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Intensive Therapies in Children With Hemiplegia (CIMT/BIT)

Primary Purpose

Infantile Hemiplegia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
intensive therapies(CIMT/BIT): protocol 1 or protocol 2
Sponsored by
University of Salamanca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infantile Hemiplegia focused on measuring infantile hemiplegia, upper extremity, physical therapy

Eligibility Criteria

5 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children diagnosed with Unilateral Infantile Cerebral Palsy, Congenital Infantile Hemiparesis.
  • Ages between 5 to 10 years.
  • Levels of I-III within the , manual ability classification system, MACS.
  • Levels of I-III within the gross motor function classification system, GMFCS

Exclusion Criteria:

- Diseases not associated with infantile hemiparesis.

  • Low cognitive level to understand the execution of activities.
  • Surgeries of the upper extremity during the 6 months prior to the intervention.
  • Structured contractures in the affected upper extremity that cause functional impotence.
  • Botulinum toxin two months prior to the intervention and application of it during the treatment.
  • Epilepsy not controlled pharmacologically

Sites / Locations

  • Rocío Palomo Carrión

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

low performance group 1

low performance group 2

moderate-high performance group1

moderate-high performance group 2

Arm Description

Protocol 1 will be the intervention administered with 80 h modified constraint induced movement therapy and 20 h bimanual intensive therapy

Protocol 2 will be the intervention administered with 80h bimanual intensive therapy and 20h modified constraint induced movement therapy

Protocol 1 will be the intervention administered with 80 h modified constraint induced movement therapy and 20 h bimanual intensive therapy

Protocol 2 will be the intervention administered with 80h bimanual intensive therapy and 20h modified constraint induced movement therapy

Outcomes

Primary Outcome Measures

bimanual functional performance, "change" is being assessed
use of the affected upper extremity of spontaneous character during bimanual activities. It is used the AHA assessment to measure it.

Secondary Outcome Measures

quality of life ,"change" is being assessed
This measure will be assessed with the pedsQL questionnaire

Full Information

First Posted
March 1, 2018
Last Updated
November 2, 2020
Sponsor
University of Salamanca
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1. Study Identification

Unique Protocol Identification Number
NCT03465046
Brief Title
Intensive Therapies in Children With Hemiplegia
Acronym
CIMT/BIT
Official Title
Modified Constraint Induced Movement Therapy and Bimanual Intensive Therapy in Children With Hemiplegia. Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
November 25, 2018 (Actual)
Study Completion Date
January 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a comparative study where two protocols of intensive therapies will be applied to study the improvements in the functional performance of the affected upper limb of children with hemiparesis and check whether to increase their quality of life.
Detailed Description
the intervention protocols combine different doses of intensive therapy, being 80 hours of modified constraint induced movement therapy followed by 20 hours for protocol 1 and protocol 2 would be the application of protocol 1 inverted, with this, the investigators want to compare how both protocols interfere in the function of the affected upper limb of children with different levels of bimanual functional performance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Hemiplegia
Keywords
infantile hemiplegia, upper extremity, physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low performance group 1
Arm Type
Experimental
Arm Description
Protocol 1 will be the intervention administered with 80 h modified constraint induced movement therapy and 20 h bimanual intensive therapy
Arm Title
low performance group 2
Arm Type
Experimental
Arm Description
Protocol 2 will be the intervention administered with 80h bimanual intensive therapy and 20h modified constraint induced movement therapy
Arm Title
moderate-high performance group1
Arm Type
Experimental
Arm Description
Protocol 1 will be the intervention administered with 80 h modified constraint induced movement therapy and 20 h bimanual intensive therapy
Arm Title
moderate-high performance group 2
Arm Type
Experimental
Arm Description
Protocol 2 will be the intervention administered with 80h bimanual intensive therapy and 20h modified constraint induced movement therapy
Intervention Type
Combination Product
Intervention Name(s)
intensive therapies(CIMT/BIT): protocol 1 or protocol 2
Intervention Description
The therapies applied in both protocols are intensive therapies that allow the execution of unimanual activities or bimanual activities with the affected upper limb with different doses. the protocols were carried out at home through the family
Primary Outcome Measure Information:
Title
bimanual functional performance, "change" is being assessed
Description
use of the affected upper extremity of spontaneous character during bimanual activities. It is used the AHA assessment to measure it.
Time Frame
4 assessments will be carried out in the research in 10 weeks
Secondary Outcome Measure Information:
Title
quality of life ,"change" is being assessed
Description
This measure will be assessed with the pedsQL questionnaire
Time Frame
4 assessments will be carried out in the research in 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children diagnosed with Unilateral Infantile Cerebral Palsy, Congenital Infantile Hemiparesis. Ages between 5 to 10 years. Levels of I-III within the , manual ability classification system, MACS. Levels of I-III within the gross motor function classification system, GMFCS Exclusion Criteria: - Diseases not associated with infantile hemiparesis. Low cognitive level to understand the execution of activities. Surgeries of the upper extremity during the 6 months prior to the intervention. Structured contractures in the affected upper extremity that cause functional impotence. Botulinum toxin two months prior to the intervention and application of it during the treatment. Epilepsy not controlled pharmacologically
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rocío Palomo Carrión
Organizational Affiliation
Salamanca University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rocío Palomo Carrión
City
Torrijos
State/Province
Toledo
ZIP/Postal Code
45500
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29050511
Citation
Tervahauta MH, Girolami GL, Oberg GK. Efficacy of constraint-induced movement therapy compared with bimanual intensive training in children with unilateral cerebral palsy: a systematic review. Clin Rehabil. 2017 Nov;31(11):1445-1456. doi: 10.1177/0269215517698834. Epub 2017 Mar 20.
Results Reference
result
PubMed Identifier
28953170
Citation
Klepper SE, Clayton Krasinski D, Gilb MC, Khalil N. Comparing Unimanual and Bimanual Training in Upper Extremity Function in Children With Unilateral Cerebral Palsy. Pediatr Phys Ther. 2017 Oct;29(4):288-306. doi: 10.1097/PEP.0000000000000438.
Results Reference
result
PubMed Identifier
27022371
Citation
Zafer H, Amjad I, Malik AN, Shaukat E. Effectiveness of Constraint induced movement therapy as compared to bimanual therapy in Upper motor function outcome in child with hemiplegic Cerebral palsy. Pak J Med Sci. 2016 Jan-Feb;32(1):181-4. doi: 10.12669/pjms.321.8491.
Results Reference
result
PubMed Identifier
26164301
Citation
Geerdink Y, Aarts P, van der Burg J, Steenbergen B, Geurts A. Intensive upper limb intervention with self-management training is feasible and promising for older children and adolescents with unilateral cerebral palsy. Res Dev Disabil. 2015 Aug-Sep;43-44:97-105. doi: 10.1016/j.ridd.2015.06.013. Epub 2015 Jul 9.
Results Reference
result
PubMed Identifier
24983295
Citation
Gelkop N, Burshtein DG, Lahav A, Brezner A, Al-Oraibi S, Ferre CL, Gordon AM. Efficacy of constraint-induced movement therapy and bimanual training in children with hemiplegic cerebral palsy in an educational setting. Phys Occup Ther Pediatr. 2015 Feb;35(1):24-39. doi: 10.3109/01942638.2014.925027. Epub 2014 Jul 1.
Results Reference
result
PubMed Identifier
24820334
Citation
Sakzewski L, Gordon A, Eliasson AC. The state of the evidence for intensive upper limb therapy approaches for children with unilateral cerebral palsy. J Child Neurol. 2014 Aug;29(8):1077-90. doi: 10.1177/0883073814533150. Epub 2014 May 11.
Results Reference
result
PubMed Identifier
34408823
Citation
Palomo-Carrion R, Lirio-Romero C, Ferri-Morales A, Jovellar-Isiegas P, Cortes-Vega MD, Romay-Barrero H. Combined intensive therapies at home in spastic unilateral cerebral palsy with high bimanual functional performance. What do they offer? A comparative randomised clinical trial. Ther Adv Chronic Dis. 2021 Aug 12;12:20406223211034996. doi: 10.1177/20406223211034996. eCollection 2021.
Results Reference
derived

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Intensive Therapies in Children With Hemiplegia

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