NCT05244083

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

Status unknown NA Last updated 23 May 2023

What this trial tests

NA trial testing Mirror Therapy in Hemiplegic Cerebral Palsy in 22 participants. Status unknown.

Timeline

1 January 2022

Primary endpoint
31 December 2024

31 December 2024

Quick facts

Lead sponsor	Universitat Internacional de Catalunya
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	22
Start date	1 January 2022
Primary completion	31 December 2024
Estimated completion	31 December 2024
Sites	1 location across Spain

Drugs / interventions tested

• Mirror Therapy
• Program without Mirror Therapy

Conditions studied

• Hemiplegic Cerebral Palsy — all drugs for Hemiplegic Cerebral Palsy →
• Mirror Movement Therapy — all drugs for Mirror Movement Therapy →

Sponsor

Universitat Internacional de Catalunya — full company profile →

Who can join

Adults 8 to 12, any sex, with Hemiplegic Cerebral Palsy or Mirror Movement Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

* 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Feasibility of a Home-Based Mirror Therapy Program in Children with Unilateral Spastic Cerebral Palsy.
   Ortega-Martínez A, Palomo-Carrión R, Varela-Ferro C, Bagur-Calafat MC. · · 2023 · cited 2× · PMID 37372915 · DOI 10.3390/healthcare11121797