Effects of Different Time Period of Standing Frame on Spasticity and Gait in Children With Spastic Cerebral Palsy.

Spastic Cerebral Palsy Clinical Trial

Official title:

Effects of Different Time Period of Standing Frame on Spasticity and Gait in Children With Spastic Cerebral Palsy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05113433
• Other study ID #: Anum Shahzadi 159-21
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2021
• Est. completion date: December 10, 2021

Study information

• Verified date: November 2021
• Source: Shifa Tameer-e-Millat University
• Contact: Shafaq Altaf, Phd*
• Phone: 03435020507
• Email: shafaq_dpt.ahs[@]stmu.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 10, 2021
• Est. primary completion date: December 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 14 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Children with knee flexor contractures > 60°.

• Hip flexor contractures > 60°.

• Planter flexor contractures > 30°.

• Severe mental retardation.

Related Conditions & MeSH terms

• Cerebral Palsy
• Gait Disorders, Neurologic
• Muscle Spasticity
• Paralysis
• Spastic Cerebral Palsy
• Spastic Gait

Intervention

Other:
• conventional physical therapy
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.
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 .

Locations

Country	Name	City	State
Pakistan	Shifa tameer e millat university	Islamabad	Federal

Sponsors (1)

Lead Sponsor	Collaborator
Shifa Tameer-e-Millat University

Country where clinical trial is conducted

Pakistan, 

References & Publications (11)

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. — View Citation

Bar-On L, Molenaers G, Aertbeliën 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. Review. — View Citation

Bearden 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. — View Citation

Blackmore 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. Review. — View Citation

Capati 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. — View Citation

Caulton 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. — View Citation

Dalembert 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. Review. — View Citation

Duke 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. — View Citation

Elnaggar 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. — View Citation

Franki 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. Review. — View Citation

Goodwin 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Primary	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.	4 weeks