StrokeNCT05805748
Serious Game Therapy in Neglect Patients
A study testing serious game rehabilitation in people with Stroke and Unilateral Spatial Neglect, run by Hopitaux de Saint-Maurice at 1 site in France.
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
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 6 Sep 2017to 1 Jul 2022
- 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
Trial locations and contacts
1 site in 1 country.
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. Investigators developed a rehabilitation program for visual exploration training with a serious game and investigated its efficiency. Twelve patients with unilateral spatial neglect after a right hemispheric stroke were recruited. Six patients assigned to a group received both serious game training and conventional rehabilitation, and after only conventional rehabilitation; and six patients assigned to another group received first conventional rehabilitation and then serious game training and conventional rehabilitation. The investigators compared the two groups after rehabilitation.
- Conditions
- Stroke, Unilateral Spatial Neglect
- Being tested
- serious game rehabilitation
- Keywords
- rehabilitation, new technology, unilateral spatial neglect
- 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
The SG rehabilitation was proposed to be played four times per week for three weeks, for a total of 12 sessions, with 15 min per session (= 60 minutes per week). Conventional rehabilitation comprised five sessions of 45 min of neuropsychological rehabilitation using classical exploration training (= 225 minutes per week).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Each patient received 2 rehabilitations : a serious game training and a conventional rehabilitation first (during 3 weeks) and then conventional rehabilitation alone (during 3 weeks) Receives: Behavioral: serious game rehabilitation |
| Group 2 | Active comparator | Each patient received 2 rehabilitations for 3 weeks: a conventional rehabilitation first (during 3 weeks) and then both serious game training and a conventional rehabilitation (during 3 weeks) Receives: Behavioral: serious game rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Inattention Test (BIT)
Behavioral Inattention Test (Wilson et al., 1987) (BIT) including the first part of conventional subtests: star and letter cancellation, line crossing, figure and shape copying, line bisection and representational drawing (total score /146)
Measured: up to 6 weeks
Secondary outcomes (2)
Catherine Bergego Scale (CBS)
CBS for therapist (Bergego et al., 1995) is based on the direct observation of the therapist in ten standardised dailylife situations. The score ranges from 0 to 30 (higher scores indicating more severe neglect).
Measured: up to 6 weeks
Functional Independence Measure (FIM)
FIM (Minaire, 1991) is a basic indicator of patient disability. FIM is used to track the changes in the functional ability of a patient during an episode of hospital rehabilitation care.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start6 Sep 2017
- Primary completion5 Jan 2021
- Study completion1 Jul 2022
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
- Crossover
- Model description
- Each patient was assigned to a group who received 2 rehabilitations for 3 weeks, 1) both serious game training and a conventional rehabilitation first and then conventional rehabilitation alone (group 1, G1), or 2) a conventional rehabilitation first and then both serious game training and a conventional rehabilitation (group 2, G2).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 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
- NCT05805748
- Sponsor's protocol ID
- NSU-SG 5M
- Status last verified
- Apr 2023
- First submitted
- 27 Mar 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. 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
- NCT05805748
- Acronym / sponsor ID
- NSU-SG 5M
- Conditions
- Stroke, Unilateral Spatial Neglect
- Keywords
- rehabilitation, new technology, unilateral spatial neglect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hopitaux de Saint-MauriceUniversity, hospital or other
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 5 Jan 2021 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 10 Apr 2023 (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. Investigators developed a rehabilitation program for visual exploration training with a serious game and investigated its efficiency. Twelve patients with unilateral spatial neglect after a right hemispheric stroke were recruited. Six patients assigned to a group received both serious game training and conventional rehabilitation, and after only conventional rehabilitation; and six patients assigned to another group received first conventional rehabilitation and then serious game training and conventional rehabilitation. The investigators compared the two groups after rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Each patient was assigned to a group who received 2 rehabilitations for 3 weeks, 1) both serious game training and a conventional rehabilitation first and then conventional rehabilitation alone (group 1, G1), or 2) a conventional rehabilitation first and then both serious game training and a conventional rehabilitation (group 2, G2).
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Behavioral: serious game rehabilitationEach patient received 2 rehabilitations : a serious game training and a conventional rehabilitation first (during 3 weeks) and then conventional rehabilitation alone (during 3 weeks) |
| Group 2 | Active comparator | Behavioral: serious game rehabilitationEach patient received 2 rehabilitations for 3 weeks: a conventional rehabilitation first (during 3 weeks) and then both serious game training and a conventional rehabilitation (during 3 weeks) |
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 rehabilitationThe SG rehabilitation was proposed to be played four times per week for three weeks, for a total of 12 sessions, with 15 min per session (= 60 minutes per week). Conventional rehabilitation comprised five sessions of 45 min of neuropsychological rehabilitation using classical exploration training (= 225 minutes per week). | Behavioural | Group 1, Group 2 |
Primary outcome
Behavioral Inattention Test (BIT)
Time frame: up to 6 weeks
Behavioral Inattention Test (Wilson et al., 1987) (BIT) including the first part of conventional subtests: star and letter cancellation, line crossing, figure and shape copying, line bisection and representational drawing (total score /146)
2 secondary outcomes
Catherine Bergego Scale (CBS)
Time frame: up to 6 weeks
Functional Independence Measure (FIM)
Time frame: up to 6 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 10 Apr 2023.
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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.
1 site in 1 country: see every site and its status.
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 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 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 10 Apr 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 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?
Behavioral Inattention Test (BIT) (time frame: up to 6 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 10 Apr 2023.