Robot-aided Arm Therapy, Brain Injury, Motor Relearning Programme, Activities of Daily LivingNCT02434237
Robot-Aided Neurorehabilitation of the Upper Extremities
An observational study of Robot-aided Arm Therapy, Brain Injury, Motor Relearning Programme, Activities of Daily Living, run by University of Zurich at 1 site in Switzerland.
Trial summary
Task-oriented repetitive movement can improve movement performance in patients with neurological or orthopedic lesions. The application of robotics can serve to assist, enhance, evaluate, and document neurological and orthopedic rehabilitation of movements. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Robot-aided Arm Therapy, Brain Injury, Motor Relearning Programme, Activities of Daily Living
- How many people
- 45 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2005to Mar 2015
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects and neurological patients after stoke or spinal cord injury
Who may be able to join
- Patients with neurological disability of the upper limb with qualification for arm training, e.g. after stroke and spinal cord injury
Who cannot join
- limitations of the join mobility
- osteoporosis
- cardiovascular disease
- injury of the upper limb
- decubitus
- psychic diseases (like schizophrenia, dementia, depression)
- Body weight > 120kg
- pacemaker.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Zurich, Swiss Federal Institute of Technology
Zurich, Canton of Zurich, 8008
About this study
Task-oriented repetitive movement can improve movement performance in patients with neurological or orthopedic lesions. The application of robotics can serve to assist, enhance, evaluate, and document neurological and orthopedic rehabilitation of movements. Arm therapy is used in neurological rehabilitation for patients with paralyzed upper extremities due to lesions of the central or peripheral nervous system, e.g. after stroke or spinal cord injury. The goal of the therapy is to recover motor function, improve movement coordination, learn new motion strategies ("trick movements"), and/or prevent secondary complications such as muscle atrophy, osteoporosis, and spasticity.
- Conditions
- Robot-aided Arm Therapy, Brain Injury, Motor Relearning Programme, Activities of Daily Living
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients | Not described | |
| healthy subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The acceptanece of the arm rehabilitation robot therapy and the influence to the motivation through the visual feedback.
Measured: A measure lasts approx. 90 minutes. Every participant once.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startMar 2005
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robot-aided Arm Therapy, Brain Injury, Motor Relearning Programme, Activities of Daily LivingStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434237
- Sponsor's protocol ID
- EK 04 2005
- Status last verified
- Apr 2015
- First submitted
- 13 Oct 2014
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-Aided Neurorehabilitation of the Upper Extremities
- ClinicalTrials.gov ID
- NCT02434237
- Acronym / sponsor ID
- EK 04 2005
- Conditions
- Robot-aided Arm Therapy, Brain Injury, Motor Relearning Programme, Activities of Daily Living
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 5 May 2015 (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.
Task-oriented repetitive movement can improve movement performance in patients with neurological or orthopedic lesions. The application of robotics can serve to assist, enhance, evaluate, and document neurological and orthopedic rehabilitation of movements. Arm therapy is used in neurological rehabilitation for patients with paralyzed upper extremities due to lesions of the central or peripheral nervous system, e.g. after stroke or spinal cord injury. The goal of the therapy is to recover motor function, improve movement coordination, learn new motion strategies ("trick movements"), and/or prevent secondary complications such as muscle atrophy, osteoporosis, and spasticity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | – | – |
| healthy subjects | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects and neurological patients after stoke or spinal cord injury
Key inclusion criteria (1 listed)
- Patients with neurological disability of the upper limb with qualification for arm training, e.g. after stroke and spinal cord injury
Key exclusion criteria (8 listed)
- limitations of the join mobility
- osteoporosis
- cardiovascular disease
- injury of the upper limb
- decubitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The acceptanece of the arm rehabilitation robot therapy and the influence to the motivation through the visual feedback.
Time frame: A measure lasts approx. 90 minutes. Every participant once.
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 5 May 2015.
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?
An observational study of Robot-aided Arm Therapy, Brain Injury, Motor Relearning Programme, Activities of Daily Living, run by University of Zurich 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 8 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 5 May 2015. 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?
The acceptanece of the arm rehabilitation robot therapy and the influence to the motivation through the visual feedback. (time frame: A measure lasts approx. 90 minutes. Every participant once.). 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 5 May 2015.