Cerebral PalsyNCT05787210
Quadriceps Strength Training on Gait Parameters and Energy Expenditure in Children With Spastic Cerebral Palsy
A study testing Conventiional Physiotherapy and Quadriceps Strength Training in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The incidence of cerebral palsy is approximately 2 to 3 cases per 1000 live births around the world. In Cerebral palsy the lesion in the central nervous system frequently results in spasticity of various muscle groups. Spasticity is defined as a velocity dependent resistance to stretch. 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?
- Conventiional Physiotherapy and Quadriceps Strength Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Mar 2023to 30 Aug 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diplegic Cerebral palsy
- (GMFC) level 1 and 2
- Able to follow verbal direction for standard testing
Who cannot join
- Orthopedic and Neurosurgery in last 12 months
- Children with any associated medical condition
- Children with Botox therapy in last six months
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Al-noor Special Children School
Multan, Punjab Province, 59300
About this study
Official title: Effects of Quadriceps Strength Training on Gait Parameters and Energy Expenditure in Children With Spastic Cerebral Palsy
The incidence of cerebral palsy is approximately 2 to 3 cases per 1000 live births around the world. In Cerebral palsy the lesion in the central nervous system frequently results in spasticity of various muscle groups. Spasticity is defined as a velocity dependent resistance to stretch. Spastic Cerebral palsy is caused by damage to the pyramidal parts of the brain.
The children with spastic CP frequently experience problems with motor control, and balance which may lead to gait abnormalities. Because of motor weakness and poor voluntary motor control the children with spastic cerebral palsy develop crouch gait characterized by excessive hip and knee flexion and a slower walking speed, a shorter stride length, and more time spent in double support. This study will help in the quality of life in spastic cerebral palsy children. This will be a Randomized Controlled Trial. Approval will be gained from the Ethical committee of the Riphah international university Lahore, Pakistan prior to the commencement of study. Written informed consent will be taken from all the patients and all information and data will be confidential. Subjects will be informed that there is no risk of study and they will be free to withdraw any time during process of study. 22 Children with Spastic CP will be randomly distributed into 2 groups. The Control Group (n=10) will be administered with the baseline treatment that Includes 5 minutes of trunk control training, 5 minutes walking in the hall with And without the therapist assistance, walker or crutches, and finally 5 minutes of Breathing exercises for Relaxation 3 sessions per week for 8 weeks. The experimental group (n=10) will be administered with the strength training intervention along with baseline treatment, 3 sessions per week for 8 weeks. Gait parameters will be evaluated physically by measuring stride and step length and cadence.
5-meter stretch test for gait parameters. the energy expenditure will be calculated by measuring the physiological cost index that includes measuring the speed of walking and resulting increase in heart rate. Data will be analyzed by using SPSS version 26.0 and necessary analysis will be done after checking the normality of Data.
- Conditions
- Cerebral Palsy
- Being tested
- Conventiional Physiotherapy, Quadriceps Strength Training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventiional PhysiotherapyOther
The Control group will be administered with Conventional Physiotherapy that Includes 5 minutes of trunk control training, 5 minutes walking in the hall with And without the therapist assistance, walker or crutches, and finally 5 minutes of Breathing exercises for Relaxation
Quadriceps Strength TrainingOther
The experimental group will be administered with the same baseline treatment such as 5 minutes of trunk control training, 5 minutes walking in the hall with or without the therapist assistance, walker or crutches and 5 minutes breathing exercises for relaxation. In addition, they were given strength training protocol intervention other than the baseline treatment. This strength training protocol include progressive resistance training program in which we gave leg lift (knee flexion and extension), Hip rotations, seated marching and the quadriceps muscles would be specifically targeted.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Not described Receives: Other: Conventiional Physiotherapy |
| Strength | Experimental | Not described Receives: Other: Conventiional Physiotherapy; Other: Quadriceps Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gait parameters
5-meter stretch test for gait parameters that include: the participant to walk barefoot with their normal speed on a 5-mt stretch of plain white paper with inked foot within a fixed time and it was recorded using a stopwatch. Prior to data collection, all participants had an opportunity to practice walking, as first few steps were discarded. The gait parameters analyzed will be step length, stride length, cadence and gait speed
Measured: Baseline and 8th week
Change in ENERGY EXPENDITURE
The Physiological Cost Index was introduced by MacGregor and is used to check energy expenditure. it is calculated by estimating the speed of walking and the increase in heart rate after the child has walked a specified distance at a self-selected pace. .We calculate the physiological cost index by Formula for calculation PCI is: PCI (beats/min) = Walking heart rate
- Resting heart rate / walking speed (m/min)
Measured: Baseline and 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start9 Mar 2023
- Primary completion15 Aug 2023
- Study completion30 Aug 2023
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fareeha Kausar, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787210
- Sponsor's protocol ID
- REC/RCR & AHS/23/0704
- Status last verified
- Dec 2023
- First submitted
- 15 Mar 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valadao P, Piitulainen H, Haapala EA, Parviainen T, Avela J, Finni T. Exercise intervention protocol in children and young adults with cerebral palsy: the effects of strength, flexibility and gait training on physical performance, neuromuscular mechanisms and cardiometabolic risk factors (EXECP). BMC Sports Sci Med Rehabil. 2021 Feb 26;13(1):17. doi: 10.1186/s13102-021-00242-y.
PubMed 33637124Bhilwade1 DAH, DSSGP. Effect of Spasticity on Gait Parameters and Physiological Cost Index in Patients with Spastic Cerebral Palsy. 2020
Merino-Andres J, Garcia de Mateos-Lopez A, Damiano DL, Sanchez-Sierra A. Effect of muscle strength training in children and adolescents with spastic cerebral palsy: A systematic review and meta-analysis. Clin Rehabil. 2022 Jan;36(1):4-14. doi: 10.1177/02692155211040199. Epub 2021 Aug 18.
PubMed 34407619
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Quadriceps Strength Training on Gait Parameters and Energy Expenditure in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05787210
- Acronym / sponsor ID
- REC/RCR & AHS/23/0704
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 28 Mar 2023 (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 incidence of cerebral palsy is approximately 2 to 3 cases per 1000 live births around the world. In Cerebral palsy the lesion in the central nervous system frequently results in spasticity of various muscle groups. Spasticity is defined as a velocity dependent resistance to stretch. Spastic Cerebral palsy is caused by damage to the pyramidal parts of the brain.
The children with spastic CP frequently experience problems with motor control, and balance which may lead to gait abnormalities. Because of motor weakness and poor voluntary motor control the children with spastic cerebral palsy develop crouch gait characterized by excessive hip and knee flexion and a slower walking speed, a shorter stride length, and more time spent in double support. This study will help in the quality of life in spastic cerebral palsy children. This will be a Randomized Controlled Trial. Approval will be gained from the Ethical committee of the Riphah international university Lahore, Pakistan prior to the commencement of study. Written informed consent will be taken from all the patients and all information and data will be confidential. Subjects will be informed that there is no risk of study and they will be free to withdraw any time during process of study. 22 Children with Spastic CP will be randomly distributed into 2 groups. The Control Group (n=10) will be administered with the baseline treatment that Includes 5 minutes of trunk control training, 5 minutes walking in the hall with And without the therapist assistance, walker or crutches, and finally 5 minutes of Breathing exercises for Relaxation 3 sessions per week for 8 weeks. The experimental group (n=10) will be administered with the strength training intervention along with baseline treatment, 3 sessions per week for 8 weeks. Gait parameters will be evaluated physically by measuring stride and step length and cadence.
5-meter stretch test for gait parameters. the energy expenditure will be calculated by measuring the physiological cost index that includes measuring the speed of walking and resulting increase in heart rate. Data will be analyzed by using SPSS version 26.0 and necessary analysis will be done after checking the normality of Data.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Conventiional Physiotherapy |
| Strength | Experimental | Other: Conventiional Physiotherapy, Other: Quadriceps Strength Training |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diplegic Cerebral palsy
- (GMFC) level 1 and 2
- Able to follow verbal direction for standard testing
Key exclusion criteria (3 listed)
- Orthopedic and Neurosurgery in last 12 months
- Children with any associated medical condition
- Children with Botox therapy in last six months
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 |
|---|---|---|
| Conventiional PhysiotherapyThe Control group will be administered with Conventional Physiotherapy that Includes 5 minutes of trunk control training, 5 minutes walking in the hall with And without the therapist assistance, walker or crutches, and finally 5 minutes of Breathing exercises for Relaxation | Other | Control group, Strength |
| Quadriceps Strength TrainingThe experimental group will be administered with the same baseline treatment such as 5 minutes of trunk control training, 5 minutes walking in the hall with or without the therapist assistance, walker or crutches and 5 minutes breathing exercises for relaxation. In addition, they were given strength training protocol intervention other than the baseline treatment. This strength training protocol include progressive resistance training program in which we gave leg lift (knee flexion and extension), Hip rotations, seated marching and the quadriceps muscles would be specifically targeted. | Other | Strength |
Primary outcome
Change in Gait parameters
Time frame: Baseline and 8th week
5-meter stretch test for gait parameters that include: the participant to walk barefoot with their normal speed on a 5-mt stretch of plain white paper with inked foot within a fixed time and it was recorded using a stopwatch. Prior to data collection, all participants had an opportunity to practice walking, as first few steps were discarded. The gait parameters analyzed will be step length, stride length, cadence and gait speed
Change in ENERGY EXPENDITURE
Time frame: Baseline and 8th week
The Physiological Cost Index was introduced by MacGregor and is used to check energy expenditure. it is calculated by estimating the speed of walking and the increase in heart rate after the child has walked a specified distance at a self-selected pace. .We calculate the physiological cost index by Formula for calculation PCI is: PCI (beats/min) = Walking heart rate - Resting heart rate / walking speed (m/min)
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 27 Dec 2023.
- Background: PubMed 33637124Valadao P, Piitulainen H, Haapala EA, Parviainen T, Avela J, Finni T. Exercise intervention protocol in children and young adults with cerebral palsy: the effects of strength, flexibility and gait training on physical performance, neuromuscular mechanisms and cardiometabolic risk factors (EXECP). BMC Sports Sci Med Rehabil. 2021 Feb 26;13(1):17. doi: 10.1186/s13102-021-00242-y.
- BackgroundBhilwade1 DAH, DSSGP. Effect of Spasticity on Gait Parameters and Physiological Cost Index in Patients with Spastic Cerebral Palsy. 2020
- Background: PubMed 34407619Merino-Andres J, Garcia de Mateos-Lopez A, Damiano DL, Sanchez-Sierra A. Effect of muscle strength training in children and adolescents with spastic cerebral palsy: A systematic review and meta-analysis. Clin Rehabil. 2022 Jan;36(1):4-14. doi: 10.1177/02692155211040199. Epub 2021 Aug 18.
- 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.
Fareeha Kausar, PP-DPT 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 Conventiional Physiotherapy and Quadriceps Strength Training 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 3 inclusion and 3 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 27 Dec 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?
Change in Gait parameters (time frame: Baseline and 8th 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 NCT05787210, 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 27 Dec 2023.