Spastic Cerebral PalsyNCT05113433
Effects of Different Time Period of Standing Frame on Spasticity and Gait in Children With Spastic Cerebral Palsy.
A study testing conventional physical therapy and standing frame. in people with Spastic Cerebral Palsy and Spastic Gait, run by Shifa Tameer-e-Millat University at 1 site in Pakistan.
Trial summary
Cerebral palsy is a neurological disorder with abnormalities in muscle tone, movement disorders and motor incapability. It attributes to harm to the growing brain. Cerebral approach including brain and its palsy referred to weakness and problems while using the muscles. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Spastic Cerebral Palsy, Spastic Gait
- What is being tested?
- conventional physical therapy and standing frame.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Nov 2021to 10 Dec 2021
- 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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Spastic CP with age limit between 4-14 years.
- Both genders.
- At least 40° knee flexion.
- Sitting achieved on ground.
- mass at least with grade 3.
Who cannot join
- Children with knee flexor contractures > 60°.
- Hip flexor contractures > 60°.
- Planter flexor contractures > 30°.
- Severe mental retardation.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Shifa tameer e millat university
Islamabad, Federal, 44000
Shafaq Altaf, Phd*, 03435020507, shafaq_dpt.ahs@stmu.edu.pk
Nouman Khan, Ms- OMPT, 03339378324, nouman_drs.ahs@stmu.edu.pk
About this study
Cerebral palsy is a neurological disorder with abnormalities in muscle tone, movement disorders and motor incapability. It attributes to harm to the growing brain. Cerebral approach including brain and its palsy referred to weakness and problems while using the muscles. It is characterized by way of the incapability to normally control motor features, and it has. the capacity to have an impact on the general improvement of a child with the aid of affecting the child's capability to explore, talk, learn, and grow to be independent. Spastic CP is the most common type among children and debts for almost 77% among all instances. It is the major problem in CP child making movement difficult or even impossible.
Read the detailed description
Cerebral palsy itself is not considered as a. progressive disease rather it is a medical. expression that may trade with time as the brain grows. It is attributed as the physical disability that is commonly present in children whose diagnosis can be made. before 6 months. Cerebral palsy is mostly considered as the commonplace physical incapacity among children .and it impacts almost 2 -2.5/1000 children born in United State of America. Population based information displays that the percentage of intense cases of CP is very high among low and middle earned international countries. Children with CP born in low offerings .Children with cerebral palsy mostly have spastic syndrome in common. Prolong sustain stretch is an effective treatment traditionally used to reduce spasticity. We can use the effect of frame and gravity or automatically, the usage of device or splints to carry out sustain stretch manually. A standing frame is a mechanical (vintage) or mechatronic (new) equipment, that has as principal aim to accurate the incapacity of certain individual for assuming the body's vertical position.
The type of cerebral palsy relies upon on the kind of movement disorders in children affecting the body parts. The classification of CP which is topographically involves:
Quadriplegic Hemiplegic Diplegic Monoplegic And triplegic cerebral palsy Clinical history may help an early diagnosis which involves the use of neuroimaging, standardized tests with neurological and motor aspects which indicates congruent ordinary findings indicating cerebral palsy. The importance of spark off referral need to be recognized by the clinicians to be specifically diagnostic before the start of intervention so that treatment can be optimized for the prevention of secondary complications. Types of CP contributes in the early diagnosis with presence of epilepsy, a larger degree of motor incapacity, and cerebral abnormalities in ultrasonography. There is no association between gestational and diagnostic age. Neuroimaging is presently endorsed as a general assessment. MRI showing excessive abnormality in white matter had a strong association with CP as compared to general movements present .MRI with respect to its diagnostic value is not as better as consecutive ultrasonography, the reason behind this fact is that MRI is much demanding, but MRI in daily routine is not going to turn out as a standard exercise.
- Conditions
- Spastic Cerebral Palsy, Spastic Gait
- Being tested
- conventional physical therapy, standing frame.
- Keywords
- Cerebral Palsy, Modified Ashworth scale, 6 minute walk test
- Medical subject headings
- Cerebral Palsy, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional physical therapyOther
muscle strengthening i.e. isometrics of lower limb muscles. 5 sets/rep and 2 sets/ session.
stretching of lower limb muscles . 5sets/rep and 2 sets/session.
standing frame.Other
muscle strengthening i.e. isometrics of lower limb muscles. 5 sets/rep and 2 sets/ session.
stretching of lower limb muscles . 5sets/rep and 2 sets/session. sanding on standing frame for different time period according to group with upper limb activities lie box and blocks , cones and theraputty .
| Study group | Role | What they receive |
|---|---|---|
| group a | Experimental | 15 minute on standing frame . Receives: Other: conventional physical therapy; Other: standing frame. |
| group b | Experimental | 30 minute on standing frame . Receives: Other: conventional physical therapy; Other: standing frame. |
| group c | Experimental | 45 minute on standing frame. Receives: Other: conventional physical therapy; Other: standing frame. |
| group d | Experimental | 60 minute on standing frame. Receives: Other: conventional physical therapy; Other: standing frame. |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified ashworth scale.
mas used to assess spasticity of lower limb muscles bilaterally i.e. hip flexors, hip extensors hip abductors hip adductors , ankle dorsiflexors and ankle planter flexiors.
Measured: 4 weeks
6 minute walk test.
6 minute walk test to assess gait. walk for 6 minute . children can take rest but time will not be stopped. measure distance in meters.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start2 Nov 2021 (estimated)
- Primary completion2 Dec 2021 (estimated)
- Study completion10 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Spastic 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shifa Tameer-e-Millat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouman Khan, Shifa Tameer-e-Millat University
- Investigators
- Shafaq Altaf, Phd*, Principal investigator, Shifa Tameer-e-Millat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113433
- Sponsor's protocol ID
- Anum Shahzadi 159-21
- Status last verified
- Nov 2021
- First submitted
- 2 Nov 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Audu O, Daly C. Standing activity intervention and motor function in a young child with cerebral palsy: A case report. Physiother Theory Pract. 2017 Feb;33(2):162-172. doi: 10.1080/09593985.2016.1265621. Epub 2017 Jan 10.
PubMed 28071965Bar-On L, Molenaers G, Aertbelien E, Van Campenhout A, Feys H, Nuttin B, Desloovere K. Spasticity and its contribution to hypertonia in cerebral palsy. Biomed Res Int. 2015;2015:317047. doi: 10.1155/2015/317047. Epub 2015 Jan 11.
PubMed 25649546Bearden DR, Monokwane B, Khurana E, Baier J, Baranov E, Westmoreland K, Mazhani L, Steenhoff AP. Pediatric Cerebral Palsy in Botswana: Etiology, Outcomes, and Comorbidities. Pediatr Neurol. 2016 Jun;59:23-9. doi: 10.1016/j.pediatrneurol.2016.03.002. Epub 2016 Mar 17.
PubMed 27114082Blackmore AM, Boettcher-Hunt E, Jordan M, Chan MD. A systematic review of the effects of casting on equinus in children with cerebral palsy: an evidence report of the AACPDM. Dev Med Child Neurol. 2007 Oct;49(10):781-90. doi: 10.1111/j.1469-8749.2007.00781.x.
PubMed 17880650Capati V, Covert SY, Paleg G. Stander Use for an Adolescent with Cerebral Palsy at GMFCS Level with Hip and Knee Contractures. Assist Technol. 2020 Nov 1;32(6):335-341. doi: 10.1080/10400435.2019.1579268. Epub 2019 Apr 4.
PubMed 30945990Caulton JM, Ward KA, Alsop CW, Dunn G, Adams JE, Mughal MZ. A randomised controlled trial of standing programme on bone mineral density in non-ambulant children with cerebral palsy. Arch Dis Child. 2004 Feb;89(2):131-5. doi: 10.1136/adc.2002.009316.
PubMed 14736627Dalembert G, Brosco JP. Do politics affect prevalence? An overview and the case of cerebral palsy. J Dev Behav Pediatr. 2013 Jun;34(5):369-74. doi: 10.1097/DBP.0b013e31829455d8.
PubMed 23751888Duke R, Eyong K, Burton K, MacLeod D, Dutton GN, Gilbert C, Bowman R. The effect of visual support strategies on the quality of life of children with cerebral palsy and cerebral visual impairment/perceptual visual dysfunction in Nigeria: study protocol for a randomized controlled trial. Trials. 2019 Jul 10;20(1):417. doi: 10.1186/s13063-019-3527-9.
PubMed 31291989Elnaggar RK, Elbanna MF, Mahmoud WS, Alqahtani BA. Plyometric exercises: subsequent changes of weight-bearing symmetry, muscle strength and walking performance in children with unilateral cerebral palsy. J Musculoskelet Neuronal Interact. 2019 Dec 1;19(4):507-515.
PubMed 31789302Franki I, Bar-On L, Molenaers G, Van Campenhout A, Craenen K, Desloovere K, Feys H, Pauwels P, De Cat J, Ortibus E. Tone Reduction and Physical Therapy: Strengthening Partners in Treatment of Children with Spastic Cerebral Palsy. Neuropediatrics. 2020 Apr;51(2):89-104. doi: 10.1055/s-0039-3400987. Epub 2019 Nov 27.
PubMed 31777043Goodwin J, Lecouturier J, Basu A, Colver A, Crombie S, Smith J, Howel D, McColl E, Parr JR, Kolehmainen N, Roberts A, Miller K, Cadwgan J. Standing frames for children with cerebral palsy: a mixed-methods feasibility study. Health Technol Assess. 2018 Sep;22(50):1-232. doi: 10.3310/hta22500.
PubMed 30234480
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Time Period of Standing Frame on Spasticity and Gait in Children With Spastic Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT05113433
- Acronym / sponsor ID
- Anum Shahzadi 159-21
- Conditions
- Spastic Cerebral Palsy, Spastic Gait
- Keywords
- Cerebral Palsy, Modified Ashworth scale, 6 minute walk test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shifa Tameer-e-Millat UniversityUniversity, hospital or other
- Study start
- 2 Nov 2021 (estimated)
- Primary completion
- 2 Dec 2021 (estimated)
- Study completion
- 10 Dec 2021 (estimated)
- First posted
- 9 Nov 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.
Cerebral palsy is a neurological disorder with abnormalities in muscle tone, movement disorders and motor incapability. It attributes to harm to the growing brain. Cerebral approach including brain and its palsy referred to weakness and problems while using the muscles. It is characterized by way of the incapability to normally control motor features, and it has. the capacity to have an impact on the general improvement of a child with the aid of affecting the child's capability to explore, talk, learn, and grow to be independent. Spastic CP is the most common type among children and debts for almost 77% among all instances. It is the major problem in CP child making movement difficult or even impossible.
Detailed description
Cerebral palsy itself is not considered as a. progressive disease rather it is a medical. expression that may trade with time as the brain grows. It is attributed as the physical disability that is commonly present in children whose diagnosis can be made. before 6 months. Cerebral palsy is mostly considered as the commonplace physical incapacity among children .and it impacts almost 2 -2.5/1000 children born in United State of America. Population based information displays that the percentage of intense cases of CP is very high among low and middle earned international countries. Children with CP born in low offerings .Children with cerebral palsy mostly have spastic syndrome in common. Prolong sustain stretch is an effective treatment traditionally used to reduce spasticity. We can use the effect of frame and gravity or automatically, the usage of device or splints to carry out sustain stretch manually. A standing frame is a mechanical (vintage) or mechatronic (new) equipment, that has as principal aim to accurate the incapacity of certain individual for assuming the body's vertical position.
The type of cerebral palsy relies upon on the kind of movement disorders in children affecting the body parts. The classification of CP which is topographically involves:
Quadriplegic Hemiplegic Diplegic Monoplegic And triplegic cerebral palsy Clinical history may help an early diagnosis which involves the use of neuroimaging, standardized tests with neurological and motor aspects which indicates congruent ordinary findings indicating cerebral palsy. The importance of spark off referral need to be recognized by the clinicians to be specifically diagnostic before the start of intervention so that treatment can be optimized for the prevention of secondary complications. Types of CP contributes in the early diagnosis with presence of epilepsy, a larger degree of motor incapacity, and cerebral abnormalities in ultrasonography. There is no association between gestational and diagnostic age. Neuroimaging is presently endorsed as a general assessment. MRI showing excessive abnormality in white matter had a strong association with CP as compared to general movements present .MRI with respect to its diagnostic value is not as better as consecutive ultrasonography, the reason behind this fact is that MRI is much demanding, but MRI in daily routine is not going to turn out as a standard exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group a | Experimental | Other: conventional physical therapy, Other: standing frame.15 minute on standing frame . |
| group b | Experimental | Other: conventional physical therapy, Other: standing frame.30 minute on standing frame . |
| group c | Experimental | Other: conventional physical therapy, Other: standing frame.45 minute on standing frame. |
| group d | Experimental | Other: conventional physical therapy, Other: standing frame.60 minute on standing frame. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Spastic CP with age limit between 4-14 years.
- Both genders.
- At least 40° knee flexion.
- Sitting achieved on ground.
- mass at least with grade 3.
Key exclusion criteria (4 listed)
- Children with knee flexor contractures > 60°.
- Hip flexor contractures > 60°.
- Planter flexor contractures > 30°.
- Severe mental retardation.
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 |
|---|---|---|
| conventional physical therapymuscle strengthening i.e. isometrics of lower limb muscles. 5 sets/rep and 2 sets/ session. stretching of lower limb muscles . 5sets/rep and 2 sets/session. | Other | group a, group b, group c, group d |
| standing frame.muscle strengthening i.e. isometrics of lower limb muscles. 5 sets/rep and 2 sets/ session. stretching of lower limb muscles . 5sets/rep and 2 sets/session. sanding on standing frame for different time period according to group with upper limb activities lie box and blocks , cones and theraputty . | Other | group a, group b, group c, group d |
Primary outcome
modified ashworth scale.
Time frame: 4 weeks
mas used to assess spasticity of lower limb muscles bilaterally i.e. hip flexors, hip extensors hip abductors hip adductors , ankle dorsiflexors and ankle planter flexiors.
6 minute walk test.
Time frame: 4 weeks
6 minute walk test to assess gait. walk for 6 minute . children can take rest but time will not be stopped. measure distance in meters.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Background: PubMed 28071965Audu O, Daly C. Standing activity intervention and motor function in a young child with cerebral palsy: A case report. Physiother Theory Pract. 2017 Feb;33(2):162-172. doi: 10.1080/09593985.2016.1265621. Epub 2017 Jan 10.
- Background: PubMed 25649546Bar-On L, Molenaers G, Aertbelien E, Van Campenhout A, Feys H, Nuttin B, Desloovere K. Spasticity and its contribution to hypertonia in cerebral palsy. Biomed Res Int. 2015;2015:317047. doi: 10.1155/2015/317047. Epub 2015 Jan 11.
- Background: PubMed 27114082Bearden DR, Monokwane B, Khurana E, Baier J, Baranov E, Westmoreland K, Mazhani L, Steenhoff AP. Pediatric Cerebral Palsy in Botswana: Etiology, Outcomes, and Comorbidities. Pediatr Neurol. 2016 Jun;59:23-9. doi: 10.1016/j.pediatrneurol.2016.03.002. Epub 2016 Mar 17.
- Background: PubMed 17880650Blackmore AM, Boettcher-Hunt E, Jordan M, Chan MD. A systematic review of the effects of casting on equinus in children with cerebral palsy: an evidence report of the AACPDM. Dev Med Child Neurol. 2007 Oct;49(10):781-90. doi: 10.1111/j.1469-8749.2007.00781.x.
- Background: PubMed 30945990Capati V, Covert SY, Paleg G. Stander Use for an Adolescent with Cerebral Palsy at GMFCS Level with Hip and Knee Contractures. Assist Technol. 2020 Nov 1;32(6):335-341. doi: 10.1080/10400435.2019.1579268. Epub 2019 Apr 4.
- Background: PubMed 14736627Caulton JM, Ward KA, Alsop CW, Dunn G, Adams JE, Mughal MZ. A randomised controlled trial of standing programme on bone mineral density in non-ambulant children with cerebral palsy. Arch Dis Child. 2004 Feb;89(2):131-5. doi: 10.1136/adc.2002.009316.
- Background: PubMed 23751888Dalembert G, Brosco JP. Do politics affect prevalence? An overview and the case of cerebral palsy. J Dev Behav Pediatr. 2013 Jun;34(5):369-74. doi: 10.1097/DBP.0b013e31829455d8.
- Background: PubMed 31291989Duke R, Eyong K, Burton K, MacLeod D, Dutton GN, Gilbert C, Bowman R. The effect of visual support strategies on the quality of life of children with cerebral palsy and cerebral visual impairment/perceptual visual dysfunction in Nigeria: study protocol for a randomized controlled trial. Trials. 2019 Jul 10;20(1):417. doi: 10.1186/s13063-019-3527-9.
- Background: PubMed 31789302Elnaggar RK, Elbanna MF, Mahmoud WS, Alqahtani BA. Plyometric exercises: subsequent changes of weight-bearing symmetry, muscle strength and walking performance in children with unilateral cerebral palsy. J Musculoskelet Neuronal Interact. 2019 Dec 1;19(4):507-515.
- Background: PubMed 31777043Franki I, Bar-On L, Molenaers G, Van Campenhout A, Craenen K, Desloovere K, Feys H, Pauwels P, De Cat J, Ortibus E. Tone Reduction and Physical Therapy: Strengthening Partners in Treatment of Children with Spastic Cerebral Palsy. Neuropediatrics. 2020 Apr;51(2):89-104. doi: 10.1055/s-0039-3400987. Epub 2019 Nov 27.
- Background: PubMed 30234480Goodwin J, Lecouturier J, Basu A, Colver A, Crombie S, Smith J, Howel D, McColl E, Parr JR, Kolehmainen N, Roberts A, Miller K, Cadwgan J. Standing frames for children with cerebral palsy: a mixed-methods feasibility study. Health Technol Assess. 2018 Sep;22(50):1-232. doi: 10.3310/hta22500.
- 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.
Shafaq Altaf, Phd* principal investigator
Shifa Tameer-e-Millat 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 conventional physical therapy and standing frame. in people with Spastic Cerebral Palsy and Spastic Gait, run by Shifa Tameer-e-Millat 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 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: status not confirmed, as of the sponsor's last update on 10 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shafaq Altaf, Phd* (03435020507, shafaq_dpt.ahs@stmu.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified ashworth scale. (time frame: 4 weeks). 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 NCT05113433, which also lists 11 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 Nov 2021.