Clinical trial 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
Official title: 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: A Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Mirror Movement Therapy
Keywords: unilateral spastic cerebral palsy
mirror therapy
bimanual performance
somatosensory function
quality of life
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 22
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Bimanual Performance
timeFrame: Baseline, at 5 weeks and at 9 weeks
Secondary outcomes:
measure: Change in Tactile Registration of the impaired hand.
timeFrame: Baseline, at 5 weeks and at 9 weeks
measure: Change in static two-point discrimination of the impaired hand.
timeFrame: Baseline, at 5 weeks and at 9 weeks
measure: Change in moving two-point discrimination of the impaired hand.
timeFrame: Baseline, at 5 weeks and at 9 weeks
measure: Change in single point localisation of the impaired hand.
timeFrame: Baseline, at 5 weeks and at 9 weeks
measure: Change in double simultaneous of the impaired hand.
timeFrame: Baseline, at 5 weeks and at 9 weeks
measure: Change in sterognosis of the impaired hand.
timeFrame: Baseline, at 5 weeks and at 9 weeks
measure: Self-reported Quality of Life
timeFrame: Baseline, at 5 weeks and at 9 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fundació Aspace Catalunya
Study officials:
affiliation: Universitat Internacional de Catalunya
name: MARIA CARITAT BAGUR CALAFAT, PHD
role: STUDY_DIRECTOR
References: