StrokeNCT03268304
Feasibility of Two New Software Modules for the Rehabilitation of Patients With Neuromuscular Upper Limb Impairments
An observational study of Stroke and Parkinson Disease, run by Reha Rheinfelden.
Trial summary
Introduction: In the recent past, medical training systems using virtual reality (VR) have been introduced to neurorehabilitation to train motor function deficits in patients. The usage of VR-based training systems is based on the evidence of neuroplasticity, which is responsible for recovery of patients suffering… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Parkinson Disease, Traumatic Brain Injury
- What is being tested?
- VR-based training including AO and MI
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2018to 30 May 2020
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: 1. Patients will be recruited from the clinics' inpatient or outpatient departments by physicians, therapists and nurses. 2. Patients will be recruited from the clinics' patient database. Datasets will be screened for study selection criteria by the involved study personnel. If patients are eligible, they will be sent a letter describing the study and including patient information. If patients are interested in participating, they can contact the study personnel in the clinic by phone or email. 3. Patients will be recruited via a study information flyer provided on the clinic's homepage and through patient self-help groups. If patients are interested in participating, they can contact the study personnel in the responsible clinic by phone or email.
Who may be able to join
- Patients with motor function impairments of one or both upper limbs caused by Parkinson's disease, MS, Stroke, traumatic brain injury or Guillain-Barré syndrome
- Able to sit in a normal chair without armrests
- Able to score at least one in the Box and Block Test (BBT)
- Comprehend German
- Informed Consent as documented by signature
Who cannot join
- Wrist-, hand- or finger contractures or an unconsolidated upper limb fracture
- Severe cognitive deficits: Mini-Mental-Status-Test (MMSE) ≤ 20
- Severe spatial-visual disorders, e.g. severe visual neglect
- History of epileptic seizures triggered by visual stimuli (e.g. television, video games) within the last six months
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- Full score in the Chedoke Arm and Hand Activity Inventory (CAHAI) assessment
- Brain pacemaker
About this study
Official title: Feasibility of Two Novel Interactive Software Modules for the Rehabilitation of Patients With Neuromuscular Upper Limb Impairments Using the YouGrabber Training System - the KAYO Study Protocol
Introduction: In the recent past, medical training systems using virtual reality (VR) have been introduced to neurorehabilitation to train motor function deficits in patients. The usage of VR-based training systems is based on the evidence of neuroplasticity, which is responsible for recovery of patients suffering from motor dysfunction. Such systems are increasingly used to encourage purposeful limb movements in a VR environment and its efficacy has been found comparable with conventional therapeutic intervention. VR training systems, e.g. the YouGrabber® (YG), will increasingly also be used at home. Therefore, it is essential to integrate valid and reliable assessment tools to monitor the recovery process.
Objectives: The aim of the clinical study is to evaluate the usability, feasibility and validity of the digital version of the ActionResearchArmTest (d-ARAT) using the YG system as a platform. Additionally, the feasibility and usability of the implementation of two rehabilitation measures that only recently became integral part of neurorehabilitation, e.g. Action Observation (AO) and Motor Imagery (MI), into the YG training software will be evaluated. Patients \& methods: This observational study is designed as a single-arm trial for testing the assessment software including pre- to post rehabilitation comparison of a training involving AO and MI. Therefore, 75 adult patients with Parkinson's disease, MS, Stroke, traumatic brain injury or Guillain-Barré syndrome will be included. 30 out of the 75 patients will take part in the 4-week training on the enhanced VR-based system with a total of 16 training sessions of 45 min each. Primary outcomes will be the score on the System Usability Scale (SUS) and the ARAT as well as the d-ARAT scores. Secondary outcomes will be hand dexterity (Box-and-Block Test), upper limb activities of daily living (CAHAI) and quality of life (EQ-5D-5L).
Hypothesis: The study was designed to evaluate the d-ARAT and the training software modules for the YG system. Currently AO and MI specific tasks are being integrated and the ARAT subscales will be implemented on the basis of the redesigned glove equipped with new sensors. The results are expected to give recommendations for necessary modifications. They might also contribute knowledge concerning the application of AO and MI tasks within VR training.
- Being tested
- VR-based training including AO and MI
- Keywords
- Upper Limb Motor Function Deficit, Neurorehabilitation, Virtual Reality, Action Research Arm Test
- Medical subject headings
- Stroke, Parkinson Disease, Brain Injuries, Traumatic, Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-based training including AO and MIOther
Virtual Reality-based training intervention including Action Observation and Motor Imagery using the YouGrabber® training device
What is being measured
The primary outcome is the main question the study is designed to answer.
cARAT
Score on the conventional Action Research Arm Test
Measured: 17 weeks
dARAT
score on the digital ARAT
Measured: 17 weeks
SUS
System Usability Scale questionnaire
Measured: 15 weeks
Secondary outcomes (4)
BBT
Box and Block Test
Measured: 17 weeks
CAHAI
Chedoke McMaster Arm and Hand Activity Inventory
Measured: 17 weeks
EQ-5D-5L
EuroQol five dimensions questionnaire with five-level scale
Measured: 17 weeks
PGIC
Patient Global Impression of change
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start1 Nov 2018
- Primary completion1 Apr 2020
- Study completion30 May 2020 (estimated)
Why it stopped: The software modules were not completed.
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reha Rheinfelden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Behrendt, Reha Rheinfelden
- Investigators
- Frank Behrendt, PhD, Principal investigator, Reha RheinfeldenCorina Schuster, PhD, Principal investigator, Reha Rheinfelden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268304
- Sponsor's protocol ID
- KAYO
- Status last verified
- Apr 2020
- First submitted
- 29 Aug 2017
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Behrendt F, Schuster-Amft C. Using an interactive virtual environment to integrate a digital Action Research Arm Test, motor imagery and action observation to assess and improve upper limb motor function in patients with neuromuscular impairments: a usability and feasibility study protocol. BMJ Open. 2018 Jul 16;8(7):e019646. doi: 10.1136/bmjopen-2017-019646.
PubMed 30012780
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Two Novel Interactive Software Modules for the Rehabilitation of Patients With Neuromuscular Upper Limb Impairments Using the YouGrabber Training System - the KAYO Study Protocol
- ClinicalTrials.gov ID
- NCT03268304
- Acronym / sponsor ID
- KAYO
- Keywords
- Upper Limb Motor Function Deficit, Neurorehabilitation, Virtual Reality, Action Research Arm Test
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The software modules were not completed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Reha RheinfeldenUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 30 May 2020 (estimated)
- First posted
- 31 Aug 2017 (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.
Introduction: In the recent past, medical training systems using virtual reality (VR) have been introduced to neurorehabilitation to train motor function deficits in patients. The usage of VR-based training systems is based on the evidence of neuroplasticity, which is responsible for recovery of patients suffering from motor dysfunction. Such systems are increasingly used to encourage purposeful limb movements in a VR environment and its efficacy has been found comparable with conventional therapeutic intervention. VR training systems, e.g. the YouGrabber® (YG), will increasingly also be used at home. Therefore, it is essential to integrate valid and reliable assessment tools to monitor the recovery process.
Objectives: The aim of the clinical study is to evaluate the usability, feasibility and validity of the digital version of the ActionResearchArmTest (d-ARAT) using the YG system as a platform. Additionally, the feasibility and usability of the implementation of two rehabilitation measures that only recently became integral part of neurorehabilitation, e.g. Action Observation (AO) and Motor Imagery (MI), into the YG training software will be evaluated. Patients \& methods: This observational study is designed as a single-arm trial for testing the assessment software including pre- to post rehabilitation comparison of a training involving AO and MI. Therefore, 75 adult patients with Parkinson's disease, MS, Stroke, traumatic brain injury or Guillain-Barré syndrome will be included. 30 out of the 75 patients will take part in the 4-week training on the enhanced VR-based system with a total of 16 training sessions of 45 min each. Primary outcomes will be the score on the System Usability Scale (SUS) and the ARAT as well as the d-ARAT scores. Secondary outcomes will be hand dexterity (Box-and-Block Test), upper limb activities of daily living (CAHAI) and quality of life (EQ-5D-5L).
Hypothesis: The study was designed to evaluate the d-ARAT and the training software modules for the YG system. Currently AO and MI specific tasks are being integrated and the ARAT subscales will be implemented on the basis of the redesigned glove equipped with new sensors. The results are expected to give recommendations for necessary modifications. They might also contribute knowledge concerning the application of AO and MI tasks within VR training.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 1. Patients will be recruited from the clinics' inpatient or outpatient departments by physicians, therapists and nurses. 2. Patients will be recruited from the clinics' patient database. Datasets will be screened for study selection criteria by the involved study personnel. If patients are eligible, they will be sent a letter describing the study and including patient information. If patients are interested in participating, they can contact the study personnel in the clinic by phone or email. 3. Patients will be recruited via a study information flyer provided on the clinic's homepage and through patient self-help groups. If patients are interested in participating, they can contact the study personnel in the responsible clinic by phone or email.
Key inclusion criteria (5 listed)
- Patients with motor function impairments of one or both upper limbs caused by Parkinson's disease, MS, Stroke, traumatic brain injury or Guillain-Barré syndrome
- Able to sit in a normal chair without armrests
- Able to score at least one in the Box and Block Test (BBT)
- Comprehend German
- Informed Consent as documented by signature
Key exclusion criteria (7 listed)
- Wrist-, hand- or finger contractures or an unconsolidated upper limb fracture
- Severe cognitive deficits: Mini-Mental-Status-Test (MMSE) ≤ 20
- Severe spatial-visual disorders, e.g. severe visual neglect
- History of epileptic seizures triggered by visual stimuli (e.g. television, video games) within the last six months
- Enrolment of the investigator, his/her family members, employees and other dependent persons
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 |
|---|---|---|
| VR-based training including AO and MIVirtual Reality-based training intervention including Action Observation and Motor Imagery using the YouGrabber® training device | Other | – |
Primary outcome
cARAT
Time frame: 17 weeks
Score on the conventional Action Research Arm Test
dARAT
Time frame: 17 weeks
score on the digital ARAT
SUS
Time frame: 15 weeks
System Usability Scale questionnaire
4 secondary outcomes
BBT
Time frame: 17 weeks
CAHAI
Time frame: 17 weeks
EQ-5D-5L
Time frame: 17 weeks
PGIC
Time frame: 11 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Derived from this study: PubMed 30012780Behrendt F, Schuster-Amft C. Using an interactive virtual environment to integrate a digital Action Research Arm Test, motor imagery and action observation to assess and improve upper limb motor function in patients with neuromuscular impairments: a usability and feasibility study protocol. BMJ Open. 2018 Jul 16;8(7):e019646. doi: 10.1136/bmjopen-2017-019646.
- Individual participant dataSharing planned: Undecided
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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.
Frank Behrendt, PhD principal investigator
Reha Rheinfelden
Corina Schuster, PhD principal investigator
Reha Rheinfelden
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Parkinson Disease, run by Reha Rheinfelden.
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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 21 Apr 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
cARAT (time frame: 17 weeks). The study lists 3 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 NCT03268304, 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 21 Apr 2020.