Condition category
Nervous System Diseases
Date applied
23/07/2017
Date assigned
02/08/2017
Last edited
01/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Kliniken Schmieder

Sponsor details

Zum Tafelholz 8
Allensbach
78476
Germany

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes