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

Hemiplegic Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05244083
• Other study ID #: FIS-2021-07
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Universitat Internacional de Catalunya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 22
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegic Cerebral Palsy
• Muscle Spasticity
• Paralysis

Intervention

Other:
• 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.
• Program without Mirror Therapy
Bimanual exercises performed with both upper limbs.

Locations

Country	Name	City	State
Spain	Fundació Aspace Catalunya	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Tactile Registration of the impaired hand.	An evaluation to determine whether the impaired hand is capable of identifying a somatosensory stimuli. The index pad is stimulated with the Semmes Weinstein Monofilament, starting with the largest monofilament considered as "normal sensation. 3 correct identifications are considered as a correct answer, with the smallest monofilament possible.	Baseline, at 5 weeks and at 9 weeks
Secondary	Change in static two-point discrimination of the impaired hand.	An evaluation to determine the shortest distance that the impaired hand is capable of identifying to simultaneous stimuli.The index pad is stimulated with the Disk-Criminator, that applies two simultaneous stimuly. The shortest distance at which the patient is capable of idenitfying both stimuli 7/10 times is considered as a correct answer.	Baseline, at 5 weeks and at 9 weeks
Secondary	Change in moving two-point discrimination of the impaired hand.	An evaluation to determine the shortest distance that the impaired hand is capable of identifying to moving simultaneous stimuli.The index pad is stimulated with the Disk-Criminator, that applies two simultaneous stimuly, with small circular movement. The shortest distance at which the patient is capable of idenitfying both stimuli 7/10 times is considered as a correct answer.	Baseline, at 5 weeks and at 9 weeks
Secondary	Change in single point localisation of the impaired hand.	An evaluation to determine both the capacity of the patient to identify a threshold stimuly applied to thumb, index, 4th and 5th finger of the impaired hand, and the position where stimuli is applied (front, back or side). 12 different stimulations are applied, and the correct answers are the final punctuation.	Baseline, at 5 weeks and at 9 weeks
Secondary	Change in double simultaneous of the impaired hand.	An evaluation to determine the capacity of the patient to identify a threshold stimuly applied to thumb, index, 4th and 5th finger of the impaired hand, and on the same fingers of the other hand, single and combined. 24 different stimulations are applied, and the correct answers are the final punctuation.	Baseline, at 5 weeks and at 9 weeks
Secondary	Change in sterognosis of the impaired hand.	An evaluation to determine the capacity of the patient to identify 9 different objects (pen, pencil, button, coin, safety pin, paper clip, key, peg and spoon) placed on the impaired hand, without visual feedback. The final punctuation is for the correct identifications.	Baseline, at 5 weeks and at 9 weeks
Secondary	Self-reported Quality of Life	How the self-perceived quality of life, assessed with Pediatric Quality of Life Inventory (PEDSQL - CP Module), changes by performing the intervention. The evaluation consists of gradinf (from 0 - never; to 4 - always), how have different situations caused trouble or impairment to children. The presented situations are related to daily activities, movement, pain, school activities, comunication, feeding and fatigue.	Baseline, at 5 weeks and at 9 weeks