Cerebral Palsy, SpasticNCT05557305
Changes in Motor and Cognitive Function on Unilateral Spastic Cerebral Palsy, Associated With Videogame Therapy
A study testing Videogame therapy and Conventional therapy in people with Cerebral Palsy, Spastic and Hemiplegia, Spastic, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
Trial summary
The use of interactive applications associated with position and movement sensors has begun to spread as an option for the reinforcement of physical rehabilitation therapies in patients with congenital or acquired motor disorders as a result of some neurological damage, due to its portability and the relative autonomy… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cerebral Palsy, Spastic, Hemiplegia, Spastic
- What is being tested?
- Videogame therapy and Conventional therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteMexico
- Study dates
- 22 Dec 2022to Dec 2025
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Outpatients
- Both genders
- Reside in Mexico City and the metropolitan area
- Between 5 and 18 years old
- With upper extremity hemiparesis caused by Unilateral Spastic Cerebral Palsy (USCP) on their dominant side or not
- Who are at levels I-III of the Manual Ability Classification System for Children with Cerebral Palsy (MACS)
- Score equal to or greater than 20 on the Fugl-Meyer upper extremity scale.
Who cannot join
- Patients with joint instability (shoulder, elbow, or wrist)
- With severe concomitant medical problems such as congestive heart failure or seizures that prevent adequate attention to the task.
- Severe aphasia
- Hemineglect
- Visual disturbances that are not corrected with glasses
- Uncompensated hearing impairment
- Inability to understand instructions (Token Test < 17)
- Patients receiving concurrent therapies.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Pediatría
Mexico City, Coyoacán, CDMX, 04530
Ana Maria Escalante-Gonzalbo, MCSc, 5556225730, aescalan@ifc.unam.mx
About this study
Official title: Evaluation of the Usability, Safety, and Possible Beneficial Effects on Motor and Cognitive Functions Associated With Using a Neuro-rehabilitation Platform With Video Games in Pediatric Patients With Unilateral Spastic Cerebral Palsy
The use of interactive applications associated with position and movement sensors has begun to spread as an option for the reinforcement of physical rehabilitation therapies in patients with congenital or acquired motor disorders as a result of some neurological damage, due to its portability and the relative autonomy granted to the patient. However, the results of its effectiveness and impact continue to be scarce compared to the traditional therapy used for rehabilitation. The aim of this study is to explore possible benefits associated with occupational therapy with video games in patients with unilateral spastic cerebral palsy, comparing them with conventional therapy.
A randomized pilot study will be carried out, with a control group. The intervention will consist of the application of a virtual rehabilitation program for the experimental group while the control group will receive only conventional therapy. Before and after the said intervention, standardized tests will be applied to evaluate both motor function and the cognitive performance of the participants.
Read the detailed description
This intervention protocol aims to validate five interactive applications for neurorehabilitation, as an effective therapeutic complement for the rehabilitation of children with unilateral cerebral palsy, compared to conventional rehabilitation.
The intervention contemplates first a phase of application of standardized tests in the Cognitive enablement lab of the National Institute of pediatrics (INP) in Mexico City, to determine, among other things, if the patient meets the established inclusion criteria. Patients who meet these criteria will be randomly assigned to the control or experimental group.
In the same INP, standardized tests will be applied to record their motor and cognitive capacity at the beginning of the protocol. Patients in the experimental group will receive two 50-minute video game rehabilitation sessions per week, for 10 weeks, under the supervision of trained personnel from the Laboratory of Applications for Neurorehabilitation (LANR). Control group patients will receive 10 weeks of occupational therapy, as prescribed by their treating physician.
All standardized tests will be applied again to the participants of both groups after the 10 weeks of intervention, and again six months later, to measure the persistence of the changes.
In the case of the experimental group, five interactive applications will be tested, each with a different sensor and virtual environment, as well as its own therapeutic objective, these applications are part of the National Autonomous University of Mexico (UNAM) virtual rehabilitation platform.
- Conditions
- Cerebral Palsy, Spastic, Hemiplegia, Spastic
- Being tested
- Videogame therapy, Conventional therapy
- Keywords
- virtual rehabilitation, video games, motor function, spastic hemiparesis, cerebral palsy, unilateral spastic cerebral palsy
- Medical subject headings
- Cerebral Palsy, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videogame therapyDevice
Also called Virtual rehabilitation
There will be 5 video game-type applications for virtual therapy, each with a specific therapeutic objective, which will be administered by trained personnel, depending on the characteristics of each patient.
Conventional therapyOther
Also called Occupational therapy
Occupational therapy with different play materials
| Study group | Role | What they receive |
|---|---|---|
| Videogame therapy | Experimental | The participants of the experimental group will only undergo video game therapy and will be called twice a week to perform supervised video game rehabilitation therapy, for a period of 45-50 minutes per session, for 10 weeks Receives: Device: Videogame therapy |
| Conventional therapy | Active comparator | The participants in the control group will undergo the conventional therapy prescribed by their treating physician, at the INP they are prescribed occupational therapy, which is usually focused on game activities with balls, dice, cubes, tying ropes, etc., twice a week for 10 weeks. Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Fugl-Meyer Assesment for upper extremity (FMUE)
Level of motor deficit, evaluated using the Fugl-Meyer Assessment scale for the upper limb (0-66), with 66 meaning no defficit.
Measured: Baseline, 10 Weeks, 6 months
Change in the Quality of Upper Extremity Skills Test (QUEST)
Upper limb motor skill level, obtained through the Quality of Upper Extremity Skills Test (less than 0 to 100), with 100 being the best quality of movement.
Measured: Baseline, 10 Weeks, 6 months
Secondary outcomes (5)
Change in the PedsQl pediatric quality of life questionnaire
Level of independence in performing activities of daily living (ADLs), assessed using the PedsQl pediatric quality of life questionnaire (0-132) with 0 as the highest score.
Measured: Baseline, 10 Weeks, 6 months
Change in the digital version of the Trail Making Test (TMT-A)
Changes in cognitive function in terms of speed of executive functions and attention, measured by a digitized version of the Trail Making Test A.
Measured: Baseline, 10 Weeks, 6 months
Change in the digital version of the Corsi cube test.
Changes in working memory measured by the Corsi Cubes test.
Measured: Baseline, 10 Weeks, 6 months
Change in the digital version of the Perception of differences test (FACES)
Changes in visual perception, using the perception of differences test
Measured: Baseline, 10 Weeks, 6 months
Change in the Digital implementation of the Go-NoGo paradigm.
Changes in inhibition and flexibility functions, measured using a digital implementation of the Go-NoGo paradigm
Measured: Baseline, 10 Weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start22 Dec 2022
- Primary completionMay 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy, SpasticStudies 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
- Model description
- Pilot, randomized, controlled, longitudinal trial
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Pediatrics, Mexico
- Responsible party
- Principal investigator, Ana María Escalante Gonzalbo, Universidad Nacional Autonoma de Mexico
- Investigators
- Ana María Escalante-Gonzalbo, MCompSci, Principal investigator, National University of Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557305
- Sponsor's protocol ID
- 2022/054
- Status last verified
- May 2024
- First submitted
- 21 Sep 2022
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Escalante-Gonzalbo AM, Ramirez-Graullera YS, Pasantes H, Aguilar-Chale JJ, Sanchez-Castillo GI, Escutia-Macedo XA, Briseno-Soriano TM, Franco-Castro P, Estrada-Rosales AL, Vazquez-Abundes SE, Andrade-Morales D, Hernandez-Franco J, Palafox L. Safety, Feasibility, and Acceptability of a New Virtual Rehabilitation Platform: A Supervised Pilot Study. Rehabil Process Outcome. 2021 Aug 7;10:11795727211033279. doi: 10.1177/11795727211033279. eCollection 2021.
PubMed 34987304
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Usability, Safety, and Possible Beneficial Effects on Motor and Cognitive Functions Associated With Using a Neuro-rehabilitation Platform With Video Games in Pediatric Patients With Unilateral Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05557305
- Acronym / sponsor ID
- 2022/054
- Conditions
- Cerebral Palsy, Spastic, Hemiplegia, Spastic
- Keywords
- virtual rehabilitation, video games, motor function, spastic hemiparesis, cerebral palsy, unilateral spastic cerebral palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Universidad Nacional Autonoma de MexicoUniversity, hospital or other
- Collaborators
- National Institute of Pediatrics, Mexico
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Sep 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.
The use of interactive applications associated with position and movement sensors has begun to spread as an option for the reinforcement of physical rehabilitation therapies in patients with congenital or acquired motor disorders as a result of some neurological damage, due to its portability and the relative autonomy granted to the patient. However, the results of its effectiveness and impact continue to be scarce compared to the traditional therapy used for rehabilitation. The aim of this study is to explore possible benefits associated with occupational therapy with video games in patients with unilateral spastic cerebral palsy, comparing them with conventional therapy.
A randomized pilot study will be carried out, with a control group. The intervention will consist of the application of a virtual rehabilitation program for the experimental group while the control group will receive only conventional therapy. Before and after the said intervention, standardized tests will be applied to evaluate both motor function and the cognitive performance of the participants.
Detailed description
This intervention protocol aims to validate five interactive applications for neurorehabilitation, as an effective therapeutic complement for the rehabilitation of children with unilateral cerebral palsy, compared to conventional rehabilitation.
The intervention contemplates first a phase of application of standardized tests in the Cognitive enablement lab of the National Institute of pediatrics (INP) in Mexico City, to determine, among other things, if the patient meets the established inclusion criteria. Patients who meet these criteria will be randomly assigned to the control or experimental group.
In the same INP, standardized tests will be applied to record their motor and cognitive capacity at the beginning of the protocol. Patients in the experimental group will receive two 50-minute video game rehabilitation sessions per week, for 10 weeks, under the supervision of trained personnel from the Laboratory of Applications for Neurorehabilitation (LANR). Control group patients will receive 10 weeks of occupational therapy, as prescribed by their treating physician.
All standardized tests will be applied again to the participants of both groups after the 10 weeks of intervention, and again six months later, to measure the persistence of the changes.
In the case of the experimental group, five interactive applications will be tested, each with a different sensor and virtual environment, as well as its own therapeutic objective, these applications are part of the National Autonomous University of Mexico (UNAM) virtual rehabilitation platform.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot, randomized, controlled, longitudinal trial
| Arm | Type | Receives |
|---|---|---|
| Videogame therapy | Experimental | Device: Videogame therapyThe participants of the experimental group will only undergo video game therapy and will be called twice a week to perform supervised video game rehabilitation therapy, for a period of 45-50 minutes per session, for 10 weeks |
| Conventional therapy | Active comparator | Other: Conventional therapyThe participants in the control group will undergo the conventional therapy prescribed by their treating physician, at the INP they are prescribed occupational therapy, which is usually focused on game activities with balls, dice, cubes, tying ropes, etc., twice a week for 10 weeks. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Outpatients
- Both genders
- Reside in Mexico City and the metropolitan area
- Between 5 and 18 years old
- With upper extremity hemiparesis caused by Unilateral Spastic Cerebral Palsy (USCP) on their dominant side or not
Key exclusion criteria (8 listed)
- Patients with joint instability (shoulder, elbow, or wrist)
- With severe concomitant medical problems such as congestive heart failure or seizures that prevent adequate attention to the task.
- Severe aphasia
- Hemineglect
- Visual disturbances that are not corrected with glasses
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 |
|---|---|---|
| Videogame therapyAlso: Virtual rehabilitationThere will be 5 video game-type applications for virtual therapy, each with a specific therapeutic objective, which will be administered by trained personnel, depending on the characteristics of each patient. | Device | Videogame therapy |
| Conventional therapyAlso: Occupational therapyOccupational therapy with different play materials | Other | Conventional therapy |
Primary outcome
Change in the Fugl-Meyer Assesment for upper extremity (FMUE)
Time frame: Baseline, 10 Weeks, 6 months
Level of motor deficit, evaluated using the Fugl-Meyer Assessment scale for the upper limb (0-66), with 66 meaning no defficit.
Change in the Quality of Upper Extremity Skills Test (QUEST)
Time frame: Baseline, 10 Weeks, 6 months
Upper limb motor skill level, obtained through the Quality of Upper Extremity Skills Test (less than 0 to 100), with 100 being the best quality of movement.
5 secondary outcomes
Change in the PedsQl pediatric quality of life questionnaire
Time frame: Baseline, 10 Weeks, 6 months
Change in the digital version of the Trail Making Test (TMT-A)
Time frame: Baseline, 10 Weeks, 6 months
Change in the digital version of the Corsi cube test.
Time frame: Baseline, 10 Weeks, 6 months
Change in the digital version of the Perception of differences test (FACES)
Time frame: Baseline, 10 Weeks, 6 months
Change in the Digital implementation of the Go-NoGo paradigm.
Time frame: Baseline, 10 Weeks, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Results publication: PubMed 34987304Escalante-Gonzalbo AM, Ramirez-Graullera YS, Pasantes H, Aguilar-Chale JJ, Sanchez-Castillo GI, Escutia-Macedo XA, Briseno-Soriano TM, Franco-Castro P, Estrada-Rosales AL, Vazquez-Abundes SE, Andrade-Morales D, Hernandez-Franco J, Palafox L. Safety, Feasibility, and Acceptability of a New Virtual Rehabilitation Platform: A Supervised Pilot Study. Rehabil Process Outcome. 2021 Aug 7;10:11795727211033279. doi: 10.1177/11795727211033279. eCollection 2021.
- Web Page of the Research and Development Laboratory of Interactive Applications for Neuro-Rehabilitation (LANR) of the UNAMLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ana María Escalante-Gonzalbo, MCompSci principal investigator
National University of Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videogame therapy and Conventional therapy in people with Cerebral Palsy, Spastic and Hemiplegia, Spastic, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
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 7 inclusion and 8 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 7 May 2024. 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 Mexico. 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?
Contact Ana María Escalante-Gonzalbo, MCompSci (525556225730, aescalan@ifc.unam.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Fugl-Meyer Assesment for upper extremity (FMUE) (time frame: Baseline, 10 Weeks, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05557305, which also lists 1 linked publication.
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 7 May 2024.