StrokeNCT02315963
Feedback and Rewards to Increase Motivation for Therapy in Stroke Rehabilitation
A study testing Performance Feedback in people with Stroke, run by Cereneo AG at 1 site in Switzerland.
Trial summary
High motivation is a predictor for good therapy results in physical therapy [Grahn 2000]. The investigator want to show that it is possible to increase patients motivation for stroke rehabilitation by providing them objective performance feedback about the patients therapy progress. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Performance Feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2016to Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- First time Inpatient at the Cereneo rehabilitation clinic
Who cannot join
- Rey-Figur Kopie <= 25 AND Rechnerisches Denken WIE <=5
- Becks Depression Inventar (BDI) > 17
- Major aphasia preventing understanding of study materials (according to the treating physician).
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Cereneo, Center For Rehabilitation and Neurology
Vitznau, Canton of Lucerne, 6354
About this study
High motivation is a predictor for good therapy results in physical therapy [Grahn 2000]. The investigator want to show that it is possible to increase patients motivation for stroke rehabilitation by providing them objective performance feedback about the patients therapy progress.
Read the detailed description
High motivation is a predictor for good therapy results in physical therapy [Grahn 2000]. Additional focus on motivation and rewards has fallen on the topic of stroke rehabilitation since it was shown in an animal model that the brain centers involved with motivation and rewards are crucial to motor learning [Hosp 2011].
The investigators goal is to target the overall motivation for therapy. During the guided therapy sessions the therapists will be the main motivators and the investigators do not want to interfere with that. But the amount of guided therapy sessions is often limited due to economical reason rather than therapeutic ones. Therefore patients are encouraged to do training on their own if possible and to be active during the patients stay in the rehabilitation clinic. The investigators target the patients motivation to train by themselves and be active but also the patients attitude towards the guided therapies. It is known that performance feedback can improve motivation [Harackiewicz 1979]. Therefore the investigators want to use the data about therapy progress to produce feedback for patients visualizing the patients progress and efforts during the patients stay in the clinic.
The investigators will compare patients who receive normal therapy to patients who receive normal therapy plus performance feedback regarding a variety of motivation measures.
- Conditions
- Stroke
- Being tested
- Performance Feedback
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performance FeedbackOther
Performance Feedback regarding the patients efforts and accomplishments during the patients stay in the rehabilitation clinic, an expected average of 6 weeks. The data available about the patients progress will be analysed and processed to create a visual illustration shown to the patient on a daily bases.
| Study group | Role | What they receive |
|---|---|---|
| No intervention group | No intervention | Patients in stroke rehabilitation receiving standard therapy |
| Intervention group | Active comparator | Patients in stroke rehabilitation receiving standard therapy plus performance feedback Receives: Other: Performance Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motivation
Weekly: Intrinsic Motivation Inventory Questionnaire
Measured: Weekly for the duration of the participants stay at the hospital an expected average of 6 weeks
Motivation
Motivation rating of patients regarding the foregoing therapy session by therapists
Measured: After each therapy session for the duration of the participants stay at the hospital an expected average of 6 weeks
Motivation
Time patient spends on self administered training
Measured: Continuous for the duration of the participants stay at the hospital an expected average of 6 weeks
Motivation
Amount of activities (walking, stair climbing) during free time
Measured: Continuousfor the duration of the participants stay at the hospital an expected average of 6 weeks
Secondary outcomes (1)
Clinical scores (e.g. Fugl-Meyer Score)
Standard quality assessments of the study site (rehabilitation clinic)
Measured: When decided by therapists for the duration of the participants stay at the hospital an expected average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startApr 2016
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cereneo AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315963
- Sponsor's protocol ID
- KFSP Feedback Study
- Status last verified
- Jan 2021
- First submitted
- 8 Dec 2014
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Grahn B, Ekdahl C, Borgquist L. Motivation as a predictor of changes in quality of life and working ability in multidisciplinary rehabilitation. A two-year follow-up of a prospective controlled study in patients with prolonged musculoskeletal disorders. Disabil Rehabil. 2000 Oct 15;22(15):639-54. doi: 10.1080/096382800445443.
PubMed 11087060Hosp JA, Pekanovic A, Rioult-Pedotti MS, Luft AR. Dopaminergic projections from midbrain to primary motor cortex mediate motor skill learning. J Neurosci. 2011 Feb 16;31(7):2481-7. doi: 10.1523/JNEUROSCI.5411-10.2011.
PubMed 21325515Harackiewicz, Judith M. The effects of reward contingency and performance feedback on intrinsic motivation. Journal of Personality and Social Psychology, Vol 37(8), Aug 1979, 1352-1363.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feedback and Rewards to Increase Motivation for Therapy in Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT02315963
- Acronym / sponsor ID
- KFSP Feedback Study
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Cereneo AGIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 12 Dec 2014 (estimated)
- 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.
High motivation is a predictor for good therapy results in physical therapy [Grahn 2000]. The investigator want to show that it is possible to increase patients motivation for stroke rehabilitation by providing them objective performance feedback about the patients therapy progress.
Detailed description
High motivation is a predictor for good therapy results in physical therapy [Grahn 2000]. Additional focus on motivation and rewards has fallen on the topic of stroke rehabilitation since it was shown in an animal model that the brain centers involved with motivation and rewards are crucial to motor learning [Hosp 2011].
The investigators goal is to target the overall motivation for therapy. During the guided therapy sessions the therapists will be the main motivators and the investigators do not want to interfere with that. But the amount of guided therapy sessions is often limited due to economical reason rather than therapeutic ones. Therefore patients are encouraged to do training on their own if possible and to be active during the patients stay in the rehabilitation clinic. The investigators target the patients motivation to train by themselves and be active but also the patients attitude towards the guided therapies. It is known that performance feedback can improve motivation [Harackiewicz 1979]. Therefore the investigators want to use the data about therapy progress to produce feedback for patients visualizing the patients progress and efforts during the patients stay in the clinic.
The investigators will compare patients who receive normal therapy to patients who receive normal therapy plus performance feedback regarding a variety of motivation measures.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention group | No intervention | –Patients in stroke rehabilitation receiving standard therapy |
| Intervention group | Active comparator | Other: Performance FeedbackPatients in stroke rehabilitation receiving standard therapy plus performance feedback |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- First time Inpatient at the Cereneo rehabilitation clinic
Key exclusion criteria (3 listed)
- Rey-Figur Kopie <= 25 AND Rechnerisches Denken WIE <=5
- Becks Depression Inventar (BDI) > 17
- Major aphasia preventing understanding of study materials (according to the treating physician).
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 |
|---|---|---|
| Performance FeedbackPerformance Feedback regarding the patients efforts and accomplishments during the patients stay in the rehabilitation clinic, an expected average of 6 weeks. The data available about the patients progress will be analysed and processed to create a visual illustration shown to the patient on a daily bases. | Other | Intervention group |
Primary outcome
Motivation
Time frame: Weekly for the duration of the participants stay at the hospital an expected average of 6 weeks
Weekly: Intrinsic Motivation Inventory Questionnaire
Motivation
Time frame: After each therapy session for the duration of the participants stay at the hospital an expected average of 6 weeks
Motivation rating of patients regarding the foregoing therapy session by therapists
Motivation
Time frame: Continuous for the duration of the participants stay at the hospital an expected average of 6 weeks
Time patient spends on self administered training
Motivation
Time frame: Continuousfor the duration of the participants stay at the hospital an expected average of 6 weeks
Amount of activities (walking, stair climbing) during free time
1 secondary outcome
Clinical scores (e.g. Fugl-Meyer Score)
Time frame: When decided by therapists for the duration of the participants stay at the hospital an expected average of 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 1 Feb 2021.
- Background: PubMed 11087060Grahn B, Ekdahl C, Borgquist L. Motivation as a predictor of changes in quality of life and working ability in multidisciplinary rehabilitation. A two-year follow-up of a prospective controlled study in patients with prolonged musculoskeletal disorders. Disabil Rehabil. 2000 Oct 15;22(15):639-54. doi: 10.1080/096382800445443.
- Background: PubMed 21325515Hosp JA, Pekanovic A, Rioult-Pedotti MS, Luft AR. Dopaminergic projections from midbrain to primary motor cortex mediate motor skill learning. J Neurosci. 2011 Feb 16;31(7):2481-7. doi: 10.1523/JNEUROSCI.5411-10.2011.
- BackgroundHarackiewicz, Judith M. The effects of reward contingency and performance feedback on intrinsic motivation. Journal of Personality and Social Psychology, Vol 37(8), Aug 1979, 1352-1363.
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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 Performance Feedback in people with Stroke, run by Cereneo AG at 1 site in Switzerland.
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 1 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 1 Feb 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 Switzerland. 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?
Motivation (time frame: Weekly for the duration of the participants stay at the hospital an expected average of 6 weeks). The study lists 4 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 NCT02315963, which also lists 3 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 1 Feb 2021.