NCT03521427

Brief Summary

The aim of the study is to determine the effetiveness of the intensive upper and lower limbs therapy to improve the funtional outcomes and to minimize ther energetic spendings during funtional activities in Cerebral Palsy patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

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

First Submitted

Initial submission to the registry

June 29, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

July 14, 2017

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

20 days

First QC Date

June 29, 2017

Last Update Submit

May 9, 2018

Conditions

Cerebral Palsy

Keywords

Intensive TherapyCerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • Arm Funtion

    Assissting Hand Assessment Instrument (AHA)

    6 months

Secondary Outcomes (2)

  • Funtional Activity

    6 months

  • Perception of performance in everyday living

    6 months

Study Arms (2)

Intensive bimanual therapy

EXPERIMENTAL

Ninety hours of intensive bimanual therapy

Other: Intensive bimanual therapy

Neurodevelopmental treatment

ACTIVE COMPARATOR

Ninety hours of intensive neurodevelopmental therapy

Other: Intensive neurodevelopmental therapy

Interventions

Intensive bimanual therapyOTHER

Ninety hours of intensive bimanual therapy

Intensive bimanual therapy
Intensive neurodevelopmental therapyOTHER

Ninety hours of intensive neurodevelopmental therapy

Neurodevelopmental treatment

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Cerebral Palsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University

Alcalá de Henares, Madrid, 28803, Spain

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Andrew Gordon, PhD

    Columbia Universuty

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 29, 2017

First Posted

May 11, 2018

Study Start

July 14, 2017

Primary Completion

August 3, 2017

Study Completion

February 3, 2018

Last Updated

May 11, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)