NCT05113433

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 2, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 9, 2021

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2021

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
Last Updated

November 10, 2021

Status Verified

November 1, 2021

Enrollment Period

1 month

First QC Date

November 2, 2021

Last Update Submit

November 9, 2021

Conditions

Keywords

Cerebral PalsyModified Ashworth scale6 minute walk test

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (4)

group a

EXPERIMENTAL

15 minute on standing frame .

Other: conventional physical therapyOther: standing frame.

group b

EXPERIMENTAL

30 minute on standing frame .

Other: conventional physical therapyOther: standing frame.

group c

EXPERIMENTAL

45 minute on standing frame.

Other: conventional physical therapyOther: standing frame.

group d

EXPERIMENTAL

60 minute on standing frame.

Other: conventional physical therapyOther: standing frame.

Interventions

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.

group agroup bgroup cgroup d

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 .

group agroup bgroup cgroup d

Eligibility Criteria

Age4 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Children with knee flexor contractures \> 60°.
  • Hip flexor contractures \> 60°.
  • Planter flexor contractures \> 30°.
  • Severe mental retardation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shifa tameer e millat university

Islamabad, Federal, 44000, Pakistan

RECRUITING

Related 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.

    PMID: 28071965BACKGROUND
  • Bar-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.

    PMID: 25649546BACKGROUND
  • 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.

    PMID: 27114082BACKGROUND
  • 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. doi: 10.1111/j.1469-8749.2007.00781.x.

    PMID: 17880650BACKGROUND
  • 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.

    PMID: 30945990BACKGROUND
  • 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. doi: 10.1136/adc.2002.009316.

    PMID: 14736627BACKGROUND
  • 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.

    PMID: 23751888BACKGROUND
  • 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.

    PMID: 31291989BACKGROUND
  • 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.

    PMID: 31789302BACKGROUND
  • 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.

    PMID: 31777043BACKGROUND
  • 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.

    PMID: 30234480BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shafaq Altaf, Phd*

    Shifa tameer e millat university Islamabad

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shafaq Altaf, Phd*

CONTACT

Nouman Khan, MS-OMPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 2, 2021

First Posted

November 9, 2021

Study Start

November 2, 2021

Primary Completion

December 2, 2021

Study Completion

December 10, 2021

Last Updated

November 10, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations