Effects of Intensive Upper and Lower Limbs Motor Control... | NCT03521427

Studies
Effects of Intensive Upper and Lower Limbs Motor Control Therapy in Cerebral Palsy Children

NCT03521427

Sponsor

University of Alcala

Status

Completed

Last Update Posted

May 11, 2018Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Cerebral Palsy

Interventions

Intensive bimanual therapy
Intensive neurodevelopmental therapy

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 14, 2017Actual

Primary Completion Date

Aug 3, 2017Actual

Completion Date

Feb 3, 2018Actual

First Submitted Date

Jun 29, 2017

First Submission Date that Met QC Criteria

May 9, 2018

First Posted Date

May 11, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2018

Last Update Posted Date

May 11, 2018Actual

Name	Class
European University Spain	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Intensive bimanual therapy	Other	Ninety hours of intensive bimanual therapy	Intensive bimanual therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Arm Funtion	Assissting Hand Assessment Instrument (AHA)	6 months

Secondary Outcomes

Measure	Description	Time Frame
Funtional Activity	Jebsen Taylor Hand Funtion Test	6 months
Perception of performance in everyday living	Canadian Occupational Performance Measure (COMP)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cerebral Palsy

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew Gordon, PhD	Columbia Universuty	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University		Alcalá de Henares	Madrid	28803	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided