Spastic Cerebral PalsyNCT04858646
Aerobic Exercises and Gross Motor Function in Spastic Cerebral Palsy
A study testing Experimental( Group A ): Aerobic exercises and Conventional( Group B): Conventional Physical therapy in people with Spastic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this research is to find the effects of aerobic exercise on gross motor function in cerebral palsy patients. Quasai experimental study done at Noor Zainab Rehabilitation center, Lahore. The sample size was 34. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- Experimental( Group A ): Aerobic exercises and Conventional( Group B): Conventional Physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2019to 30 Jun 2019
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with CP at GMFCS level I- III
Who cannot join
- Botulinum toxin-A- injection in lower limb last 6 months
- <0° dorsiflexion in ankle
- Unable to cooperate and follow instructions
- Children with progressive brain disorder
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Aerobic Exercises on Gross Motor Function in Children With Spastic Cerebral Palsy
The aim of this research is to find the effects of aerobic exercise on gross motor function in cerebral palsy patients. Quasai experimental study done at Noor Zainab Rehabilitation center, Lahore. The sample size was 34. The subjects were divided in two groups, 17 subjects with aerobic exercise 17 children with conventional treatment. Sampling technique applied was purposive non probability sampling. Only 7-12 years individuals with GMFCS level I- III were included. Tools used in the study were Gross motor function measure (GMFM-66 and 88) .Data was be analyzed through SPSS 21.
Read the detailed description
Cerebral palsy" an umbrella term for a group of irreversible and non-progressive abnormalities of the fetal or neonatal brain, this can lead to disorders of movement and posture. National Institute for Health and Care Excellence (NICE) states that, it is the most common cause of physical disability in children and young people in the developing world. CP is condition with multiple causes; multiple clinical types; multiple associated developmental pathologies, such as intellectual disability, autism, epilepsy, and visual impairment; and more recently multiple rare pathogenic genetic variations Motor disability in cerebral palsy is related with sitting, standing, walking and running appears as the main symptom in children with CP, the assessment and management of CP have focused on gross motor function. The Gross Motor Function Measure (GMFM) is designed by Russell et al. in 1993 is used to measure the level of motor development and changes of gross motor function in a standardized environment in children with CP. GMFM-66 is comprised of a subset of the 88 items identified as contributing to the measure of gross motor function in children with CP, ranging from 0 (lowest motor function) to 100 (highest motor function). Cardiorespiratory endurance is an integral component of physical fitness and has been identified as the most important fitness component associated with health and mortality. In clinical practice, rebound is usually offered as a 20 minute session, once per week for 6 weeks. Typical rebound therapy programs target gross motor skill development, such as balance while sitting, kneeling, standing and walking; functional transfers such as rolling and sit to stand; aerobic activity such as jumping. It is theorized that using a trampoline improves muscle tone, posture, balance, kinesthetic awareness, movement, body awareness, and communication. Aerobic exercise may improve activity as indicated by motor function but does not appear to improve gait speed, walking endurance, participation or aerobic fitness among children with CP in the short or intermediate term. Researcher to conduct a study on effects of robot assisted gait training in CP children, collect data from 14 consecutive children affected by CP, each session of 60 minutes, 20 daily sessions for 5 days per week. Saeid Fatorehchy et al. in 2019 conducted an RCT, this study was to evaluate the effects of aquatic therapy in cerebral palsy patients. Six children with average age of 7 years 4 months are included. Each sessions lasted for 50 minutes, comprising 10 minutes of warm up and stretching and 40 minutes of walking in pool at different at different water depths.
Maria A. Fragala-Pinkham et al. stated that participation in routine physical activity is important for health promotion and prevention of chronic health condition. Participating in sports and active recreation can be beneficial on several levels for children and adults with CP. At the body function and structure level of the ICF, improvement in fitness and endurance have been documented for children and young with CP. Sports equipment that can be use are cycling, swimming, sketching and outdoor active recreation.
- Conditions
- Spastic Cerebral Palsy
- Being tested
- Experimental( Group A ): Aerobic exercises, Conventional( Group B): Conventional Physical therapy
- Keywords
- Cerebral palsy, Gross motor function measure, Aerobic 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.
Experimental( Group A ): Aerobic exercisesOther
Subjects in A group was treated with different types of aerobic exercises such as 10 minute walking, 10 minute trampoline exercise and 10 minutes ball throwing activities
Conventional( Group B): Conventional Physical therapyOther
The group B was treated with conventional therapy. Conventional treatment protocol passive ROM and stretching passive ROM for 15 minutes and stretching for 15 minutes.Treatment duration for both groups will be 30 minutes. Each subject received total30sessions of the treatment, with 5 treatment sessions per week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercises | Experimental | Subjects in A group was treated with different types of aerobic exercises such as 10 minute walking, 10 minute trampoline exercise and 10 minutes ball throwing activities Receives: Other: Experimental( Group A ): Aerobic exercises |
| Conventional physical therapy | Active comparator | Traditional physical therapy The group B was treated with conventional therapy. Conventional treatment protocol passive ROM and stretching passive ROM for 15 minutes and stretching for 15 minutes. Treatment duration for both groups will be 30 minutes. Each subject received total 30 sessions of the treatment, with 5 treatment sessions per week for 6 weeks. Post treatment reading were collected after end of 6th weeks. Receives: Other: Conventional( Group B): Conventional Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross motor function measure (GMFM-66 and 88)
The Gross Motor Function Measure (GMFM) is an observational clinical tool designed to evaluate change in gross motor function in children with cerebral palsy. There are two versions of the GMFM - the original 88-item measure (GMFM-88) and the more recent 66-item GMFM (GMFM-66) The scoring system of the GMFM is a four-point scale divided into five categories (lying and rolling; sitting; crawling and kneeling; standing; walking, running).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start15 Jan 2019
- Primary completion20 Jun 2019
- Study completion30 Jun 2019
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 Spastic 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tehreem Mukhtar, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858646
- Sponsor's protocol ID
- REC/Lhr/19/2021 Hira Nawaz
- Status last verified
- Apr 2021
- First submitted
- 30 Mar 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kwon TG, Yi SH, Kim TW, Chang HJ, Kwon JY. Relationship between gross motor function and daily functional skill in children with cerebral palsy. Ann Rehabil Med. 2013 Feb;37(1):41-9. doi: 10.5535/arm.2013.37.1.41. Epub 2013 Feb 28.
PubMed 23525125MacLennan AH, Thompson SC, Gecz J. Cerebral palsy: causes, pathways, and the role of genetic variants. Am J Obstet Gynecol. 2015 Dec;213(6):779-88. doi: 10.1016/j.ajog.2015.05.034. Epub 2015 May 21.
PubMed 26003063Lauglo R, Vik T, Lamvik T, Stensvold D, Finbraten AK, Moholdt T. High-intensity interval training to improve fitness in children with cerebral palsy. BMJ Open Sport Exerc Med. 2016 May 9;2(1):e000111. doi: 10.1136/bmjsem-2016-000111. eCollection 2016.
PubMed 27900177Kim OY, Shin YK, Yoon YK, Ko EJ, Cho SR. The effect of treadmill exercise on gait efficiency during overground walking in adults with cerebral palsy. Ann Rehabil Med. 2015 Feb;39(1):25-31. doi: 10.5535/arm.2015.39.1.25. Epub 2015 Feb 28.
PubMed 25750868Balemans AC, Van Wely L, De Heer SJ, Van den Brink J, De Koning JJ, Becher JG, Dallmeijer AJ. Maximal aerobic and anaerobic exercise responses in children with cerebral palsy. Med Sci Sports Exerc. 2013 Mar;45(3):561-8. doi: 10.1249/MSS.0b013e3182732b2f.
PubMed 23034639Verschuren O, Darrah J, Novak I, Ketelaar M, Wiart L. Health-enhancing physical activity in children with cerebral palsy: more of the same is not enough. Phys Ther. 2014 Feb;94(2):297-305. doi: 10.2522/ptj.20130214. Epub 2013 Oct 3.
PubMed 24092902Ryan JM, Cassidy EE, Noorduyn SG, O'Connell NE. Exercise interventions for cerebral palsy. Cochrane Database Syst Rev. 2017 Jun 11;6(6):CD011660. doi: 10.1002/14651858.CD011660.pub2.
PubMed 28602046Digiacomo F, Tamburin S, Tebaldi S, Pezzani M, Tagliafierro M, Casale R, Bartolo M. Improvement of motor performance in children with cerebral palsy treated with exoskeleton robotic training: A retrospective explorative analysis. Restor Neurol Neurosci. 2019;37(3):239-244. doi: 10.3233/RNN-180897.
PubMed 31177250Gillett JG, Lichtwark GA, Boyd RN, Barber LA. Functional Anaerobic and Strength Training in Young Adults with Cerebral Palsy. Med Sci Sports Exerc. 2018 Aug;50(8):1549-1557. doi: 10.1249/MSS.0000000000001614.
PubMed 29557839
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercises on Gross Motor Function in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04858646
- Acronym / sponsor ID
- REC/Lhr/19/2021 Hira Nawaz
- Conditions
- Spastic Cerebral Palsy
- Keywords
- Cerebral palsy, Gross motor function measure, Aerobic exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 26 Apr 2021 (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 research is to find the effects of aerobic exercise on gross motor function in cerebral palsy patients. Quasai experimental study done at Noor Zainab Rehabilitation center, Lahore. The sample size was 34. The subjects were divided in two groups, 17 subjects with aerobic exercise 17 children with conventional treatment. Sampling technique applied was purposive non probability sampling. Only 7-12 years individuals with GMFCS level I- III were included. Tools used in the study were Gross motor function measure (GMFM-66 and 88) .Data was be analyzed through SPSS 21.
Detailed description
Cerebral palsy" an umbrella term for a group of irreversible and non-progressive abnormalities of the fetal or neonatal brain, this can lead to disorders of movement and posture. National Institute for Health and Care Excellence (NICE) states that, it is the most common cause of physical disability in children and young people in the developing world. CP is condition with multiple causes; multiple clinical types; multiple associated developmental pathologies, such as intellectual disability, autism, epilepsy, and visual impairment; and more recently multiple rare pathogenic genetic variations Motor disability in cerebral palsy is related with sitting, standing, walking and running appears as the main symptom in children with CP, the assessment and management of CP have focused on gross motor function. The Gross Motor Function Measure (GMFM) is designed by Russell et al. in 1993 is used to measure the level of motor development and changes of gross motor function in a standardized environment in children with CP. GMFM-66 is comprised of a subset of the 88 items identified as contributing to the measure of gross motor function in children with CP, ranging from 0 (lowest motor function) to 100 (highest motor function). Cardiorespiratory endurance is an integral component of physical fitness and has been identified as the most important fitness component associated with health and mortality. In clinical practice, rebound is usually offered as a 20 minute session, once per week for 6 weeks. Typical rebound therapy programs target gross motor skill development, such as balance while sitting, kneeling, standing and walking; functional transfers such as rolling and sit to stand; aerobic activity such as jumping. It is theorized that using a trampoline improves muscle tone, posture, balance, kinesthetic awareness, movement, body awareness, and communication. Aerobic exercise may improve activity as indicated by motor function but does not appear to improve gait speed, walking endurance, participation or aerobic fitness among children with CP in the short or intermediate term. Researcher to conduct a study on effects of robot assisted gait training in CP children, collect data from 14 consecutive children affected by CP, each session of 60 minutes, 20 daily sessions for 5 days per week. Saeid Fatorehchy et al. in 2019 conducted an RCT, this study was to evaluate the effects of aquatic therapy in cerebral palsy patients. Six children with average age of 7 years 4 months are included. Each sessions lasted for 50 minutes, comprising 10 minutes of warm up and stretching and 40 minutes of walking in pool at different at different water depths.
Maria A. Fragala-Pinkham et al. stated that participation in routine physical activity is important for health promotion and prevention of chronic health condition. Participating in sports and active recreation can be beneficial on several levels for children and adults with CP. At the body function and structure level of the ICF, improvement in fitness and endurance have been documented for children and young with CP. Sports equipment that can be use are cycling, swimming, sketching and outdoor active recreation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercises | Experimental | Other: Experimental( Group A ): Aerobic exercisesSubjects in A group was treated with different types of aerobic exercises such as 10 minute walking, 10 minute trampoline exercise and 10 minutes ball throwing activities |
| Conventional physical therapy | Active comparator | Other: Conventional( Group B): Conventional Physical therapyTraditional physical therapy The group B was treated with conventional therapy. Conventional treatment protocol passive ROM and stretching passive ROM for 15 minutes and stretching for 15 minutes. Treatment duration for both groups will be 30 minutes. Each subject received total 30 sessions of the treatment, with 5 treatment sessions per week for 6 weeks. Post treatment reading were collected after end of 6th weeks. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with CP at GMFCS level I- III
Key exclusion criteria (4 listed)
- Botulinum toxin-A- injection in lower limb last 6 months
- <0° dorsiflexion in ankle
- Unable to cooperate and follow instructions
- Children with progressive brain disorder
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 |
|---|---|---|
| Experimental( Group A ): Aerobic exercisesSubjects in A group was treated with different types of aerobic exercises such as 10 minute walking, 10 minute trampoline exercise and 10 minutes ball throwing activities | Other | Aerobic exercises |
| Conventional( Group B): Conventional Physical therapyThe group B was treated with conventional therapy. Conventional treatment protocol passive ROM and stretching passive ROM for 15 minutes and stretching for 15 minutes.Treatment duration for both groups will be 30 minutes. Each subject received total30sessions of the treatment, with 5 treatment sessions per week for 6 weeks | Other | Conventional physical therapy |
Primary outcome
Gross motor function measure (GMFM-66 and 88)
Time frame: 3 months
The Gross Motor Function Measure (GMFM) is an observational clinical tool designed to evaluate change in gross motor function in children with cerebral palsy. There are two versions of the GMFM - the original 88-item measure (GMFM-88) and the more recent 66-item GMFM (GMFM-66) The scoring system of the GMFM is a four-point scale divided into five categories (lying and rolling; sitting; crawling and kneeling; standing; walking, running).
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 26 Apr 2021.
- Background: PubMed 23525125Kwon TG, Yi SH, Kim TW, Chang HJ, Kwon JY. Relationship between gross motor function and daily functional skill in children with cerebral palsy. Ann Rehabil Med. 2013 Feb;37(1):41-9. doi: 10.5535/arm.2013.37.1.41. Epub 2013 Feb 28.
- Background: PubMed 26003063MacLennan AH, Thompson SC, Gecz J. Cerebral palsy: causes, pathways, and the role of genetic variants. Am J Obstet Gynecol. 2015 Dec;213(6):779-88. doi: 10.1016/j.ajog.2015.05.034. Epub 2015 May 21.
- Background: PubMed 27900177Lauglo R, Vik T, Lamvik T, Stensvold D, Finbraten AK, Moholdt T. High-intensity interval training to improve fitness in children with cerebral palsy. BMJ Open Sport Exerc Med. 2016 May 9;2(1):e000111. doi: 10.1136/bmjsem-2016-000111. eCollection 2016.
- Background: PubMed 25750868Kim OY, Shin YK, Yoon YK, Ko EJ, Cho SR. The effect of treadmill exercise on gait efficiency during overground walking in adults with cerebral palsy. Ann Rehabil Med. 2015 Feb;39(1):25-31. doi: 10.5535/arm.2015.39.1.25. Epub 2015 Feb 28.
- Background: PubMed 23034639Balemans AC, Van Wely L, De Heer SJ, Van den Brink J, De Koning JJ, Becher JG, Dallmeijer AJ. Maximal aerobic and anaerobic exercise responses in children with cerebral palsy. Med Sci Sports Exerc. 2013 Mar;45(3):561-8. doi: 10.1249/MSS.0b013e3182732b2f.
- Background: PubMed 24092902Verschuren O, Darrah J, Novak I, Ketelaar M, Wiart L. Health-enhancing physical activity in children with cerebral palsy: more of the same is not enough. Phys Ther. 2014 Feb;94(2):297-305. doi: 10.2522/ptj.20130214. Epub 2013 Oct 3.
- Background: PubMed 28602046Ryan JM, Cassidy EE, Noorduyn SG, O'Connell NE. Exercise interventions for cerebral palsy. Cochrane Database Syst Rev. 2017 Jun 11;6(6):CD011660. doi: 10.1002/14651858.CD011660.pub2.
- Background: PubMed 31177250Digiacomo F, Tamburin S, Tebaldi S, Pezzani M, Tagliafierro M, Casale R, Bartolo M. Improvement of motor performance in children with cerebral palsy treated with exoskeleton robotic training: A retrospective explorative analysis. Restor Neurol Neurosci. 2019;37(3):239-244. doi: 10.3233/RNN-180897.
- Background: PubMed 29557839Gillett JG, Lichtwark GA, Boyd RN, Barber LA. Functional Anaerobic and Strength Training in Young Adults with Cerebral Palsy. Med Sci Sports Exerc. 2018 Aug;50(8):1549-1557. doi: 10.1249/MSS.0000000000001614.
- 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.
Tehreem Mukhtar, 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 Experimental( Group A ): Aerobic exercises and Conventional( Group B): Conventional Physical therapy in people with Spastic 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 1 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 26 Apr 2021. 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?
Gross motor function measure (GMFM-66 and 88) (time frame: 3 months). 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 NCT04858646, 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 26 Apr 2021.