Cerebral PalsyBestOf_ARRoWNCT04460833
Feedback in Augmented Reality to Control of Gait Parameters in Children With Cerebral Palsy
A study testing Feedback modalities given through an augmented reality headset in people with Cerebral Palsy and Gait Disorders, Neurologic, run by Fondation Ellen Poidatz at 1 site in France.
Trial summary
Cerebral palsy (CP) describes a group of permanent disorders of the development of movement and posture, causing activity limitation, that are attributed to non progressive disturbances that occurred in the developing fetal or infant brain. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Cerebral Palsy, Gait Disorders, Neurologic, Feedback, Psychological
- What is being tested?
- Feedback modalities given through an augmented reality headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2020to 26 Nov 2021
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children with Cerebral palsy (medical file)
- Age 12-18
- Global Motor Function Classification System (GMFCS) I-III
- Functional Mobility Scale (FMS) minimum 2 for "50 meters"
- Ability to cooperate, to understand and to follow instructions
- Patient affiliated to the French social security system
- Patient volunteers whose the parents given their authorization to participate
Who cannot join
- Medical decision for any reason
- Child or parent decision for any reason
- Inability to cooperate, to understand and to follow instructions
Trial locations and contacts
1 site in 1 country.
France1 site
Fondation Ellen Poidatz
Saint-Fargeau-Ponthierry, Île-de-France Region, 77310
About this study
Official title: Feedback in Augmented Reality to Control the Gait Parameters in Children With Cerebral Palsy (BestOf_ARRoW)
Cerebral palsy (CP) describes a group of permanent disorders of the development of movement and posture, causing activity limitation, that are attributed to non progressive disturbances that occurred in the developing fetal or infant brain. The motor disorder of CP are often accompanied by disturbances of sensation, perception, cognition, communication, and behaviour; by epilepsy, and by secondary musculoskeletal problems.
Motor activities, especially walking, can be affected by many factors including sensory deficits, biomechanical and postural limitations, muscle weakness and spasticity.To provide feedback, during gait rehabilitation is a complementary approach to improve motor learning during the rehabilitation protocol. However, the feedback modalities are multiple and no study has compared these modalities. This study aims to test which feedback modalities could control the gait parameters (speed, cadence, step length) of the child with CP in real-time, through an augmented reality environment.
- Being tested
- Feedback modalities given through an augmented reality headset
- Keywords
- Serious Game, Rehabilitation
- Medical subject headings
- Cerebral Palsy, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback modalities given through an augmented reality headsetDevice
All children wear the augmented reality headset. After a habituation period to the holograms, they start the protocol. It consists of a warm-up session, training session (which three feedback modalities are presented), calibration session (to get the maximal speed and spontaneous speed of the child), and test session. During test session, all the children walk on the 30m corridor. They have 6 feedback modalities + the control, given randomly. On the way out, they have to walk fast as possible ; on the return they have to walk at intermediate speed.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | All children will have the 6 feedback modalities + the control given randomly Receives: Device: Feedback modalities given through an augmented reality headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
walking speed
Walking speed recorded with the augmented reality headset in real-time
Measured: 1 year
step length
step length recorded with the augmented reality headset in real-time
Measured: 1 year
Secondary outcomes (1)
Moizer Questionary
User experience survey; 25 items scored 1 for "I perfectly agree" to 5 "I completly disagree" this item; max score = 25; min score = 125
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start12 Jun 2020
- Primary completion7 Jul 2020
- Study completion26 Nov 2021
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 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ellen Poidatz
- Sponsor type
- University, hospital or other
- Collaborators
- Université Paris-Sud
- Responsible party
- Sponsor
- Investigators
- Eric DESAILLY, PhD, Principal investigator, Fondation Ellen Poidatz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460833
- Sponsor's protocol ID
- BestOf_ARRoW Feedback
- Acronym
- BestOf_ARRoW
- Status last verified
- Jun 2022
- First submitted
- 12 Mar 2020
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guinet AL, Bouyer G, Otmane S, Desailly E. Visual Feedback in Augmented Reality to Walk at Predefined Speed Cross-Sectional Study Including Children With Cerebral Palsy. IEEE Trans Neural Syst Rehabil Eng. 2022;30:2322-2331. doi: 10.1109/TNSRE.2022.3198243. Epub 2022 Aug 22.
PubMed 35951576
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feedback in Augmented Reality to Control the Gait Parameters in Children With Cerebral Palsy (BestOf_ARRoW)
- ClinicalTrials.gov ID
- NCT04460833
- Acronym / sponsor ID
- BestOf_ARRoW / BestOf_ARRoW Feedback
- Keywords
- Serious Game, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fondation Ellen PoidatzUniversity, hospital or other
- Collaborators
- Université Paris-Sud
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 7 Jul 2020 (actual)
- Study completion
- 26 Nov 2021 (actual)
- First posted
- 8 Jul 2020 (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) describes a group of permanent disorders of the development of movement and posture, causing activity limitation, that are attributed to non progressive disturbances that occurred in the developing fetal or infant brain. The motor disorder of CP are often accompanied by disturbances of sensation, perception, cognition, communication, and behaviour; by epilepsy, and by secondary musculoskeletal problems.
Motor activities, especially walking, can be affected by many factors including sensory deficits, biomechanical and postural limitations, muscle weakness and spasticity.To provide feedback, during gait rehabilitation is a complementary approach to improve motor learning during the rehabilitation protocol. However, the feedback modalities are multiple and no study has compared these modalities. This study aims to test which feedback modalities could control the gait parameters (speed, cadence, step length) of the child with CP in real-time, through an augmented reality environment.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Device: Feedback modalities given through an augmented reality headsetAll children will have the 6 feedback modalities + the control given randomly |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Children with Cerebral palsy (medical file)
- Age 12-18
- Global Motor Function Classification System (GMFCS) I-III
- Functional Mobility Scale (FMS) minimum 2 for "50 meters"
- Ability to cooperate, to understand and to follow instructions
Key exclusion criteria (3 listed)
- Medical decision for any reason
- Child or parent decision for any reason
- Inability to cooperate, to understand and to follow instructions
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 |
|---|---|---|
| Feedback modalities given through an augmented reality headsetAll children wear the augmented reality headset. After a habituation period to the holograms, they start the protocol. It consists of a warm-up session, training session (which three feedback modalities are presented), calibration session (to get the maximal speed and spontaneous speed of the child), and test session. During test session, all the children walk on the 30m corridor. They have 6 feedback modalities + the control, given randomly. On the way out, they have to walk fast as possible ; on the return they have to walk at intermediate speed. | Device | Test group |
Primary outcome
walking speed
Time frame: 1 year
Walking speed recorded with the augmented reality headset in real-time
step length
Time frame: 1 year
step length recorded with the augmented reality headset in real-time
1 secondary outcome
Moizer Questionary
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Derived from this study: PubMed 35951576Guinet AL, Bouyer G, Otmane S, Desailly E. Visual Feedback in Augmented Reality to Walk at Predefined Speed Cross-Sectional Study Including Children With Cerebral Palsy. IEEE Trans Neural Syst Rehabil Eng. 2022;30:2322-2331. doi: 10.1109/TNSRE.2022.3198243. Epub 2022 Aug 22.
- Website of the EllenPoidatz Foundation (See Research and Innovation)Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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.
Eric DESAILLY, PhD principal investigator
Fondation Ellen Poidatz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback modalities given through an augmented reality headset in people with Cerebral Palsy and Gait Disorders, Neurologic, run by Fondation Ellen Poidatz at 1 site in France.
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 3 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: finished, as of the sponsor's last update on 23 Jun 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
walking speed (time frame: 1 year). 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 NCT04460833, 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 23 Jun 2022.