Back to resultsEffects of Intensive Upper and Lower Limbs Motor Control Therapy in Cerebral Palsy Children
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Intensive bimanual therapy
Intensive neurodevelopmental therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Intensive Therapy, Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- Cerebral Palsy
Exclusion Criteria:
-
Sites / Locations
- University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intensive bimanual therapy
Neurodevelopmental treatment
Arm Description
Ninety hours of intensive bimanual therapy
Ninety hours of intensive neurodevelopmental therapy
Outcomes
Primary Outcome Measures
Arm Funtion
Assissting Hand Assessment Instrument (AHA)
Secondary Outcome Measures
Funtional Activity
Jebsen Taylor Hand Funtion Test
Perception of performance in everyday living
Canadian Occupational Performance Measure (COMP)
Full Information
NCT ID
NCT03521427
First Posted
June 29, 2017
Last Updated
May 9, 2018
Sponsor
University of Alcala
Collaborators
European University Spain
1. Study Identification
Unique Protocol Identification Number
NCT03521427
Brief Title
Effects of Intensive Upper and Lower Limbs Motor Control Therapy in Cerebral Palsy Children
Official Title
Effects of Intensive Upper and Lower Limbs Motor Control Therapy in Cerebral Palsy Children
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 14, 2017 (Actual)
Primary Completion Date
August 3, 2017 (Actual)
Study Completion Date
February 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala
Collaborators
European University Spain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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. Also to know paretns and caregivers perceptions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Intensive Therapy, Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intensive bimanual therapy
Arm Type
Experimental
Arm Description
Ninety hours of intensive bimanual therapy
Arm Title
Neurodevelopmental treatment
Arm Type
Active Comparator
Arm Description
Ninety hours of intensive neurodevelopmental therapy
Intervention Type
Other
Intervention Name(s)
Intensive bimanual therapy
Intervention Description
Ninety hours of intensive bimanual therapy
Intervention Type
Other
Intervention Name(s)
Intensive neurodevelopmental therapy
Intervention Description
Ninety hours of intensive neurodevelopmental therapy
Primary Outcome Measure Information:
Title
Arm Funtion
Description
Assissting Hand Assessment Instrument (AHA)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Funtional Activity
Description
Jebsen Taylor Hand Funtion Test
Time Frame
6 months
Title
Perception of performance in everyday living
Description
Canadian Occupational Performance Measure (COMP)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cerebral Palsy
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Gordon, PhD
Organizational Affiliation
Columbia Universuty
Official's Role
Study Director
Facility Information:
Facility Name
University
City
Alcalá de Henares
State/Province
Madrid
ZIP/Postal Code
28803
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Intensive Upper and Lower Limbs Motor Control Therapy in Cerebral Palsy Children
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