Plain English Summary
Background and study aims
A stroke occurs when the blood supply is cut off to the brain. A majority of stroke patients are affected by an impaired function of the upper extremity (upper body and arms). Numerous studies have indicated that there is a relationship between intensity and amount of training on the one hand and improvement of functions on the other hand. Usually, patients with a severe paresis (muscle weakness) of the upper extremity are treated with the ArmeoSpring exoskeleton during their inpatient rehabilitation. An exoskeleton is a frame that is put on the arm to help support the arm weight and help improve function. The aim of this study is to examine what happens when treatment time with this device is increased without investing additional personnel.
Who can participate?
Stroke patients aged 18 to 85
What does the study involve?
Participants receive 24 training sessions with the exoskeleton over four weeks. This is connected to a computer that offers virtual reality. The degree in which they can move their arm while in the exoskeleton is recorded.
What are the possible benefits and risks of participating?
Participants may benefit from improvements in motor function. The device is safe and has a certificate allowing to use it for patient treatment. There are no known risks.
Where is the study run from?
Kliniken Schmieder (Germany)
When is the study starting and how long is it expected to run for?
February 2016 to February 2017
Who is funding the study?
Kliniken Schmieder (Germany)
Who is the main contact?
Prof. Dr. Joachim Liepert
j.liepert@kliniken-schmieder.de
Trial website
Contact information
Type
Public
Primary contact
Prof Joachim Liepert
ORCID ID
Contact details
Kliniken Schmieder
Zum Tafelholz 8
Allensbach
78476
Germany
+49 7533 808 1236
j.liepert@kliniken-schmieder.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1-2016
Study information
Scientific title
Using an upper extremity exoskeleton for semi-autonomous exercise during inpatient neurological rehabilitation- a pilot study
Acronym
Study hypothesis
A self-contained robot-assisted training in addition to conventional inpatient rehabilitation is feasible.
Ethics approval
University of Constance, 21/04/2016
Study design
An interventional study with the ArmeoSpring exoskeleton used as a device for additional self-contained training in evenings and on weekends. The study explores feasibility and acceptance. It is single-centre because it is a pilot study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet. Contact: j.liepert@kliniken-schmieder.de
Condition
Stroke patients
Intervention
Participants receive self-contained training with the Armeo Spring exoskeleton over a period of four weeks with up to 24 treatment sessions.
The exoskeleton is connected to a computer that offers a variety of games in a virtual reality environment. For example, patients can paint a room, can grasp objects in a supermarket, can catch balls and so on. The degree to which the patients can move the arm while it is positioned in the exoskeleton is determined. Movements visible on the screen are adjusted to this individual level of performance.
There is no follow up.
Intervention type
Device
Phase
Drug names
Primary outcome measure
Feasibility (recording of side effects or adverse events) is measured using a structured interview once a week during the 4 weeks. Patients and supervisors are interviewed after the first, second, third and fourth week.
Secondary outcome measures
Acceptance is measured using the visual analogue scale at the end of the treatment period (after 4 weeks)
Motor function is measured using Wolf Motor Function Test at baseline and after 4 weeks of additional therapy.
Overall trial start date
02/02/2016
Overall trial end date
08/02/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Treatment in a neurological rehabilitation hospital for > 4 weeks
2. Stroke patients
3. Severe upper limb paresis
4. Ability to understand instructions and make own decisions
5. Aged 18-85 years old
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
10
Participant exclusion criteria
1. Unwillingness to participate
2. Inability to understand the instructions
Recruitment start date
02/05/2016
Recruitment end date
06/01/2017
Locations
Countries of recruitment
Germany
Trial participating centre
Kliniken Schmieder
Zum Tafelholz 8
Allensbach
78476
Germany
Funders
Funder type
Hospital/treatment centre
Funder name
Kliniken Schmieder
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We plan to publish data on feasibility, acceptance and changes of motor functions.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Joachim Liepert; email: j.liepert@kliniken-schmieder.de
Intention to publish date
12/08/2017
Participant level data
Available on request
Basic results (scientific)
Publication list