Cerebral PalsyNCT06190418
Loaded Vs Unloaded Sit to Stand Strengthening Exercises in Children With Cerebral Palsy
A study testing Loaded sit to stand strengthening exercise and Unloaded sit to stand strengthening exercise in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cerebral palsy(CP) is non-progressive disorder, undergo mishap to the developing brain and it affect a person's ability to move and maintain balance and posture. Old name of CP is "Little's disease". Cerebral means having to do with the brain. Palsy means weakness or problems with using the muscles. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Loaded sit to stand strengthening exercise and Unloaded sit to stand strengthening exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 30 Mar 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Spastic diplegic cerebral palsy
- Age between 6 to 12 years
- Children with GMFCS level I and II
- Able to stand up from chair independently and maintain standing for more than 5 second without falling.
- Had not received any strengthening exercise program in past 3 months
- Parental commitment to allow participation without altering current activity
Who cannot join
- Participants with epileptic history and lower limb contractures are excluded
- Those who are unable to follow verbal command
- Have orthopedic intervention such as selective dorsal rhizotomy or botolinum toxin injection to lower extremities within past 6 months
- Orthopedic condition or medical problems that prevent children from participating in exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Loaded and Unloaded Sit to Stand Strengthening Exercises on Functional Strength and Energy Expenditure in Children With Cerebral Palsy
Cerebral palsy(CP) is non-progressive disorder, undergo mishap to the developing brain and it affect a person's ability to move and maintain balance and posture. Old name of CP is "Little's disease". Cerebral means having to do with the brain. Palsy means weakness or problems with using the muscles. In Spastic diplegic, muscle stiffness is mainly in the legs, with the arms less affected or not affected at all. The most common cause of spastic diplegia is Periventricular leukomalacia, more commonly known as neonatal asphyxia or infant hypoxia-a sudden in-womb shortage of oxygen-delivery through the umbilical cord. Strength exercise is any activity that makes your muscles work harder than usual.
The significance of this study is that it will define whether loaded or unloaded sit to stand strengthening exercises have good effect on muscle strength and energy expenditure in diaplegic CP. This will be a randomized clinical trial, data will be collected from District Head Quarter DHQ hafizabad. Study will be conducted on 32 patients. Inclusion criteria of this study is spastic diplegic CP children with age between 6 to 12 years, with GMFCS level 1 and 2 and those who are able to stand up from chair independently and maintain standing for more than 5 seconds without falling will be included.Diplegic CP children who had not received any strengthening exercise program in past 3 months and those less than 20 degrees limitation in passive range of motion in hip flexion will be included. Those diplegic spastic CP who have orthopedic intervention such as selective dorsal rhizotomy or botolinum toxin injection to lower extremities within past six months and orthopedic conditions or medical problems that prevented children from participating in exercises will be excluded. Group A will be provided with loaded sit to stand strengthening exercises. 1 repetition maximum(1-RM) will be used as loaded sit to stand test. Group B will be provided with unloaded sit to stand strengthening exercises. Pre and post session lower limb functional strength will be measured by performing functional strength tests while lower limb muscular strength will be measured via modified sphygmomanometer and physiological cost index will be measured to rule out energy expenditure.
- Conditions
- Cerebral Palsy
- Being tested
- Loaded sit to stand strengthening exercise, Unloaded sit to stand strengthening exercise
- Keywords
- Cerebral Palsy,, Energy Expenditure,, Muscle Strength
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loaded sit to stand strengthening exerciseOther
This Group will be given with the wieghted vest equal to that of 1RM for each child and Sit-to-Stand Strengthening Excerise will be given 3 times per week for 6 weeks
Unloaded sit to stand strengthening exerciseOther
This Group will be given with the Sit-to-Stand Strengthening Excerise without any external load for 3 times per week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Loaded sit to stand strengthening exercise group | Active comparator | This group will be provided with loaded sit to stand strengthening exercises in spastic diplegic children.1 repetition maximum of the load will be provided. Exercise will be conducted 3 times a week for 6 weeks, pre and post session functional strength of lower limb will be measured by performing functional strength tests and physiological cost index will be measured to calculate energy expenditure. Receives: Other: Loaded sit to stand strengthening exercise |
| Unloaded sit to stand strengthening exercise group | Active comparator | This Group will be provided with unloaded sit to stand exercises in diplegic spastic CP, 3 times a week for 6 weeks. Pre and post session functional strength of lower limb muscles will be measured by performing functional strength tests and physiological cost index will be measured to determine energy expenditure. Receives: Other: Unloaded sit to stand strengthening exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength
Muscle strength will be assessed by Bag method of Modified Sphygmomanometer
Measured: Baseline and 6th week
Energy Expenditure
To find out energy expenditure, physiological cost index (PCI) will be measured. PCI will be calculated by using the following formula: PCI (beats/meter)= Final heart rate -Resting Heart Rate /speed of walking
Measured: Baseline and 6th week
Secondary outcomes (2)
Functional Strenght -Lateral Step-up Test (on a 20 cm bench)
To assess functional strength, following tests will be used:
The Lateral Step-up Test (on a 20 cm bench)
Measured: Baseline and 6th week
Functional Strenght -Sit-to-Stand (from 90 flexion of the knee and hip to standing position)
To assess functional strength, following tests will be used:
The Sit-to-Stand (from 90 flexion of the knee and hip to standing position) Attain stand through half kneel, without using arms.
Measured: Baseline and 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Nov 2023
- Primary completion15 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wasifa Rauf, MSPT(Peads), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190418
- Sponsor's protocol ID
- REC/RCR & AHS/23/0729
- Status last verified
- Jul 2024
- First submitted
- 9 Nov 2023
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kusumoto Y, Nitta O, Takaki K. Impact of loaded sit-to-stand exercises at different speeds on the physiological cost of walking in children with spastic diplegia: A single-blind randomized clinical trial. Res Dev Disabil. 2016 Oct;57:85-91. doi: 10.1016/j.ridd.2016.06.006. Epub 2016 Jul 7.
PubMed 27394691Lee J, Suk MH, Yoo S, Kwon JY. Physical Activity Energy Expenditure Predicts Quality of Life in Ambulatory School-Age Children with Cerebral Palsy. J Clin Med. 2022 Jun 11;11(12):3362. doi: 10.3390/jcm11123362.
PubMed 35743433Liao HF, Liu YC, Liu WY, Lin YT. Effectiveness of loaded sit-to-stand resistance exercise for children with mild spastic diplegia: a randomized clinical trial. Arch Phys Med Rehabil. 2007 Jan;88(1):25-31. doi: 10.1016/j.apmr.2006.10.006.
PubMed 17207671
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Loaded and Unloaded Sit to Stand Strengthening Exercises on Functional Strength and Energy Expenditure in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06190418
- Acronym / sponsor ID
- REC/RCR & AHS/23/0729
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy,, Energy Expenditure,, Muscle Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 5 Jan 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.
Cerebral palsy(CP) is non-progressive disorder, undergo mishap to the developing brain and it affect a person's ability to move and maintain balance and posture. Old name of CP is "Little's disease". Cerebral means having to do with the brain. Palsy means weakness or problems with using the muscles. In Spastic diplegic, muscle stiffness is mainly in the legs, with the arms less affected or not affected at all. The most common cause of spastic diplegia is Periventricular leukomalacia, more commonly known as neonatal asphyxia or infant hypoxia-a sudden in-womb shortage of oxygen-delivery through the umbilical cord. Strength exercise is any activity that makes your muscles work harder than usual.
The significance of this study is that it will define whether loaded or unloaded sit to stand strengthening exercises have good effect on muscle strength and energy expenditure in diaplegic CP. This will be a randomized clinical trial, data will be collected from District Head Quarter DHQ hafizabad. Study will be conducted on 32 patients. Inclusion criteria of this study is spastic diplegic CP children with age between 6 to 12 years, with GMFCS level 1 and 2 and those who are able to stand up from chair independently and maintain standing for more than 5 seconds without falling will be included.Diplegic CP children who had not received any strengthening exercise program in past 3 months and those less than 20 degrees limitation in passive range of motion in hip flexion will be included. Those diplegic spastic CP who have orthopedic intervention such as selective dorsal rhizotomy or botolinum toxin injection to lower extremities within past six months and orthopedic conditions or medical problems that prevented children from participating in exercises will be excluded. Group A will be provided with loaded sit to stand strengthening exercises. 1 repetition maximum(1-RM) will be used as loaded sit to stand test. Group B will be provided with unloaded sit to stand strengthening exercises. Pre and post session lower limb functional strength will be measured by performing functional strength tests while lower limb muscular strength will be measured via modified sphygmomanometer and physiological cost index will be measured to rule out energy expenditure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loaded sit to stand strengthening exercise group | Active comparator | Other: Loaded sit to stand strengthening exerciseThis group will be provided with loaded sit to stand strengthening exercises in spastic diplegic children.1 repetition maximum of the load will be provided. Exercise will be conducted 3 times a week for 6 weeks, pre and post session functional strength of lower limb will be measured by performing functional strength tests and physiological cost index will be measured to calculate energy expenditure. |
| Unloaded sit to stand strengthening exercise group | Active comparator | Other: Unloaded sit to stand strengthening exerciseThis Group will be provided with unloaded sit to stand exercises in diplegic spastic CP, 3 times a week for 6 weeks. Pre and post session functional strength of lower limb muscles will be measured by performing functional strength tests and physiological cost index will be measured to determine energy expenditure. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Spastic diplegic cerebral palsy
- Age between 6 to 12 years
- Children with GMFCS level I and II
- Able to stand up from chair independently and maintain standing for more than 5 second without falling.
- Had not received any strengthening exercise program in past 3 months
Key exclusion criteria (4 listed)
- Participants with epileptic history and lower limb contractures are excluded
- Those who are unable to follow verbal command
- Have orthopedic intervention such as selective dorsal rhizotomy or botolinum toxin injection to lower extremities within past 6 months
- Orthopedic condition or medical problems that prevent children from participating in exercise
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 |
|---|---|---|
| Loaded sit to stand strengthening exerciseThis Group will be given with the wieghted vest equal to that of 1RM for each child and Sit-to-Stand Strengthening Excerise will be given 3 times per week for 6 weeks | Other | Loaded sit to stand strengthening exercise group |
| Unloaded sit to stand strengthening exerciseThis Group will be given with the Sit-to-Stand Strengthening Excerise without any external load for 3 times per week for 6 weeks | Other | Unloaded sit to stand strengthening exercise group |
Primary outcome
Muscle Strength
Time frame: Baseline and 6th week
Muscle strength will be assessed by Bag method of Modified Sphygmomanometer
Energy Expenditure
Time frame: Baseline and 6th week
To find out energy expenditure, physiological cost index (PCI) will be measured. PCI will be calculated by using the following formula: PCI (beats/meter)= Final heart rate -Resting Heart Rate /speed of walking
2 secondary outcomes
Functional Strenght -Lateral Step-up Test (on a 20 cm bench)
Time frame: Baseline and 6th week
Functional Strenght -Sit-to-Stand (from 90 flexion of the knee and hip to standing position)
Time frame: Baseline and 6th 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 10 Jul 2024.
- Background: PubMed 27394691Kusumoto Y, Nitta O, Takaki K. Impact of loaded sit-to-stand exercises at different speeds on the physiological cost of walking in children with spastic diplegia: A single-blind randomized clinical trial. Res Dev Disabil. 2016 Oct;57:85-91. doi: 10.1016/j.ridd.2016.06.006. Epub 2016 Jul 7.
- Background: PubMed 35743433Lee J, Suk MH, Yoo S, Kwon JY. Physical Activity Energy Expenditure Predicts Quality of Life in Ambulatory School-Age Children with Cerebral Palsy. J Clin Med. 2022 Jun 11;11(12):3362. doi: 10.3390/jcm11123362.
- Background: PubMed 17207671Liao HF, Liu YC, Liu WY, Lin YT. Effectiveness of loaded sit-to-stand resistance exercise for children with mild spastic diplegia: a randomized clinical trial. Arch Phys Med Rehabil. 2007 Jan;88(1):25-31. doi: 10.1016/j.apmr.2006.10.006.
- 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.
Wasifa Rauf, MSPT(Peads) 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 Loaded sit to stand strengthening exercise and Unloaded sit to stand strengthening exercise 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 6 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 10 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?
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?
Muscle Strength (time frame: Baseline and 6th week). 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 NCT06190418, which also lists 3 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 10 Jul 2024.