Cerebral PalsyNCT06529328
Trunk Stabilization vs. Core Stability Exercises: Impact on Balance and Walking Ability in Cerebral Palsy.
A study testing core stability in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Brain lesions cause cerebral palsy, a chronic condition that affects movement, posture, and balance. Its causes range in age from pregnancy to postpartum, and they can impact the neurological, musculoskeletal, and sensory systems. This causes problems with balance, movement, and posture. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- core stability
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2024to 20 Dec 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 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ● Gender: both girls and boys;
- ● Age: 2-7 years.
- ● Diagnosis: spastic CP.
- ● According to the modified Ashworth scale, the affected lower extremity's degree of spasticity falls between grades 1 and 2.
- PBS > 32.
Who cannot join
- ● Got a timing injection with botulinum toxin.
- ● Epilepsy | Seizures.
- ● Lower limb surgery performed throughout the research period.
- Any deformity or orthopedic condition that affects balance. Deficits in vision and hearing with a MACS score higher than three will not be considered.
- ● PBS rating less than 32.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah International university
Lahore, Punjab Province, 54000
Imran Amjad, PhD, 03224390125, imran.amjad@riphah.edu.pk
Muhammad Asif Javed, MS, 03224209422, a.javed@riphah.edu.pk
About this study
Official title: Effect of Core Stability Exercise Versus Trunk Stabilization Exercise on Balance and Walking Abilities in Cerebral Palsy.
Brain lesions cause cerebral palsy, a chronic condition that affects movement, posture, and balance. Its causes range in age from pregnancy to postpartum, and they can impact the neurological, musculoskeletal, and sensory systems. This causes problems with balance, movement, and posture. It is essential to intervene early for improved life quality. Maintaining a constant center of gravity within your support base is referred to as balance. Walking is putting one foot on the ground at all times and lifting and lowering each foot in turn. The stability of the trunk and core is necessary for muscle coordination and deliberate motions. A study compares the efficiency of trunk stabilization and core exercises to enhance balance and evaluates mobility changes, such as altered muscle strength, endurance, and gait, as a result of two treatment approaches.
Read the detailed description
Experiment group 1: During the course of the study, the experimental group will engage in three sessions of thirty to forty-five minutes each, dedicated to performing core stability exercises. The exercises will target the challenging muscles of the trunk and abdomen.
Weeks one and two:
- Lying supine and contracting abdominal muscles three sets of twenty repetitions each.
- While lying prone, contract your abdominal muscles three sets of twenty repetitions each.
- Squatting and contracting abdominal muscles for three sets of twenty repetitions each.
Week three: Contracting abdominal muscles while lying supine with one leg extended and the other pressed against the abdomen and bent at the knee Fourth week: ● Pulling the limbs upward while keeping the arms and legs close together and contracting the abdominal muscles (3 sets and 20 reps in each set).
- One leg is raised and pulled outward and backward while performing a squat (3 sets per leg, 20 reps per set).
- Rotate your hips while gripping weights in each hand. Perform three sets of 20 repetitions for each body part.
Fifth week: (3 sets of 10 seconds) holding the abdomen in while sitting on a Swiss ball.
● Squatting with the Swiss ball resting on your shoulder, three sets of fifteen repetitions each.
Elevating both the arms and legs in the prone position at the same time (3 sets and 10 repetitions).
Week six: ● Bending 45 degrees to the left or right. ● Bridging with one leg raised and shoulders and hands on the floor (three sets with a 15-second break in between each set).
● Contracting abdominal muscles on the Swiss ball while lying supine (3 sets, 20 reps per set).
During the seventh week, perform three sets of fifteen reps each of lying supine on a Swiss ball and rotating your trunk to the sides.
- Performing the aforementioned exercise while gripping weights for three sets of fifteen repetitions each.
- Side-lying bridge with leg raises (6 reps on each side of the body, followed by a 10-second rest).
Week eight: ● Lying flat on the Swiss ball with the abdomen tucked in and raising one leg (three sets of twenty repetitions each).
● While squatting, raise the opposing arm and leg three times, completing 20 repetitions per set. - Bridge for three sets, pausing for 15 seconds in between each set, with feet on the Swiss ball and one leg raised.
Experiment group 2: For three days per week on non-consecutive days, the subjects underwent a 30-minute trunk stabilization exercise program in addition to 25 minutes of conventional therapy.
All tense muscles, including the hamstrings and calf muscles in the lower limb, can benefit from passive stretching exercises. First, it is done five times, then you work your way up to ten repetitions, stretch five times, and finally take five minutes to relax. Extensor muscle strengthening exercises for the back, hips, and knees (for 10 minutes).
Next, carry out the exercise for trunk stabilization. The supine exercise involves the child pulling in their abdominals towards their back while lying supine and flexing their knees. Alternatively, the child can place their feet on the dome and lift their legs.
- Conditions
- Cerebral Palsy
- Being tested
- core stability
- Keywords
- Cerebral palsy,, Balance,, Core Stability,, Trunk Stabilization.
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core stabilityOther
Also called trunk stability
In this study the experimental group will perform core stability exercises 3 times per week for an 8-week period and each session of 30 to 45 minutes, the core stability exercises will work on abdominals and trunk muscles with challenges.Subjects received 25 min conventional therapy in addition to 30 30-minute trunk stabilization exercise program conducted for 3 days\week on non-consecutive days.
Passive stretching exercises are applied to all tight muscles, including the hamstrings and calf muscles in the lower limb. It is performed five times initially, building up to ten repetitions, stretching for 5 times, and then allowing relaxation for 5time. Strengthening exercises for back, hip, and knee extensor muscles (for 10 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | For eight weeks, the experimental group in this study will engage in three sessions of thirty to forty-five minutes each, dedicated to core stability exercises that will challenge the muscles of the trunk and abdomen. Receives: Other: core stability |
| Group B | Experimental | In addition to receiving 25 minutes of conventional therapy, the subjects participated in a 30-minute trunk stabilization exercise program three days a week on non-consecutive days.
All tense muscles, including the hamstrings and calf muscles in the lower limb, can benefit from passive stretching exercises. First, it is done five times, then you work your way up to ten repetitions, stretch five times, and finally take five minutes to relax. Extensor muscle strengthening exercises for the back, hips, and knees (for 10 minutes). Receives: Other: core stability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Reach Test (Pediatric Functional Reach Test)
Functional Reach will be measured
Measured: 8weeks
Manual Ability Classification System
ability of children with cerebral palsy to handle objects with the help of their hands.
Measured: 8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Jun 2024
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 control trail in which nonprobability convenient sampling will be used. two groups of 2 to 7 years age will be formed in which participants will be randomly divided. Group A: will receive , CP children will receive core stability exercises. Group B: Experiment group B, CP children will receive trunk stability exercise.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saba Munir, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529328
- Sponsor's protocol ID
- REC/RCR&AHS/23/0794
- Status last verified
- Jul 2024
- First submitted
- 11 Jun 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vitrikas K, Dalton H, Breish D. Cerebral Palsy: An Overview. Am Fam Physician. 2020 Feb 15;101(4):213-220.
PubMed 32053326
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Core Stability Exercise Versus Trunk Stabilization Exercise on Balance and Walking Abilities in Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT06529328
- Acronym / sponsor ID
- REC/RCR&AHS/23/0794
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy,, Balance,, Core Stability,, Trunk Stabilization.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 31 Jul 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.
Brain lesions cause cerebral palsy, a chronic condition that affects movement, posture, and balance. Its causes range in age from pregnancy to postpartum, and they can impact the neurological, musculoskeletal, and sensory systems. This causes problems with balance, movement, and posture. It is essential to intervene early for improved life quality. Maintaining a constant center of gravity within your support base is referred to as balance. Walking is putting one foot on the ground at all times and lifting and lowering each foot in turn. The stability of the trunk and core is necessary for muscle coordination and deliberate motions. A study compares the efficiency of trunk stabilization and core exercises to enhance balance and evaluates mobility changes, such as altered muscle strength, endurance, and gait, as a result of two treatment approaches.
Detailed description
Experiment group 1: During the course of the study, the experimental group will engage in three sessions of thirty to forty-five minutes each, dedicated to performing core stability exercises. The exercises will target the challenging muscles of the trunk and abdomen.
Weeks one and two:
- Lying supine and contracting abdominal muscles three sets of twenty repetitions each.
- While lying prone, contract your abdominal muscles three sets of twenty repetitions each.
- Squatting and contracting abdominal muscles for three sets of twenty repetitions each.
Week three: Contracting abdominal muscles while lying supine with one leg extended and the other pressed against the abdomen and bent at the knee Fourth week: ● Pulling the limbs upward while keeping the arms and legs close together and contracting the abdominal muscles (3 sets and 20 reps in each set).
- One leg is raised and pulled outward and backward while performing a squat (3 sets per leg, 20 reps per set).
- Rotate your hips while gripping weights in each hand. Perform three sets of 20 repetitions for each body part.
Fifth week: (3 sets of 10 seconds) holding the abdomen in while sitting on a Swiss ball.
● Squatting with the Swiss ball resting on your shoulder, three sets of fifteen repetitions each.
Elevating both the arms and legs in the prone position at the same time (3 sets and 10 repetitions).
Week six: ● Bending 45 degrees to the left or right. ● Bridging with one leg raised and shoulders and hands on the floor (three sets with a 15-second break in between each set).
● Contracting abdominal muscles on the Swiss ball while lying supine (3 sets, 20 reps per set).
During the seventh week, perform three sets of fifteen reps each of lying supine on a Swiss ball and rotating your trunk to the sides.
- Performing the aforementioned exercise while gripping weights for three sets of fifteen repetitions each.
- Side-lying bridge with leg raises (6 reps on each side of the body, followed by a 10-second rest).
Week eight: ● Lying flat on the Swiss ball with the abdomen tucked in and raising one leg (three sets of twenty repetitions each).
● While squatting, raise the opposing arm and leg three times, completing 20 repetitions per set. - Bridge for three sets, pausing for 15 seconds in between each set, with feet on the Swiss ball and one leg raised.
Experiment group 2: For three days per week on non-consecutive days, the subjects underwent a 30-minute trunk stabilization exercise program in addition to 25 minutes of conventional therapy.
All tense muscles, including the hamstrings and calf muscles in the lower limb, can benefit from passive stretching exercises. First, it is done five times, then you work your way up to ten repetitions, stretch five times, and finally take five minutes to relax. Extensor muscle strengthening exercises for the back, hips, and knees (for 10 minutes).
Next, carry out the exercise for trunk stabilization. The supine exercise involves the child pulling in their abdominals towards their back while lying supine and flexing their knees. Alternatively, the child can place their feet on the dome and lift their legs.
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 control trail in which nonprobability convenient sampling will be used. two groups of 2 to 7 years age will be formed in which participants will be randomly divided. Group A: will receive , CP children will receive core stability exercises. Group B: Experiment group B, CP children will receive trunk stability exercise.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: core stabilityFor eight weeks, the experimental group in this study will engage in three sessions of thirty to forty-five minutes each, dedicated to core stability exercises that will challenge the muscles of the trunk and abdomen. |
| Group B | Experimental | Other: core stabilityIn addition to receiving 25 minutes of conventional therapy, the subjects participated in a 30-minute trunk stabilization exercise program three days a week on non-consecutive days. All tense muscles, including the hamstrings and calf muscles in the lower limb, can benefit from passive stretching exercises. First, it is done five times, then you work your way up to ten repetitions, stretch five times, and finally take five minutes to relax. Extensor muscle strengthening exercises for the back, hips, and knees (for 10 minutes). |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- ● Gender: both girls and boys;
- ● Age: 2-7 years.
- ● Diagnosis: spastic CP.
- ● According to the modified Ashworth scale, the affected lower extremity's degree of spasticity falls between grades 1 and 2.
- PBS > 32.
Key exclusion criteria (5 listed)
- ● Got a timing injection with botulinum toxin.
- ● Epilepsy | Seizures.
- ● Lower limb surgery performed throughout the research period.
- Any deformity or orthopedic condition that affects balance. Deficits in vision and hearing with a MACS score higher than three will not be considered.
- ● PBS rating less than 32.
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 |
|---|---|---|
| core stabilityAlso: trunk stabilityIn this study the experimental group will perform core stability exercises 3 times per week for an 8-week period and each session of 30 to 45 minutes, the core stability exercises will work on abdominals and trunk muscles with challenges.Subjects received 25 min conventional therapy in addition to 30 30-minute trunk stabilization exercise program conducted for 3 days\week on non-consecutive days. Passive stretching exercises are applied to all tight muscles, including the hamstrings and calf muscles in the lower limb. It is performed five times initially, building up to ten repetitions, stretching for 5 times, and then allowing relaxation for 5time. Strengthening exercises for back, hip, and knee extensor muscles (for 10 minutes). | Other | Group A, Group B |
Primary outcome
Pediatric Reach Test (Pediatric Functional Reach Test)
Time frame: 8weeks
Functional Reach will be measured
Manual Ability Classification System
Time frame: 8weeks
ability of children with cerebral palsy to handle objects with the help of their hands.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Background: PubMed 32053326Vitrikas K, Dalton H, Breish D. Cerebral Palsy: An Overview. Am Fam Physician. 2020 Feb 15;101(4):213-220.
- 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.
Saba Munir, MS* 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 core stability 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 5 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: status not confirmed, as of the sponsor's last update on 31 Jul 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?
Results are not available in the source record.
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 Reach Test (Pediatric Functional Reach Test) (time frame: 8weeks). The study lists 2 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 NCT06529328, which also lists 1 linked publication.
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 31 Jul 2024.