Cerebral Palsy, SpasticNCT05131724
Effectiveness of Virtual Reality on Functional Mobility During Treadmill Training in Children With Cerebral Palsy
A study testing Treadmill training with virtual reality and Treadmill training in people with Cerebral Palsy, Spastic, run by University of Vic - Central University of Catalonia at 1 site in Spain.
Trial summary
Cerebral palsy (CP), which occurs as a consequence of brain damage, has multiple deficits such as a global reduction of motor cortical activity during movement execution and inadequate processing of corticospinal and somatosensory circuits. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- Treadmill training with virtual reality and Treadmill training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2022to Sep 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Medical diagnosis of spastic cerebral palsy
- Motor function levels I to III according to the Gross Motor Function Classification System
- Independent walking was acquired for more than 12 months.
- Able to ambulate for at least 10 meters with or without aids.
Who cannot join
- Orthopaedic surgery on the lower limbs in the past 12 months.
- Scheduled surgery during the period of the study.
- Orthopaedic deformities with surgery indication.
- Uncontrolled seizure disorder.
- Metallic implant in the skull.
- Hearing aid.
- Have received toxic botulin injections in the past 6 months.
- Significant cognitive or visual impairment.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Univeristy of Vic - Central University of Catalonia
Vic, Barcelona, 08500
Mirari Ochandorena-Acha, PhD, +34 659 408 555, mirari.ochandorena@uvic.cat
About this study
Official title: Effectiveness of Virtual Reality on Functional Mobility During Treadmill Training in Children With Cerebral Palsy: a Randomized Clinical Trial (VirtWalkCP Project)
Cerebral palsy (CP), which occurs as a consequence of brain damage, has multiple deficits such as a global reduction of motor cortical activity during movement execution and inadequate processing of corticospinal and somatosensory circuits. Global registers estimate that it occurs in two to three of 1.000 live births, and spasticity is the most common disorder, occurring in 80% of children with CP. Spasticity might affect both upper and lower limbs, resulting in other deficits in joint mobility, postural reactions, selective motor control, balance, and gait. This set of impairments and deficits may lead to limitations in functional ability and autonomy in the performance of daily living activities, physical fitness, quality of life, and/or ability to participate in games and sports activities compared to neurotypical peers of the same age.
Walking is considered one of the most important activities in daily life, as it is essential for activities of daily living and social participation. Children with Gross Motor Function Classification System (GMFCS) levels I, II, and III show potential for walking, and around 75% of CP children are ambulatory. However, abnormalities in neural control and muscle weakness contribute to several gait characteristics such as slow velocity, decreased stride length, increased stance phase percentage, and increased peak ankle dorsiflexion and knee flexion, and peak hip extension moments. Consequently, this gait pattern contributes to postural instability and increased fall risk in children with CP, among others.
Read the detailed description
The main objective of the present study is to evaluate the effectiveness of treadmill gait training and virtual reality comparing to treadmill gait training on functional mobility in infants with spastic cerebral palsy.
The study design is a two-arm randomized clinical trial, single-center and single-blind (evaluators). The sample will be recruited at the Hospital General de Vic, and the study will be conducted at the Universitat de Vic - Universitat Central de Catalunya (UVic-UCC).
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- Treadmill training with virtual reality, Treadmill training
- Keywords
- "Rehabilitation"[Mesh], "Mobility Limitation"[Mesh], "Virtual Reality"[Mesh]
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill training with virtual realityOther
The virtual environment will be composed of obstacles, different paths, and narrow and deviated corridors. Walking through this environment will require the infant to coordinate walking behaviour and adjust the length, height, and width of steps to negotiate the obstacles on the television screen placed at the infant's eye level in front of the treadmill. The speed, orientation, size, frequency of appearance, and shape of the obstacles will be manipulated according to individual performance following a standardized protocol. The virtual system will provide visual and auditory feedback on the success or failure of the activity to enhance motor learning. In addition, the characteristics of the environment (e.g., visibility, configuration, and distractions) will be adjusted to increase the complexity of the training.
Treadmill trainingOther
The RAM870A of the Medisoft treadmill will be used. Two treadmill training sessions will be held before the onset of the intervention to familiarize the children with the equipment. During these two sessions, the treadmill training and speed will be set according to the following procedures: the ground walking speed of each child will be determined through the baseline 6MWT, then the training velocity will be set at 50% of the maximum ground speed established during the 6MWT and increased gradually based on the tolerance of each child (i.e., no complaint of fatigue, heart rate not exceeding 70% of the maximum heart rate, and a lack of gait shuffling, buckling or dragging steps more than 5 seconds during walking).
| Study group | Role | What they receive |
|---|---|---|
| Treadmill training | Active comparator | The treadmill training would be 10 sessions over 2 weeks with 30 minutes for each session (5-min warm-up; 20 min gait training; 5-min cool-down). During the sessions, treadmill speed will be maintained at 60 to 80% of the maximum speed established on an exertion test. The child will walk at 60% maximum speed in the first and final five minutes and 80% in the middle 20 minutes. Receives: Other: Treadmill training |
| Virtual reality | Experimental | Infants in the TTVR group will perform gait training on the treadmill simultaneously with virtual reality. Receives: Other: Treadmill training with virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional mobility change
The 6-Minute Walk Test (6MWT) will be performed according to the recommendations. The test will be performed once in a 10m course layout. Participants will receive standardized instructions and encouragement. The test-retest interclass correlation coefficient of this test is 0.98. The estimated time to perform the test is 10 minutes.
Measured: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks).
Secondary outcomes (7)
Static balance
The evaluation of static balance will be performed on a stabilometric platform (SystemTM SD - Biodex), which allows stabilometric analysis based on oscillations of the centre of pressure. The children will be instructed to remain standing on the platform barefoot, with arms alongside the body, gazed fixed on a point that will appear on the platform's integrated screen (at eye level, adjusted for each child), with the base of the foot free and heels aligned. The platform also has support rails if the participant loses balance during the test and needs to hold on. Readings will be taken for 30 seconds in two conditions (eyes open and eyes closed). Displacement will be measured from the oscillations of the centre of pressure in the X (anterior-posterior) and Y (medial-lateral) axes in both conditions. The test is estimated to last 5 minutes.
Measured: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)
Dynamic balance
The outcome will be assessed by the Beg Balance Scale will be evaluated the dynamic or functional balance. This simple 14-item measure addresses the performance of functional balance common to daily living. Each item has a five-option scale ranging from 0 to 4 points, with a maximum overall score of 56. The points are based on the time in which a position is maintained, the distance an upper limb is able to reach in front of the body, and the time needed to complete the task. The inter-rater reliability is 0.99, demonstrating the excellent reliability of this instrument. The total execution time is approximately 20 minutes.
Measured: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)
Walking speed
The outcome will be assessed by the 10 Meter Walk Test (10MWT), which has excellent measurement properties and is a task-specific objective measure of stepping or walking speed within an indoor environment. The test can be completed with or without a gait trainer and is not diagnostic specific. Infants will be instructed to walk 14 meters, and their speed will be measured for 10 meters to exclude acceleration at the beginning of the gait and deceleration at the end of the gait. Physical facilitation for one step will be provided for children who cannot initiate steps within a 30-second time frame. A maximum time of 10 minutes will be provided to complete the 10m. A change of 0.1 m/s will be considered to be clinically meaningful. The inter-rater reliability of this instrument is very high, between 0.89 and 1.00(64). The total execution time is approximately 10 minutes.
Measured: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)
Gross motor function
The outcome will be assessed by the gross motor function measure-item set (GMFM-IS). This tool is an updated version of GMFM-66 and is considered accurate, time-efficient, and suitable for research. This scale allows quantifying the infants' gross motor function in different positions (lying down and rolling; sitting; crawling and kneeling; standing; walking, running, and jumping), scoring each item from 0 to 3 points, with higher scores denoting a better performance. Clinically meaningful change for the GMFM in children with CP aged 1.5-7 years old is 1.23 for individuals classified as GMFCS level III. The test is estimated to last 10 minutes.
Measured: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)
Functional independence
The outcome will be assessed by the Functional Independence Measure for Children (WeeFIM), which has excellent measurement properties to measure consistent performance of activities of daily living, functional independence, and burden of care in children with disabilities. It is a semi-structured interview that is guided by a specific manual to determine the level of assistance required for (1) self-care, (2) transfers and mobility, (3) cognition and communication. A total of 18 items are scored on a scale of 1 (indicating total assistance required for completion of the task) to 7 (complete independence), giving a total score out of a possible 126. The WeeFIM will be completed by the parents or guardians of each child.
Measured: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)
Health-related quality of life
The outcome will be assessed using the Pediatric Quality of Life Inventory (PedsQoL). The 23-item scale encompasses: 1) Physical Functioning (8 items), 2) Emotional Functioning (5 items), 3) Social Functioning (5 items), and 4) School Functioning (5 items), and will be completed by the parents or guardian of each child. The instructions ask how much of a problem each item has been during the past 1 month. A 5-point response scale is utilized (0= never a problem; 1= almost never a problem; 2= sometimes a problem; 3= often a problem; 4= almost always a problem).
Measured: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)
Occupational participation
The outcome will be assessed using the Children Participation Questionnaire (CPQ). This questionnaire will be completed by the parents or guardians of each child. It documents the child's participation in 6 occupational areas: 1) activities of daily living; 2) instrumental activities; 3) play; 4) leisure; 5) social participation; and 6) education. Parents will report the intensity of the level of independence and the infant's enjoyment and satisfaction. It consists of 44 items that are scored on a 6-point scale (1 - 6). A higher score is considered as higher enjoyment or satisfaction.
Measured: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study startSep 2022 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vic - Central University of Catalonia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirari Ochandorena Acha, University of Vic - Central University of Catalonia
- Investigators
- Mirari Ochandorena-Acha, PhD, Principal investigator, University of Vic - Central University of Catalonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131724
- Sponsor's protocol ID
- VirtWalkCP
- Status last verified
- Nov 2021
- First submitted
- 1 Nov 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All IPD that underlie results in a publication
Publications
Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23. doi: 10.1111/j.1469-8749.1997.tb07414.x.
PubMed 9183258Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.
PubMed 32086598Chiu HC, Ada L, Bania TA. Mechanically assisted walking training for walking, participation, and quality of life in children with cerebral palsy. Cochrane Database Syst Rev. 2020 Nov 18;11(11):CD013114. doi: 10.1002/14651858.CD013114.pub2.
PubMed 33202482Grecco LAC, Hugo P, Sampaio LMM, Oliveira CS. Evidence of the effect of treadmill training on children with cerebral palsy: A systematic review. Clin Exp Med Lett [Internet]. 2012;53(2):95-100. Available from: http://www.ceml-online.com/fulltxt.php?ICID=883582
Grecco LA, Tomita SM, Christovao TC, Pasini H, Sampaio LM, Oliveira CS. Effect of treadmill gait training on static and functional balance in children with cerebral palsy: a randomized controlled trial. Braz J Phys Ther. 2013 Jan-Feb;17(1):17-23. doi: 10.1590/s1413-35552012005000066.
PubMed 23538455Ochandorena-Acha M, Terradas-Monllor M, Nunes Cabrera TF, Torrabias Rodas M, Grau S. Effectiveness of virtual reality on functional mobility during treadmill training in children with cerebral palsy: a single-blind, two-arm parallel group randomised clinical trial (VirtWalkCP Project). BMJ Open. 2022 Nov 3;12(11):e061988. doi: 10.1136/bmjopen-2022-061988.
PubMed 36328390
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality on Functional Mobility During Treadmill Training in Children With Cerebral Palsy: a Randomized Clinical Trial (VirtWalkCP Project)
- ClinicalTrials.gov ID
- NCT05131724
- Acronym / sponsor ID
- VirtWalkCP
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- "Rehabilitation"[Mesh], "Mobility Limitation"[Mesh], "Virtual Reality"[Mesh]
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Vic - Central University of CataloniaUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 23 Nov 2021 (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.
Cerebral palsy (CP), which occurs as a consequence of brain damage, has multiple deficits such as a global reduction of motor cortical activity during movement execution and inadequate processing of corticospinal and somatosensory circuits. Global registers estimate that it occurs in two to three of 1.000 live births, and spasticity is the most common disorder, occurring in 80% of children with CP. Spasticity might affect both upper and lower limbs, resulting in other deficits in joint mobility, postural reactions, selective motor control, balance, and gait. This set of impairments and deficits may lead to limitations in functional ability and autonomy in the performance of daily living activities, physical fitness, quality of life, and/or ability to participate in games and sports activities compared to neurotypical peers of the same age.
Walking is considered one of the most important activities in daily life, as it is essential for activities of daily living and social participation. Children with Gross Motor Function Classification System (GMFCS) levels I, II, and III show potential for walking, and around 75% of CP children are ambulatory. However, abnormalities in neural control and muscle weakness contribute to several gait characteristics such as slow velocity, decreased stride length, increased stance phase percentage, and increased peak ankle dorsiflexion and knee flexion, and peak hip extension moments. Consequently, this gait pattern contributes to postural instability and increased fall risk in children with CP, among others.
Detailed description
The main objective of the present study is to evaluate the effectiveness of treadmill gait training and virtual reality comparing to treadmill gait training on functional mobility in infants with spastic cerebral palsy.
The study design is a two-arm randomized clinical trial, single-center and single-blind (evaluators). The sample will be recruited at the Hospital General de Vic, and the study will be conducted at the Universitat de Vic - Universitat Central de Catalunya (UVic-UCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treadmill training | Active comparator | Other: Treadmill trainingThe treadmill training would be 10 sessions over 2 weeks with 30 minutes for each session (5-min warm-up; 20 min gait training; 5-min cool-down). During the sessions, treadmill speed will be maintained at 60 to 80% of the maximum speed established on an exertion test. The child will walk at 60% maximum speed in the first and final five minutes and 80% in the middle 20 minutes. |
| Virtual reality | Experimental | Other: Treadmill training with virtual realityInfants in the TTVR group will perform gait training on the treadmill simultaneously with virtual reality. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Medical diagnosis of spastic cerebral palsy
- Motor function levels I to III according to the Gross Motor Function Classification System
- Independent walking was acquired for more than 12 months.
- Able to ambulate for at least 10 meters with or without aids.
Key exclusion criteria (8 listed)
- Orthopaedic surgery on the lower limbs in the past 12 months.
- Scheduled surgery during the period of the study.
- Orthopaedic deformities with surgery indication.
- Uncontrolled seizure disorder.
- Metallic implant in the skull.
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 |
|---|---|---|
| Treadmill training with virtual realityThe virtual environment will be composed of obstacles, different paths, and narrow and deviated corridors. Walking through this environment will require the infant to coordinate walking behaviour and adjust the length, height, and width of steps to negotiate the obstacles on the television screen placed at the infant's eye level in front of the treadmill. The speed, orientation, size, frequency of appearance, and shape of the obstacles will be manipulated according to individual performance following a standardized protocol. The virtual system will provide visual and auditory feedback on the success or failure of the activity to enhance motor learning. In addition, the characteristics of the environment (e.g., visibility, configuration, and distractions) will be adjusted to increase the complexity of the training. | Other | Virtual reality |
| Treadmill trainingThe RAM870A of the Medisoft treadmill will be used. Two treadmill training sessions will be held before the onset of the intervention to familiarize the children with the equipment. During these two sessions, the treadmill training and speed will be set according to the following procedures: the ground walking speed of each child will be determined through the baseline 6MWT, then the training velocity will be set at 50% of the maximum ground speed established during the 6MWT and increased gradually based on the tolerance of each child (i.e., no complaint of fatigue, heart rate not exceeding 70% of the maximum heart rate, and a lack of gait shuffling, buckling or dragging steps more than 5 seconds during walking). | Other | Treadmill training |
Primary outcome
Functional mobility change
Time frame: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks).
The 6-Minute Walk Test (6MWT) will be performed according to the recommendations. The test will be performed once in a 10m course layout. Participants will receive standardized instructions and encouragement. The test-retest interclass correlation coefficient of this test is 0.98. The estimated time to perform the test is 10 minutes.
7 secondary outcomes
Static balance
Time frame: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)
Dynamic balance
Time frame: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)
Walking speed
Time frame: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)
Gross motor function
Time frame: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)
Functional independence
Time frame: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)
Health-related quality of life
Time frame: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)
Occupational participation
Time frame: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Background: PubMed 9183258Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23. doi: 10.1111/j.1469-8749.1997.tb07414.x.
- Background: PubMed 32086598Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.
- Background: PubMed 33202482Chiu HC, Ada L, Bania TA. Mechanically assisted walking training for walking, participation, and quality of life in children with cerebral palsy. Cochrane Database Syst Rev. 2020 Nov 18;11(11):CD013114. doi: 10.1002/14651858.CD013114.pub2.
- BackgroundGrecco LAC, Hugo P, Sampaio LMM, Oliveira CS. Evidence of the effect of treadmill training on children with cerebral palsy: A systematic review. Clin Exp Med Lett [Internet]. 2012;53(2):95-100. Available from: http://www.ceml-online.com/fulltxt.php?ICID=883582
- Background: PubMed 23538455Grecco LA, Tomita SM, Christovao TC, Pasini H, Sampaio LM, Oliveira CS. Effect of treadmill gait training on static and functional balance in children with cerebral palsy: a randomized controlled trial. Braz J Phys Ther. 2013 Jan-Feb;17(1):17-23. doi: 10.1590/s1413-35552012005000066.
- Derived from this study: PubMed 36328390Ochandorena-Acha M, Terradas-Monllor M, Nunes Cabrera TF, Torrabias Rodas M, Grau S. Effectiveness of virtual reality on functional mobility during treadmill training in children with cerebral palsy: a single-blind, two-arm parallel group randomised clinical trial (VirtWalkCP Project). BMJ Open. 2022 Nov 3;12(11):e061988. doi: 10.1136/bmjopen-2022-061988.
- Individual participant dataSharing planned: No. All IPD that underlie results in a publication
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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.
Mirari Ochandorena-Acha, PhD principal investigator
University of Vic - Central University of Catalonia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill training with virtual reality and Treadmill training in people with Cerebral Palsy, Spastic, run by University of Vic - Central University of Catalonia 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 4 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 30 Nov 2021. 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?
Contact Mirari Ochandorena-Acha, PhD (+34 659 408 555, mirari.ochandorena@uvic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional mobility change (time frame: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks).). 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 NCT05131724, which also lists 6 linked publications.
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 30 Nov 2021.