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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

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

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

NCT ID

NCT03465046

First Posted

March 1, 2018

Last Updated

November 2, 2020

Sponsor

University of Salamanca

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

Studies a U.S. FDA-regulated Device Product

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

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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