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Effectiveness of Routine Physical Therapy With Intensive Bimanual Training in Cerebral Palsy Children

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
home based intensive bimanual training
Routine Physical Therapy
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, Bimanual Training

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of lahore

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Experimental group

control group

Arm Description

Intensive bimanual training with routine physical therapy

routine physical therapy

Outcomes

Primary Outcome Measures

ABILHAND
hand coordination

Secondary Outcome Measures

Pediatric Motor Log Activity Scale
Activity of Daily Living

Full Information

First Posted
February 10, 2021
Last Updated
February 10, 2021
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT04755556
Brief Title
Effectiveness of Routine Physical Therapy With Intensive Bimanual Training in Cerebral Palsy Children
Official Title
Effectiveness of Routine Physical Therapy With or Without Home Based Intensive Bimanual Training on Clinical Outcomes in Cerebral Palsy Children: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 6, 2020 (Actual)
Primary Completion Date
December 6, 2020 (Actual)
Study Completion Date
December 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Effectiveness of Routine Physical Therapy With or Without Home Based Intensive Bimanual Training on Clinical Outcomes in Cerebral Palsy Children
Detailed Description
Cerebral Palsy is one of the most common issue seen in pediatric rehabilitation .Home based intensive Bimanual training has proven to be one of the most effective rehabilitation training for improving motor. The study determines the effectiveness of routine physical therapy with or without home-based intensive bimanual training on coordination of hands and daily activities of daily living. A nine months randomized control trial was comprised of thirty children with unilateral spastic cerebral palsy aged between 4 to 7 years. One group received routine physical therapy and the other group received a goal specific bimanual training from their parents in their home setting for 3.5 hours per week for 6 weeks according to a modified set up. Follow up sessions were done at 6th week. Activities of daily living and coordination were measured using Pediatric motor log activity scale and ABILHAND respectively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral Palsy, Bimanual Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Home Based Intensive Bimanual training
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Other
Arm Description
Intensive bimanual training with routine physical therapy
Arm Title
control group
Arm Type
Other
Arm Description
routine physical therapy
Intervention Type
Other
Intervention Name(s)
home based intensive bimanual training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Routine Physical Therapy
Intervention Description
Routine physical Therapy includes stretching spastic muscles, EMS, normalizing muscle tone.
Primary Outcome Measure Information:
Title
ABILHAND
Description
hand coordination
Time Frame
6th week
Secondary Outcome Measure Information:
Title
Pediatric Motor Log Activity Scale
Description
Activity of Daily Living
Time Frame
6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatima Ejaz, MS-PT
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results of the study
Citations:
PubMed Identifier
23346889
Citation
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. Erratum In: Dev Med Child Neurol. 2016 Mar;58(3):316.
Results Reference
background
PubMed Identifier
24621110
Citation
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.
Results Reference
background
PubMed Identifier
32206590
Citation
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.
Results Reference
result
PubMed Identifier
28094881
Citation
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.
Results Reference
result

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Effectiveness of Routine Physical Therapy With Intensive Bimanual Training in Cerebral Palsy Children

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