NCT03465046

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

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

March 1, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

1 month

First QC Date

March 1, 2018

Last Update Submit

November 2, 2020

Conditions

Infantile Hemiplegia

Keywords

infantile hemiplegiaupper extremityphysical therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 assessments will be carried out in the research in 10 weeks

Secondary Outcomes (1)

  • quality of life ,"change" is being assessed

    4 assessments will be carried out in the research in 10 weeks

Study Arms (4)

low performance group 1

EXPERIMENTAL

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

Combination Product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2

low performance group 2

EXPERIMENTAL

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

Combination Product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2

moderate-high performance group1

EXPERIMENTAL

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

Combination Product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2

moderate-high performance group 2

EXPERIMENTAL

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

Combination Product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2

Interventions

intensive therapies(CIMT/BIT): protocol 1 or protocol 2COMBINATION_PRODUCT

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

low performance group 1low performance group 2moderate-high performance group 2moderate-high performance group1

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rocío Palomo Carrión

Torrijos, Toledo, 45500, Spain

Location

Related Publications (8)

  • 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.

    PMID: 29050511RESULT

  • 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.

    PMID: 28953170RESULT

  • 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.

    PMID: 27022371RESULT

  • 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.

    PMID: 26164301RESULT

  • 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.

    PMID: 24983295RESULT

  • 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.

    PMID: 24820334RESULT

  • Palomo-Carrion R, Ferri-Morales A, Ando-LaFuente S, Fernandez RA, Arenillas JIC, Anton-Anton V, Esteban EB. Constraint-induced movement therapy versus bimanual intensive therapy in children with hemiplegia showing low/very low bimanual functional performance: A randomized clinical trial. PM R. 2023 Dec;15(12):1536-1546. doi: 10.1002/pmrj.12990. Epub 2023 Jun 19.

    PMID: 37139775DERIVED

  • 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.

    PMID: 34408823DERIVED

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rocío Palomo Carrión

    Salamanca University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 1, 2018

First Posted

March 14, 2018

Study Start

October 15, 2018

Primary Completion

November 25, 2018

Study Completion

January 30, 2019

Last Updated

November 4, 2020

Record last verified: 2020-11

Locations

ES(1)