Hemiplegic Cerebral PalsyNCT05244083
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 study testing Mirror Therapy and Program without Mirror Therapy in people with Hemiplegic Cerebral Palsy and Mirror Movement Therapy, run by Universitat Internacional de Catalunya at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy, Mirror Movement Therapy
- What is being tested?
- Mirror Therapy and Program without Mirror Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- To have been diagnosed with Unilateral Spastic Cerebral Palsy.
- To be capable of following and understanding rules.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- 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
- Being tested
- Mirror Therapy, Program without Mirror Therapy
- Keywords
- unilateral spastic cerebral palsy, mirror therapy, bimanual performance, somatosensory function, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror TherapyOther
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 TherapyOther
Bimanual exercises performed with both upper limbs.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Program without Mirror Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bimanual Performance
How Bimanual Performance, assessed with Children's Hand-use Experience Questionnaire, changes by doing the intervention
Measured: Baseline, at 5 weeks and at 9 weeks
Secondary outcomes (7)
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.
Measured: Baseline, at 5 weeks and at 9 weeks
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.
Measured: Baseline, at 5 weeks and at 9 weeks
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.
Measured: Baseline, at 5 weeks and at 9 weeks
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.
Measured: Baseline, at 5 weeks and at 9 weeks
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.
Measured: Baseline, at 5 weeks and at 9 weeks
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.
Measured: Baseline, at 5 weeks and at 9 weeks
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.
Measured: Baseline, at 5 weeks and at 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Ortega I Martínez, Universitat Internacional de Catalunya
- Investigators
- MARIA CARITAT BAGUR CALAFAT, PHD, Study director, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244083
- Sponsor's protocol ID
- FIS-2021-07
- Status last verified
- May 2023
- First submitted
- 7 Jan 2022
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05244083
- Acronym / sponsor ID
- FIS-2021-07
- Conditions
- Hemiplegic Cerebral Palsy, Mirror Movement Therapy
- Keywords
- unilateral spastic cerebral palsy, mirror therapy, bimanual performance, somatosensory function, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Mirror TherapyThe 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. |
| Control Group | Active comparator | Other: Program without Mirror TherapyThe 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- To have been diagnosed with Unilateral Spastic Cerebral Palsy.
- To be capable of following and understanding rules.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirror TherapyTherapy 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. | Other | Experimental Group |
| Program without Mirror TherapyBimanual exercises performed with both upper limbs. | Other | Control Group |
Primary outcome
Change in Bimanual Performance
Time frame: Baseline, at 5 weeks and at 9 weeks
How Bimanual Performance, assessed with Children's Hand-use Experience Questionnaire, changes by doing the intervention
7 secondary outcomes
Change in Tactile Registration of the impaired hand.
Time frame: Baseline, at 5 weeks and at 9 weeks
Change in static two-point discrimination of the impaired hand.
Time frame: Baseline, at 5 weeks and at 9 weeks
Change in moving two-point discrimination of the impaired hand.
Time frame: Baseline, at 5 weeks and at 9 weeks
Change in single point localisation of the impaired hand.
Time frame: Baseline, at 5 weeks and at 9 weeks
Change in double simultaneous of the impaired hand.
Time frame: Baseline, at 5 weeks and at 9 weeks
Change in sterognosis of the impaired hand.
Time frame: Baseline, at 5 weeks and at 9 weeks
Self-reported Quality of Life
Time frame: Baseline, at 5 weeks and at 9 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Individual participant dataSharing planned: Yes
Related trials for Hemiplegic Cerebral Palsy
Not yet recruiting
Effect of Robotic Gloves Training on Upper Limb Coordination, Selective Motor Control and Activities of Daily Living in Children With Hemiparetic Cerebral Palsy
Hemiplegic Cerebral Palsy
Not yet recruiting
Effects of Upper Extremity Physiotherapy and Home Exercises on Functional Outcomes in Individuals With Stroke
Stroke
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
Active, not recruiting
Virtual Reality Vs Postural Control Training in Children With Cerebral Palsy
Children With Hemiplegic cp
Recruiting
Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MARIA CARITAT BAGUR CALAFAT, PHD study director
Universitat Internacional de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror Therapy and Program without Mirror Therapy in people with Hemiplegic Cerebral Palsy and Mirror Movement Therapy, run by Universitat Internacional de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bimanual Performance (time frame: Baseline, at 5 weeks and at 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.