StrokeNCT05661396
Therapeutic Serious Game and Rehabilitation of Stroke Patient
A study testing Serious game rehabilitation in people with Stroke and Unilateral Spatial Neglect, run by Hopitaux de Saint-Maurice.
Trial summary
The growing field of new technologies offers new perspectives for neurorehabilitation. Serious games are a promising solution in the rehabilitation of cognitive impairments, and they may be useful in the rehabilitation of unilateral spatial neglect. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Unilateral Spatial Neglect
- What is being tested?
- Serious game rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 3 Nov 2016to 6 Sep 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral spatial neglect syndrome
- Right cerebral lesion
Who cannot join
- Epilepsia
- General mental deterioration
- Psychiatric disorder
- No prior history of neurological disease
About this study
Official title: Development of a Therapeutic Serious Game in the Rehabilitation of Stroke Patient
The growing field of new technologies offers new perspectives for neurorehabilitation. Serious games are a promising solution in the rehabilitation of cognitive impairments, and they may be useful in the rehabilitation of unilateral spatial neglect. The investigators developed a rehabilitation program for visual exploration training with a serious game and investigated its efficiency.
Six patients with unilateral spatial neglect after a right hemispheric stroke were recruited. Three patients assigned to the experimental group received both serious game training and conventional rehabilitation, and three assigned to the control group received only conventional rehabilitation. The investigators compared the two groups after rehabilitation.
- Conditions
- Stroke, Unilateral Spatial Neglect
- Being tested
- Serious game rehabilitation
- Keywords
- serious game, stroke, unilateral spatial neglect, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious game rehabilitationBehavioural
Three patients received therapeutic serious game rehabilitation in addition to conventional rehabilitation. The serious game was proposed to be played three times per week for four weeks, for a total of 12 sessions, with 15 min per session (= 45 minutes per week).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Behavioral: Serious game rehabilitation |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bells test
35 bells are spatially distributed among distractors on sheet of paper (15 on the left side, 5 on the center and 15 on the right side). Subjects have to cancel as many bells as possible. The number of omissions on the left and on the right side is recorded.
Measured: up to 4 weeks
Secondary outcomes (3)
Bisection of lines
2 lines of 200 millimeters are presented on a sheet of paper. Subjects have to mark the middle of the lines. The deviation from the objective middle is measured in millimeter.
Measured: up to 4 weeks
Ogden scene copying
Copying of the 'Ogden scene' required participants to copy a scene that consisted of 2 trees, a fence and a house (shown from left to right side of the page). Each stroke in the scene to be copied was counted as a point; each omitted stroke was scored as one error, and each distorted or misplaced stroke was scored as one-half of an error (/4).
Measured: up to 4 weeks
Reading task
A text of 116 words is presented with 61 words on the left side and 55 on the right side. Subjects have to read this text. Number of omissions on the left and on the right side is recorded.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start3 Nov 2016
- Primary completion3 Jun 2017
- Study completion6 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopitaux de Saint-Maurice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661396
- Sponsor's protocol ID
- NSU-SG 5
- Status last verified
- Dec 2022
- First submitted
- 21 Nov 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Therapeutic Serious Game in the Rehabilitation of Stroke Patient
- ClinicalTrials.gov ID
- NCT05661396
- Acronym / sponsor ID
- NSU-SG 5
- Conditions
- Stroke, Unilateral Spatial Neglect
- Keywords
- serious game, stroke, unilateral spatial neglect, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Hopitaux de Saint-MauriceUniversity, hospital or other
- Study start
- 3 Nov 2016 (actual)
- Primary completion
- 3 Jun 2017 (actual)
- Study completion
- 6 Sep 2017 (actual)
- First posted
- 22 Dec 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 growing field of new technologies offers new perspectives for neurorehabilitation. Serious games are a promising solution in the rehabilitation of cognitive impairments, and they may be useful in the rehabilitation of unilateral spatial neglect. The investigators developed a rehabilitation program for visual exploration training with a serious game and investigated its efficiency.
Six patients with unilateral spatial neglect after a right hemispheric stroke were recruited. Three patients assigned to the experimental group received both serious game training and conventional rehabilitation, and three assigned to the control group received only conventional rehabilitation. The investigators compared the two groups after rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Serious game rehabilitation |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unilateral spatial neglect syndrome
- Right cerebral lesion
Key exclusion criteria (4 listed)
- Epilepsia
- General mental deterioration
- Psychiatric disorder
- No prior history of neurological disease
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 |
|---|---|---|
| Serious game rehabilitationThree patients received therapeutic serious game rehabilitation in addition to conventional rehabilitation. The serious game was proposed to be played three times per week for four weeks, for a total of 12 sessions, with 15 min per session (= 45 minutes per week). | Behavioural | Experimental group |
Primary outcome
Bells test
Time frame: up to 4 weeks
35 bells are spatially distributed among distractors on sheet of paper (15 on the left side, 5 on the center and 15 on the right side). Subjects have to cancel as many bells as possible. The number of omissions on the left and on the right side is recorded.
3 secondary outcomes
Bisection of lines
Time frame: up to 4 weeks
Ogden scene copying
Time frame: up to 4 weeks
Reading task
Time frame: up to 4 weeks
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 22 Dec 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Serious game rehabilitation in people with Stroke and Unilateral Spatial Neglect, run by Hopitaux de Saint-Maurice.
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 4 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 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Bells test (time frame: up to 4 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 22 Dec 2022.