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

NCT05244083 | Unknown

• 1 other identifier: FIS-2021-07
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Keywords

unilateral spastic cerebral palsy; mirror therapy; bimanual performance; somatosensory function; quality of life

Outcome Measures

Primary Outcomes (1)

• Change in Bimanual Performance

  How Bimanual Performance, assessed with Children's Hand-use Experience Questionnaire, changes by doing the intervention

  Baseline, at 5 weeks and at 9 weeks

Secondary Outcomes (7)

• Change in Tactile Registration of the impaired hand.

  Baseline, at 5 weeks and at 9 weeks

• Change in static two-point discrimination of the impaired hand.

  Baseline, at 5 weeks and at 9 weeks

• Change in moving two-point discrimination of the impaired hand.

  Baseline, at 5 weeks and at 9 weeks

• Change in single point localisation of the impaired hand.

  Baseline, at 5 weeks and at 9 weeks

• Change in double simultaneous of the impaired hand.

  Baseline, at 5 weeks and at 9 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Other: Mirror Therapy

Control Group

ACTIVE COMPARATOR

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.

Other: Program without Mirror Therapy

Interventions

Mirror Therapy 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.

Experimental Group

Program without Mirror Therapy OTHER

Bimanual exercises performed with both upper limbs.

Control Group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Fundació Aspace Catalunya

Barcelona, 08038, Spain

Location

MeSH Terms

Interventions

Mirror Movement Therapy

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• MARIA CARITAT BAGUR CALAFAT, PHD

  Universitat Internacional de Catalunya

  STUDY DIRECTOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: February 17, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)