Brain IschemiaNCT02735460
Usability of Andago V2.0 in Gait Rehabilitation of Stroke Patients
A study testing Andago V2.0 in people with Brain Ischemia and Intracranial Haemorrhage, run by Rehaklinik Zihlschlacht AG at 1 site in Switzerland.
Trial summary
Andago V2.0 is a recently developed overground gait and balance training device. Many patients in neurorehabilitation suffer from gait disorders, most typically after stroke. Since pharmacological therapies are basically not available, neurorehabilitation plays an important role in the treatment of such patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Ischemia, Intracranial Haemorrhage
- What is being tested?
- Andago V2.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2016to 3 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent as documented by signature
- Primary diagnosis of cerebral infarction (ICD-10: I63.0-I63.9) or intracerebral haemorrhage (ICD-10: I61.0-I69.9) independent of its location, age or cause
- Gait disorder defined by a category of 1 to 3 on the Functional Ambulation Classification (FAC) (17)
- Age above 18 years
- Admission to Rehaklinik Zihlschlacht for in-patient neurorehabilitation
Who cannot join
- Inability of the participant to understand the informed consent or to follow the procedures of the study, e.g., due to language problems, psychiatric disorders, cognitive impairment or aphasia (item 9 of the National Institute of Health Stroke Scale (NIHSS) ≥2)
- Weight >135 kg
- Height >200 cm
- Bone fragility (e.g., non-consolidated fractures or osteotomies including craniotomies, osteopenia, osteoporosis or symptoms or indices in the patient history that infer a higher risk of bone density reduction)
- Unstable arthroplasty
- Uncontrolled knee or ankle instability that would still pose a danger despite the Body Weight Support (BWS) (especially lateral instability)
Show all 17Show fewer
- Lack of head control
- Joint contractures
- Relevant differences in leg length
- Skin lesions (including pressure sores or enteric stomata) in areas of contact with harness support or lower extremity loading (feet)
- Relevant sensory impairment in the lower limbs and trunk, especially with reduced pain sensation
- Recent history or significant risk of seizures
- Relevant cardiovascular conditions, e.g., cardiac insufficiency and thoracotomy, uncontrolled orthostatic hypotension or other circulatory problems, vascular disorders of the lower limbs
- Mechanical ventilation
- Long-term infusions (e.g., baclofen pump, other intrathecal pumps)
- Any medical condition preventing active rehabilitation and/or the use of the Andago V2.0 (e.g., respiratory disease, pregnancy, orthopedic conditions, infections or inflammatory disorders, osteomyelitis)
- Participation in another interventional study within the 30 days preceding and during the present study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Rehaklinik Zihlschlacht, Center for Neurological Rehabilitation
Zihlschlacht
About this study
Official title: Single-center Usability Study of the Overground Gait and Balance Training Device Andago V2.0 in Patients With Gait Disorder After Stroke at a Center for Neurological Rehabilitation
Andago V2.0 is a recently developed overground gait and balance training device. Many patients in neurorehabilitation suffer from gait disorders, most typically after stroke. Since pharmacological therapies are basically not available, neurorehabilitation plays an important role in the treatment of such patients. The Andago V2.0 may represent a useful device in the rehabilitation of stroke and other neurological patients featuring a severe gait disorder. Therefore a study has been designed to investigate the usability of the Andago V2.0 in the setting of a neurorehabilitation clinic. The primary outcomes of this study are the usability and acceptance of the investigational medical device (IMD). Usability is mainly measured by the time spent for the set-up and release of the participant, achieved training times and distances, the number of stumbles, collisions and emergency stops and the error messages during the session. Besides patient and therapist satisfaction with the Andago V2.0 is recorded.
- Conditions
- Brain Ischemia, Intracranial Haemorrhage
- Being tested
- Andago V2.0
- Medical subject headings
- Brain Ischemia, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Andago V2.0Device
The Andago V2.0 is tested in 2 sessions, the first being a training session to define the probably optimal settings for the subsequent therapy session. In the therapy session the participant performs a specific parcours. Usually this parcours can be done within 10 minutes. However, the session is stopped as soon as the patient feels too exhausted or becomes too weary.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | In this arm the Andago V2.0 is used. Receives: Device: Andago V2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of the IMD according to the number of participants that are able to use the Andago V2.0
Measured: 3 weeks
Acceptance of the IMD as measured by a therapist satisfaction questionnaire
Measured: 3 weeks
Acceptance of the IMD as measured by a patient satisfaction questionnaire
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startMar 2016
- Primary completion3 Feb 2017
- Study completion3 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain IschemiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rehaklinik Zihlschlacht AG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Detlef Marks, Principal investigator, Rehaklinik Zihlschlacht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735460
- Sponsor's protocol ID
- RZI_01_2015
- Status last verified
- Sep 2018
- First submitted
- 15 Mar 2016
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Usability Study of the Overground Gait and Balance Training Device Andago V2.0 in Patients With Gait Disorder After Stroke at a Center for Neurological Rehabilitation
- ClinicalTrials.gov ID
- NCT02735460
- Acronym / sponsor ID
- RZI_01_2015
- Conditions
- Brain Ischemia, Intracranial Haemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Rehaklinik Zihlschlacht AGUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 3 Feb 2017 (actual)
- Study completion
- 3 Feb 2017 (actual)
- First posted
- 12 Apr 2016 (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.
Andago V2.0 is a recently developed overground gait and balance training device. Many patients in neurorehabilitation suffer from gait disorders, most typically after stroke. Since pharmacological therapies are basically not available, neurorehabilitation plays an important role in the treatment of such patients. The Andago V2.0 may represent a useful device in the rehabilitation of stroke and other neurological patients featuring a severe gait disorder. Therefore a study has been designed to investigate the usability of the Andago V2.0 in the setting of a neurorehabilitation clinic. The primary outcomes of this study are the usability and acceptance of the investigational medical device (IMD). Usability is mainly measured by the time spent for the set-up and release of the participant, achieved training times and distances, the number of stumbles, collisions and emergency stops and the error messages during the session. Besides patient and therapist satisfaction with the Andago V2.0 is recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: Andago V2.0In this arm the Andago V2.0 is used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent as documented by signature
- Primary diagnosis of cerebral infarction (ICD-10: I63.0-I63.9) or intracerebral haemorrhage (ICD-10: I61.0-I69.9) independent of its location, age or cause
- Gait disorder defined by a category of 1 to 3 on the Functional Ambulation Classification (FAC) (17)
- Age above 18 years
- Admission to Rehaklinik Zihlschlacht for in-patient neurorehabilitation
Key exclusion criteria (17 listed)
- Inability of the participant to understand the informed consent or to follow the procedures of the study, e.g., due to language problems, psychiatric disorders, cognitive impairment or aphasia (item 9 of the National Institute of Health Stroke Scale (NIHSS) ≥2)
- Weight >135 kg
- Height >200 cm
- Bone fragility (e.g., non-consolidated fractures or osteotomies including craniotomies, osteopenia, osteoporosis or symptoms or indices in the patient history that infer a higher risk of bone density reduction)
- Unstable arthroplasty
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 |
|---|---|---|
| Andago V2.0The Andago V2.0 is tested in 2 sessions, the first being a training session to define the probably optimal settings for the subsequent therapy session. In the therapy session the participant performs a specific parcours. Usually this parcours can be done within 10 minutes. However, the session is stopped as soon as the patient feels too exhausted or becomes too weary. | Device | Treatment arm |
Primary outcome
Usability of the IMD according to the number of participants that are able to use the Andago V2.0
Time frame: 3 weeks
Acceptance of the IMD as measured by a therapist satisfaction questionnaire
Time frame: 3 weeks
Acceptance of the IMD as measured by a patient satisfaction questionnaire
Time frame: 3 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 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Detlef Marks principal investigator
Rehaklinik Zihlschlacht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Andago V2.0 in people with Brain Ischemia and Intracranial Haemorrhage, run by Rehaklinik Zihlschlacht 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 5 inclusion and 17 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 Oct 2018. 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?
Usability of the IMD according to the number of participants that are able to use the Andago V2.0 (time frame: 3 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?
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 Oct 2018.