retardation
- Fixed contractures or deformities of the spine or extremities
- Meningitis
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 |
|---|---|---|
| Effects of Swiss Ball exercisesEffects of Swiss ball exercises along with stretching as baseline treatment. 1. Stretching of hamstrings, calf, and quads for 10 seconds hold 5 times. 2. Swiss ball exercises. a.Sitting on the Swiss ball with the trunk straight, arms by the sides, and eyes opened progressed towards eyes closed for 10 seconds, then rest. b.Sitting on the Swiss ball with trunk straight and arm by the sides. The therapist would assist the patient to engage the patient in shifting the body's weight to one side and the other side sideways as well as anterior and posterior and up and down alternatively. Start with 10 repetitions. c. Standing with gym ball in front. The therapist would stand behind the patient to provide support and ask the patient to lean forward on the gym ball with both hands via outstretched arms. Start with 10 repetitions d. One leg weight bearing on a gym ball with the therapist behind the patient, gripping the patient's pelvis to provide support. Start with 10 repetitions | Other | Group A:The first intervention group would participate in Swiss ball exercises along with stretching |
| EFFECTS OF FRENKEL EXERCISES ON STATIC AND DYNAMIC BALANCE IN ATAXIC CHILDREN WITH CEREBRAL PALSYFrenkel Exercises along with stretching as baseline treatment. The second intervention group would participate in Frenkel Exercises along with stretching as baseline treatment. The exercises would be performed 3 times per week for four weeks. 1. Stretching of hamstrings, calf, and quads for 10 seconds hold 5 times. (11) a. Calf stretching. b. Hamstring stretches. c. Quads stretching 2. Frenkel\'s lower limb exercises are the exercises listed below. The time of each session was set to be 10 minutes in the first week and then raised by 5 minutes every week. The patients were given 5 minutes to relax after 10 minutes of practice. (12) 1. Supine lying 2. While sitting 3. Stride standing | Other | Group B: The second intervention group would participate in Frenkel Exercises along with stretching. |
Primary outcome
Pediatric balance scale(PBS)
Time frame: 15 to 20 minutes
• Pediatric balance scale (PBS): It is a modified version of the Berg Balance Scale that is used to assess functional (static and dynamic) balance skills before and after exercises in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points. The PBS has a test-retest reliability of ICC=0.998 and a good interrater reliability of ICC=0.997.
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 5 Nov 2024.
- Background: PubMed 32905745Pouliot-Laforte A, Parent A, Hamdy R, Marois P, Lemay M, Ballaz L. Relationship between lower limb strength and walking capacities in children with spastic bilateral cerebral palsy. Disabil Rehabil. 2022 May;44(10):1916-1922. doi: 10.1080/09638288.2020.1813819. Epub 2020 Sep 9.
- Background: PubMed 35642697Elshafey MA, Abdrabo MS, Elnaggar RK. Effects of a core stability exercise program on balance and coordination in children with cerebellar ataxic cerebral palsy. J Musculoskelet Neuronal Interact. 2022 Jun 1;22(2):172-178.
- 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.
Rana Ali Raza Shoukat, MS* principal investigator
Riphah International Univerisity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effects of Swiss Ball exercises and EFFECTS OF FRENKEL EXERCISES ON STATIC AND DYNAMIC BALANCE IN ATAXIC CHILDREN WITH CEREBRAL PALSY in people with 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 4 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: looking for participants now, as of the sponsor's last update on 5 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?
Contact Imran Amjad, PhD (9233224390125, Imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric balance scale(PBS) (time frame: 15 to 20 minutes). 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 NCT06673797, which also lists 2 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 5 Nov 2024; AzTrials last refreshed its copy on 26 Oct 2026.