NCT04755556

Brief Summary

Effectiveness of Routine Physical Therapy With or Without Home Based Intensive Bimanual Training on Clinical Outcomes in Cerebral Palsy Children

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 6, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

9 months

First QC Date

February 10, 2021

Last Update Submit

February 10, 2021

Conditions

Keywords

Cerebral PalsyBimanual Training

Outcome Measures

Primary Outcomes (1)

  • ABILHAND

    hand coordination

    6th week

Secondary Outcomes (1)

  • Pediatric Motor Log Activity Scale

    6th week

Study Arms (2)

Experimental group

OTHER

Intensive bimanual training with routine physical therapy

Other: home based intensive bimanual training

control group

OTHER

routine physical therapy

Other: Routine Physical Therapy

Interventions

Home Based Intensive Bimanual Training with Routine Physical Therapy bimanual training includes. functional activities play with ball, make a dough, make beads, make blocks .Routine Physical Therapy includes stretching spastic muscles, EMS, normalizing muscle tone.

Experimental group

Routine physical Therapy includes stretching spastic muscles, EMS, normalizing muscle tone.

control group

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Spastic CP children
  • Both male and female
  • Age 4-7 years
  • Actively grasp of objects from table i.e., stuff toys, making blocks
  • One to one attention

You may not qualify if:

  • Cognitive delays preventing the child from following two-step instructions
  • Health diagnoses unassociated with USCP.
  • Parents unable to commit to entire duration of intervention.
  • Visual difficulties preventing performance of intervention tasks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (4)

  • Oskoui M, Coutinho F, Dykeman J, Jette N, Pringsheim T. An update on the prevalence of cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2013 Jun;55(6):509-19. doi: 10.1111/dmcn.12080. Epub 2013 Jan 24.

    PMID: 23346889BACKGROUND
  • Tronnes H, Wilcox AJ, Lie RT, Markestad T, Moster D. Risk of cerebral palsy in relation to pregnancy disorders and preterm birth: a national cohort study. Dev Med Child Neurol. 2014 Aug;56(8):779-85. doi: 10.1111/dmcn.12430. Epub 2014 Mar 13.

    PMID: 24621110BACKGROUND
  • Patel DR, Neelakantan M, Pandher K, Merrick J. Cerebral palsy in children: a clinical overview. Transl Pediatr. 2020 Feb;9(Suppl 1):S125-S135. doi: 10.21037/tp.2020.01.01.

  • He P, Chen G, Wang Z, Guo C, Zheng X. Children with motor impairment related to cerebral palsy: Prevalence, severity and concurrent impairments in China. J Paediatr Child Health. 2017 May;53(5):480-484. doi: 10.1111/jpc.13444. Epub 2017 Jan 17.

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Fatima Ejaz, MS-PT

    University of Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Home Based Intensive Bimanual training
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 16, 2021

Study Start

March 6, 2020

Primary Completion

December 6, 2020

Study Completion

December 6, 2020

Last Updated

February 16, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Results of the study

Locations