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

NCT04284176 | Unknown

• 1 other identifier: CEUSPU
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegia, Infantile

Outcome Measures

Primary Outcomes (6)

• Effectiveness of the affected hand and arm in bimanual performance assess by Assisting Hand Assessment (AHA) scale

  AHA scale includes several domains: general use, arm use, grasp-release, fine motor adjustments, coordination and rhythm. 22 items are scored and converted to 0-100 logit-based AHA units.

  6 months

• Functionality of the affected hand assess by Jensen-Taylor scale

  The Jebsen-Taylor scale includes 7 subtests: writing, card turning, picking up small objects, stacking checkers, stimulated feeding, moving lights objects, moving heavy objects. Normative data are described for adults, but not for children.

  6 months

• 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).

  The CHEQ questionnaire ask about some activities that typically require the use of both hands. The results are converted into logits using Rasch analysis.

  6 months

• Grip strength assess by hand grip dynamometer

  Hand grip dynamometer

  6 months

• Muscular activity of the wrist muscles assess by Surface electromyography (EMG)

  Surface EMG

  6 months

• Range of motion of the wrist assess by goniometer and goniometer app

  Goniometer and goniometer app

  6 months

Secondary Outcomes (1)

• correlation between range of motion of the wrist assessed by goniometer and goniometer app

  1 day

Study Arms (2)

Mirrow therapy and action-observation therapy

EXPERIMENTAL

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.

Other: Mirror therapy and action-observation therapy

Action-observation therapy

EXPERIMENTAL

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.

Other: Mirror therapy and action-observation therapy

Interventions

Mirror therapy and action-observation therapy 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; Mirrow therapy and action-observation therapy

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• CEU San Pablo University: lead

Study Sites (1)

CEU-San Pablo Universtiy

Madrid, 28922, Spain

RECRUITING

MeSH Terms

Conditions

Hemiplegia

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Juan-Carlos Zuil-Escobar, PhD

  CEU San Pablo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan-Carlos Zuil-Escobar, PhD

CONTACT

+34616442143; jczuil@ceu.es

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: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 25, 2020
• Study Start: September 20, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)