Clinical trial NCT04284176: Movement in the Non-use of the Affected Upper Extremity in Children Hemiparesis: Mirror Therapy and Action-observation
Official title: Influence of the Quality of Movement in the "Non-use" of the Upper Extremity Affected in Children Hemiparesis: Mirror Therapy and Action-observation as Therapeutic Strategies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemiplegia, Infantile
Lead sponsor: CEU San Pablo University
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Effectiveness of the affected hand and arm in bimanual performance assess by Assisting Hand Assessment (AHA) scale
timeFrame: 6 months
measure: Functionality of the affected hand assess by Jensen-Taylor scale
timeFrame: 6 months
measure: Experience of children in the use of the affected hand during activities where two hands are usually required assess by the Children's Hand-use Experience Questionnaire (CHEQ).
timeFrame: 6 months
measure: Grip strength assess by hand grip dynamometer
timeFrame: 6 months
measure: Muscular activity of the wrist muscles assess by Surface electromyography (EMG)
timeFrame: 6 months
measure: Range of motion of the wrist assess by goniometer and goniometer app
timeFrame: 6 months
Secondary outcomes:
measure: correlation between range of motion of the wrist assessed by goniometer and goniometer app
timeFrame: 1 day
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CEU-San Pablo Universtiy
Study officials:
affiliation: CEU San Pablo University
name: Juan-Carlos Zuil-Escobar, PhD
role: PRINCIPAL_INVESTIGATOR
References: