Movement in the Non-use of the Affected Upper Extremity in Children Hemiparesis: Mirror Therapy and Action-observation

NCT ID: NCT04284176

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-20
• Study Completion Date: 2021-12-30

Brief Summary

Children with cerebral palsy hemiplegia present a restriction in the daily activities due to the limitation in the active movement of the affected upper extremity.

The mirror therapy (MT) in children with hemiparesis produces an improvement in the quality of movement and in the perception of the affected upper extremity. The action-observation therapy (AOT) favors the motor behaviour of the affected upper extremity through the observation of sequences of systematic activities and their posterior execution. It also produces an increase in the excitability of the corticospinal tract, originating muscular pattern contraction similar to the observed ones and favoring the motor activity.

The combination of both therapies might improve the quality of movement of the upper extremity and provide a major cortical activation and increase the spontaneous use on having created the only protocol of intervention which includes the benefits of both interventions.

The principal aim of this study is to analyze the influence of the quality of movement in the spontaneous use of the upper extremity affected in children with hemiparesis as well as the improvement of both variables across MTAO. Another specific aim will be to determine if "the non-use" is determined by the quality of the movement of the segment, if the MTAO reduces "the non-use" of this extremity as well as to obtain a protocol of intervention that increases the quality of movement and the spontaneous long-term use.

A randomized controlled trial will be carry out in children with hemiparesia between 6 and 12 years, with a spontaneous use of the hand according to the scale HOUSE, a level Manual Ability Classification System (MASC) I-III and a good cooperation and cognition. Those with a severe spasticity, previous surgery of the upper extremity and the use of botox will be excluded. The children will be divided in two groups. The experimental group will receive for 20 days a daily therapy of 15 minutes at home of MT and 45 of AOT, whereas the control group will receive 60 minutes of AOT.

Four measurements will be obtained: basal situation, at the end of the treatment and measures of follow-up to 3 and 6 months after the end of the treatment. Despite the sociodemographic variables, measures of the quality of the movement, the spontaneous use of the upper extremity, the questionnaire CHEQ and the AHA scale.

Detailed Description

Two protocols are designed to be carried out at home. The AOT protocol includes 15 set of daily life upper limb uni/bimanual activities (8 sets for bimanual activities and 7 sets for unimanual activities).

The MTAO group include 6 mirror therapy activities and the same activities that are included in the AOT protocol.

A pilot study will be conducted for sample size calculation, assessing the AHA and Jebsen-Taylor scales, before and immediately after the intervention.

Conditions

Hemiplegia, Infantile

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mirrow therapy and action-observation therapy

The intervention include 20 hours, applied during a four-week period (1 hour per day from Monday to Friday) at home. The first 15 minutes will include myrror therapy 6 activities and the remaing 45 minutes both unimanual and bimanual action-observation therapy activities.

Group Type: EXPERIMENTAL

Mirror therapy and action-observation therapy

Intervention Type: OTHER

The mirror therapy and action-observation therapy group will receive for 20 days a daily therapy of 15 minutes at home of MT and 45 of AOT, whereas the action-observation therapy group will receive 60 minutes of AOT.

Action-observation therapy

The intervention include 20 hours, applied during a four-week period (1 hour per day from Monday to Friday) at home. There protocol includes both unimanual and bimanual action-observation therapy activities.

Group Type: EXPERIMENTAL

Mirror therapy and action-observation therapy

Intervention Type: OTHER

The mirror therapy and action-observation therapy group will receive for 20 days a daily therapy of 15 minutes at home of MT and 45 of AOT, whereas the action-observation therapy group will receive 60 minutes of AOT.

Interventions

Mirror therapy and action-observation therapy

The mirror therapy and action-observation therapy group will receive for 20 days a daily therapy of 15 minutes at home of MT and 45 of AOT, whereas the action-observation therapy group will receive 60 minutes of AOT.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Children with hemiparesia.
• From 6 to 12 years,
• A spontaneous use of the hand according to the scale HOUSE, a level MACS I-III
• A good cooperation and cognition

Exclusion Criteria

• Severe spasticity
• Previous surgery of the upper extremity
• The use of botox

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CEU San Pablo University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan-Carlos Zuil-Escobar, PhD

Role: PRINCIPAL_INVESTIGATOR

CEU San Pablo University

Locations

CEU-San Pablo Universtiy

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Juan-Carlos Zuil-Escobar, PhD

Role: CONTACT

jczuil@ceu.es

+34616442143

Facility Contacts

Juan Carlos Zuil-Escobar, PhD

Role: primary

jczuil@ceu.es

913724700

Other Identifiers

CEUSPU

Identifier Type: -

Identifier Source: org_study_id