Effectiveness of the Mirror Therapy for Improving Bimanual Performance, Somatosensory Function of the Impaired Upper Limb and Quality of Life in Children With Unilateral Spastic Cerebral Palsy

NCT ID: NCT05244083

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-12-31

Brief Summary

• Background: Unilateral Spastic Cerebral Palsy (USPC) is caused by an injury in one brain hemisphere in the immature brain, and affects the contralateral side of the body, especially on the upper limb. It induces motor and somatosensory damages, that are closely related to the hand function. Evidence posits mirror therapy to be a therapy with potential effects on bimanual performance and somatosensory function, that may influence on quality of life. The aim of this study is to demonstrate the effectiveness of a motor program with mirror therapy in children with USCP in the improvement of the bimanual performance, the somatosensory function and quality of life compared with the same program without mirror.
• Methods: This study is a Randomised Clinical Trial. The participants are children with USCP aged between 8 and 12 years old classified in levels I and II in Manual Ability Classification System, recruited from Fundació Aspace Catalunya. The eligibility criteria are a) to not have had surgical interventions, botulinum toxin or shock waves 3 months before the study; b) to not be receiving intensive therapies on the upper limb; c) to not have attentional or behavioural difficulties; d) to not have moderate to high intellectual disability; e) to not have non-treated epilepsy; and f) to not have non-corrected visual problems. A total of 22 participants will be recruited for this study, and will be randomised in two groups: control and experimental, through the opaque envelope technique. The experimental group will perform a 5-week motor program consisting of 4 bimanual exercises with mirror therapy, to be done at home 30 minutes a day, 5 days a week, while the control group will perform the same program without the mirror. The assessments will be done by a blinded evaluator and will include bimanual performance (Children's Hand-use Experience Questionnaire), somatosensory function and quality of life (PedsQL™), and will be performed at the beginning, at the end of the intervention and 1-month follow-up.
• Discussion: Favourably results in this study may imply the implementation of a low-cost therapy, suitable to be done at home, and with no contraindications for children with USCP. Moreover, the suitability to be adapted and performed at home could increase the family implication and empowerment, increasing its confidence in the disability process.

Conditions

Hemiplegic Cerebral Palsy; Mirror Movement Therapy

Study Design

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

Study Groups

Experimental Group

The experimental group will perform a 5-week motor program consisting of 4 bimanual exercises with mirror therapy, to be done at home 30 minutes a day, 5 days a week.

Group Type: EXPERIMENTAL

Mirror Therapy

Intervention Type: OTHER

Therapy consisting of perfoming bimanual activities with a mirror placed on the patient's sagital plane, so it creates the brain illusion that the impaired limb moves the same way and quality that the unimpaired does.

Control Group

The control group will perform a 5-week motor program consisting of 4 bimanual exercises without mirror therapy, to be done at home 30 minutes a day, 5 days a week.

Group Type: ACTIVE_COMPARATOR

Program without Mirror Therapy

Intervention Type: OTHER

Bimanual exercises performed with both upper limbs.

Interventions

Mirror Therapy

Therapy consisting of perfoming bimanual activities with a mirror placed on the patient's sagital plane, so it creates the brain illusion that the impaired limb moves the same way and quality that the unimpaired does.

Intervention Type: OTHER

Program without Mirror Therapy

Bimanual exercises performed with both upper limbs.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• To have been diagnosed with Unilateral Spastic Cerebral Palsy.
• To be capable of following and understanding rules.

Exclusion Criteria

• To have had surgical interventions, botulinum toxin or shock waves 3 months before the study;
• To be receiving intensive therapies on the upper limb;
• To have attentional or behavioural difficulties;
• To have moderate to high intellectual disability;
• To have non-treated epilepsy;
• To have non-corrected visual problems

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitat Internacional de Catalunya

OTHER

Sponsor Role: lead

Responsible Party

Anna Ortega I Martínez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MARIA CARITAT BAGUR CALAFAT, PHD

Role: STUDY_DIRECTOR

Universitat Internacional de Catalunya

Locations

Fundació Aspace Catalunya

Barcelona, , Spain

Countries

Spain

Other Identifiers

FIS-2021-07

Identifier Type: -

Identifier Source: org_study_id