NCT02643160

Brief Summary

The purpose of this study is to analyze if trunk training has effects on trunk, upper, lower extremity motor functions in children with spastic Cerebral Palsy. Second purpose is to analyze the relation between trunk control and prematurity, birth weight, upper and lower extremity motor functions in children with spastic Cerebral Palsy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

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

January 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 31, 2015

Completed
Last Updated

December 31, 2015

Status Verified

December 1, 2015

Enrollment Period

1.7 years

First QC Date

November 25, 2015

Last Update Submit

December 30, 2015

Conditions

Keywords

Trunk TrainingMotor Function

Outcome Measures

Primary Outcomes (1)

  • Change in trunk control over time assessed with Trunk Control Measurement Scale.

    Assessing change in trunk control

    At baseline and 8 weeks after baseline

Secondary Outcomes (12)

  • Change in daily living activities and participation over time assessed with Child Health Questionary Parent Form 50.

    At baseline and 8 weeks after baseline

  • Change in muscle activation over time assessed with Surface Electromyography.

    At baseline and 8 weeks after baseline

  • Change in muscle spasticity over time assessed with Modified Tardieu Scale.

    At baseline and 8 weeks after baseline

  • Change in gross motor function over time assessed with Gross Motor Function Measurement

    At baseline and 8 weeks after baseline

  • Change in upper extremity skills over time assessed with Quality of Upper Extremity Skills Test

    At baseline and 8 weeks after baseline

  • +7 more secondary outcomes

Study Arms (2)

Functional Trunk Training Group

EXPERIMENTAL

Functional Trunk Training which includes strengthening of trunk muscle and functional activities including trunk region.

Other: Functional Trunk Training

Control Group

NO INTERVENTION

No intervention, the continued their regular physical therapy

Interventions

The intervention includes neurodevelopment treatment, muscle strengthening and functional activities of trunk region

Functional Trunk Training Group

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children with spastic cerebral palsy effected bilaterally
  • Between 4-18 years age

You may not qualify if:

  • Received orthopedic surgery during last 6 weeks
  • Receive Botulinum Toxin injection during last 6 weeks
  • Mentally retarded children with communication limitations
  • Had epileptic seizures during last 12 moths -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Heyrman L, Molenaers G, Desloovere K, Verheyden G, De Cat J, Monbaliu E, Feys H. A clinical tool to measure trunk control in children with cerebral palsy: the Trunk Control Measurement Scale. Res Dev Disabil. 2011 Nov-Dec;32(6):2624-35. doi: 10.1016/j.ridd.2011.06.012. Epub 2011 Jul 14.

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mintaze KEREM GÜNEL, Professor

    Hacettepe University, Graduate School of Health Sciences, Physical Therapy and Rehabilitation Department

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2015

First Posted

December 31, 2015

Study Start

January 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

December 31, 2015

Record last verified: 2015-12