Spinal Cord InjuriesLEAPNCT03458169

LEAP a New Overground Body Weight Support Robot: Usability Trial

A study testing Therapist LEAP session feedback and Participant LEAP session feedback in people with Spinal Cord Injuries and Cerebral Palsy, run by Clinique Romande de Readaptation at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 5 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Spinal Cord Injuries, Cerebral Palsy, Parkinson Disease
What is being tested?: Therapist LEAP session feedback and Participant LEAP session feedback
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteSwitzerland
Study dates: 1 Jan 2018to 30 Apr 2018
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 5 to 80 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Healthy participants fulfilling all of the following inclusion criteria are eligible for the study:

The healthy volunteer or legal representative has been informed and has signed the informed consent form
Age 18-80 or age 5-10 (women or men)
Weight below 137 kg
Height between 120 and 190 cm
Agree to comply in good faith with all conditions of the study and to attend all required training

Patients fulfilling all of the following inclusion criteria are eligible for the study:

The patient has been informed and has signed the informed consent form
Age 18-80 (women or men)
Weight below 137 kg
Height between 120 and 190 cm
Neurological/musculoskeletal diagnoses
Impairment of the lower extremities
Stable medical and physical condition as considered by the attending doctor or physician
Agree to comply in good faith with all conditions of the study and to attend all required training
Other (non-neurological) diagnoses, who require intense training of the lower extremities
The rehabilitation physician or doctor provides a final agreement whether the participant can train with the LEAP

The presence of any one of the following exclusion criteria will lead to exclusion of the participant, for example:

Strong adipositas, which makes it not possible to adjust the harness to the anthropometrics of the participant
Bracing of the spinal column.
Severe joint contractures disabling or restricting lower limb movements
Instabilities of bones or joints, fractures or osteoporosis/osteopenia
Allergy against material of harness
Open skin lesions
Luxations or subluxations of joints that should be positioned in LEAP
Strong pain
Strong spontaneous movements like ataxia, dyskinesia, myoclonus*
Instable vital functions like pulmonal or cardiovascular conditions
Uncooperative or aggressive behaviour
Severe cognitive deficits
Inability to signal pain or discomfort
Apraxia*
Severe spasticity (Ashworth 4)
Severe epilepsy*
Insufficient head stability
Infections requiring isolation of the patient
History of significant autonomic dysreflexia
Systemic malignant disorders
Cardiovascular disorders restricting physical training
Peripheral nerve disorders
Other anatomic or co-morbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results.
Known or suspected non-compliance, drug or alcohol abuse,
Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
Participation in another study with investigational drug within the 30 days preceding and during the present study
Previous enrolment into the current study Contraindications marked with an * are relative contraindications. Final approval needs to be obtained from the attending medical doctor.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Clinique Romande de Réadaptation (CRR), SUVAcare
Sion, Valais, 1951

Other trials in Switzerland

About this study

Official title: Usability of a New Overground Body Weight Support Rehabilitation Robot LEAP: A Monocentric Consideration-of-concept Trial

People with central nervous system disorders such as spinal cord injury, stroke, cerebral palsy, Parkinson's disease, multiple sclerosis, etc… often have impaired lower extremity function that limits activities of daily life and independence. Different body-weight support systems have been developed to facilitate the rehabilitation process by compensating for the user's residual abilities. However, studies on weight-supported gait training on a treadmill have failed to show superiority over conventional rehabilitation programs for spinal cord injury and stroke. A recent study by the group around Grégoire Courtine showed that body-weight support systems that provide assistance only in the vertical direction disrupt the production of gait and balance, suggesting that current practices may even be detrimental for relearning to walk. For the past year, the Clinique Romande de Réadaptation (CRR) worked together with the G-Lab at EPFL and G-Therapeutics on a new robot platform specifically developed to provide adjustable trunk support along four independent degrees of freedom (LEAP). The investigators were able to draw on their long-term experience, which consists of different body weight support training systems for stroke and spinal cord injury. This knowledge, combined with the input of our therapists and physicians and the specific requirements for people with neurological/musculoskeletal disorders, has resulted in a design that can provide adjustable bodyweight support during over-ground locomotion, treadmill, stairs training, standing up and sitting down and for support during the training of activities of daily living.

The scope of this study is to examine how well the robot can be used for rehabilitation therapy in everyday clinical practice. This includes, among other things, technical aspects such as the handling of the hardware, the adaptability of the robot to the patient, and the safety during operation (such as the fall prevention). Various patient-specific aspects will also be evaluated e.g. comfort, positioning, or motivation of the patient. This study also aims to evaluate the software with the various support modes, operating options, and the user interface of the LEAP.

Conditions: Spinal Cord Injuries, Cerebral Palsy, Parkinson Disease, Multiple Sclerosis, Stroke, People With Impaired Lower Extremity Function
Being tested: Therapist LEAP session feedback, Participant LEAP session feedback, LEAP risk control validation
Medical subject headings: Spinal Cord Injuries, Cerebral Palsy, Parkinson Disease, Multiple Sclerosis, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Therapist LEAP session feedbackDevice
A standard therapy session is being performed with a participant with the LEAP body-weight support robot. Subsequently, the therapist is answering a questionnaire to assess the clinical applicability of the robot. An observer will assess with a questionnaire whether use errors occurred during the session.
Participant LEAP session feedbackDevice
A standard therapy session is being performed with a participant inside the LEAP body-weight support robot. Subsequently, the participant is answering a questionnaire to assess the comfort of the robot.
LEAP risk control validationDevice
The therapist rates the risk control measurements of the LEAP robot with a questionnaire, during a session with a member of the investigational team.

Study groups in NCT03458169
Study group	Role	What they receive
LEAP usability	Experimental	* Therapist LEAP session feedback * Participant LEAP session feedback * LEAP risk control validation Receives: Device: Therapist LEAP session feedback; Device: Participant LEAP session feedback; Device: LEAP risk control validation

What is being measured

The primary outcome is the main question the study is designed to answer.

Usability of the robot - Fixation
From the user/therapist the information on the usability of the robot (CRF I) is being assessed. This questionnaire is only filled once by each user/therapist.
Feedback on patient/subject fixation (Ordinal scale from 1:useful to 5:not useful)
Measured: 2 minutes
Usability of the robot - Applicability
From the user/therapist the information on the usability of the robot (CRF I) is being assessed. This questionnaire is only filled once by each user/therapist.
Feedback on clinical applicability (Ordinal scale from 1:useful to 5:not useful)
Measured: 2 minutes
Usability of the robot - Robot support
From the user/therapist the information on the usability of the robot (CRF I) is being assessed. This questionnaire is only filled once by each user/therapist.
Feedback on robot support (Ordinal scale from 1:useful to 5:not useful)
Measured: 2 minutes
Usability of the robot - User interface
From the user/therapist the information on the usability of the robot (CRF I) is being assessed. This questionnaire is only filled once by each user/therapist.
Feedback on user interface (Graphical user interface) (Ordinal scale from 1:useful to 5:not useful)
Measured: 2 minutes
Usability of the robot - Interaction
From the user/therapist the information on the usability of the robot (CRF I) is being assessed. This questionnaire is only filled once by each user/therapist.
Feedback on the LEAP interaction (Ordinal scale from 1:useful to 5:not useful)
Measured: 2 minutes
Risk control validation - Observer
From an independent observer (investigator, or a member of the development team) the occurrence of use errors is recorded (CRF III):
Each primary operating function of the robot is rated (Ordinal scale from 0 to 1 for 'use error occurred' or 'no use error' This questionnaire has only to be filled out once for each user/therapist.
Measured: 1 hour
Risk control validation - User
The risk control measures are validated by the user/therapist (CRF IV):
The different risk controls are rated (Ordinal scale from 0 to 1 for 'Acceptable' or 'Not acceptable') This questionnaire has only to be filled out once by each user/therapist.
Measured: 1 hour
Participant feeling of safety/comfort - Fixation
From the participant information on the comfort/safety is being assessed (CRF II):
Feedback on the fixation of the patient (Open-ended question)
Measured: 1 minute
Participant feeling of safety/comfort - Robot training
From the participant information on the comfort/safety is being assessed (CRF II):
Feedback on the robot training (Ordinal scale from 0 to 5)
Measured: 1 minute
Participant feeling of safety/comfort - Robot support
From the participant information on the comfort/safety is being assessed (CRF II):
Feedback on the robot support (Ordinal scale from 0 to 5)
Measured: 1 minute

Secondary outcomes (21)

Robot Measurement - Patient position
The robot records the patient position in the room (in meters).
Measured: 1 hour
Robot Measurement - Walking speed
The robot records the walking speed (in meters per second).
Measured: 1 hour
Robot Measurement - Occurred errors
The robot records the errors occurred (error number).
Measured: 1 hour
Robot Measurement - Support forces
The robot records the support forces (in Newton).
Measured: 1 hour
Robot Measurement - Fall detection
The robot records the number of detected falls (Amount of detected falls).
Measured: 1 hour
Robot Measurement - Walked distance
The robot records the distance the patient walked during the session (in meters).
Measured: 1 hour
EMG system
Upon availability, an EMG system will be used to measure muscle activity during the session.
Measured: 1 hour
Patient characteristics - Testing date
The testing date (day/month/year) is being recorded.
Measured: 1 minutes
Patient characteristics - Identification number
A unique participant identification number is being recorded.
Measured: 1 minutes
Patient characteristics - Body height
The body height (in cm) is being recorded.
Measured: 1 minutes
Patient characteristics - Body weight
The body weight (in kg) is being recorded.
Measured: 1 minutes
Patient characteristics - Waist size
The waist size (in cm) is being recorded.
Measured: 1 minutes
Patient characteristics - Tight circumference
The tight circumference (in cm) is being recorded.
Measured: 1 minutes
Patient characteristics - Chest size
The chest size (in cm) is being recorded.
Measured: 1 minutes
Patient characteristics - Age
The following patient characteristic is being transferred from the clinical internal database (obtained in the CRR on a regular basis): The age of the participant (in years, decimal) is being recorded.
Measured: 1 minutes
Patient characteristics - Stationary or ambulant
The following patient characteristic is being transferred from the clinical internal database (obtained in the CRR on a regular basis): It will be recorded whether the patient is stationary or ambulant.
Measured: 1 minutes
Patient characteristics - Dominant side
The following patient characteristic is being transferred from the clinical internal database (obtained in the CRR on a regular basis): The dominant body side (left or right) is being recorded.
Measured: 1 minutes
Patient characteristics - Walking aid
The following patient characteristic is being transferred from the clinical internal database (obtained in the CRR on a regular basis):
If applicable: The type of walking aid (open-ended question) is being recorded.
Measured: 1 minutes
Patient characteristics - Six minute walking test
The following patient characteristic is being transferred from the clinical internal database (obtained in the CRR on a regular basis): Upon availability the outcome of the Six-minute walking test will be recorded (distance in meters. Longer distance corresponds to a better outcome.).
Measured: 1 minutes
Patient characteristics - BAECKE score
The following patient characteristic is being transferred from the clinical internal database (obtained in the CRR on a regular basis): BAECKE physical activity questionnaire (Score between 0: no activity, and 10: high activity).
Measured: 1 minutes
Patient characteristics - Fugl-Meyer score
The following patient characteristic is being transferred from the clinical internal database (obtained in the CRR on a regular basis): Lower limb subset of the Fugl-Meyer score. Fugl-Meyer assessment measures the sensorimotor function. (Score between 0: no function and 34: full functionality).
Measured: 1 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201830 Apr 2018

First posted8 Mar 2018
Study start1 Jan 2018
Primary completion30 Apr 2018
Study completion30 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (40)Papers the sponsor has linked to this study.
Other trials for Spinal Cord InjuriesStudies 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03458169
Sponsor's protocol ID: CliniqueRR-05
Acronym: LEAP
Status last verified: Mar 2018
First submitted: 21 Dec 2017
Last updated: 30 Jan 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Freund P, Weiskopf N, Ward NS, Hutton C, Gall A, Ciccarelli O, Craggs M, Friston K, Thompson AJ. Disability, atrophy and cortical reorganization following spinal cord injury. Brain. 2011 Jun;134(Pt 6):1610-22. doi: 10.1093/brain/awr093. Epub 2011 May 17.
PubMed 21586596
Kennedy P, Rogers BA. Anxiety and depression after spinal cord injury: a longitudinal analysis. Arch Phys Med Rehabil. 2000 Jul;81(7):932-7. doi: 10.1053/apmr.2000.5580.
PubMed 10896007
Fehr L, Langbein WE, Skaar SB. Adequacy of power wheelchair control interfaces for persons with severe disabilities: a clinical survey. J Rehabil Res Dev. 2000 May-Jun;37(3):353-60.
PubMed 10917267
Hunt PC, Boninger ML, Cooper RA, Zafonte RD, Fitzgerald SG, Schmeler MR. Demographic and socioeconomic factors associated with disparity in wheelchair customizability among people with traumatic spinal cord injury. Arch Phys Med Rehabil. 2004 Nov;85(11):1859-64. doi: 10.1016/j.apmr.2004.07.347.
PubMed 15520982
Meyns P, Van de Crommert HW, Rijken H, van Kuppevelt DH, Duysens J. Locomotor training with body weight support in SCI: EMG improvement is more optimally expressed at a low testing speed. Spinal Cord. 2014 Dec;52(12):887-93. doi: 10.1038/sc.2014.172. Epub 2014 Oct 14.
PubMed 25311847
Crompton S, Khemlani M, Batty J, Ada L, Dean C, Katrak P. Practical issues in retraining walking in severely disabled patients using treadmill and harness support systems. Aust J Physiother. 2001;47(3):211-3. doi: 10.1016/s0004-9514(14)60268-3. No abstract available.
PubMed 11552877
Wessels M, Lucas C, Eriks I, de Groot S. Body weight-supported gait training for restoration of walking in people with an incomplete spinal cord injury: a systematic review. J Rehabil Med. 2010 Jun;42(6):513-9. doi: 10.2340/16501977-0525.
PubMed 20549154
Dobkin B, Barbeau H, Deforge D, Ditunno J, Elashoff R, Apple D, Basso M, Behrman A, Harkema S, Saulino M, Scott M; Spinal Cord Injury Locomotor Trial Group. The evolution of walking-related outcomes over the first 12 weeks of rehabilitation for incomplete traumatic spinal cord injury: the multicenter randomized Spinal Cord Injury Locomotor Trial. Neurorehabil Neural Repair. 2007 Jan-Feb;21(1):25-35. doi: 10.1177/1545968306295556.
PubMed 17172551
Franceschini M, Carda S, Agosti M, Antenucci R, Malgrati D, Cisari C; Gruppo Italiano Studio Allevio Carico Ictus. Walking after stroke: what does treadmill training with body weight support add to overground gait training in patients early after stroke?: a single-blind, randomized, controlled trial. Stroke. 2009 Sep;40(9):3079-85. doi: 10.1161/STROKEAHA.109.555540. Epub 2009 Jun 25.
PubMed 19556526
Hoyer E, Jahnsen R, Stanghelle JK, Strand LI. Body weight supported treadmill training versus traditional training in patients dependent on walking assistance after stroke: a randomized controlled trial. Disabil Rehabil. 2012;34(3):210-9. doi: 10.3109/09638288.2011.593681.
PubMed 21954995
Ada L, Dean CM, Hall JM, Bampton J, Crompton S. A treadmill and overground walking program improves walking in persons residing in the community after stroke: a placebo-controlled, randomized trial. Arch Phys Med Rehabil. 2003 Oct;84(10):1486-91. doi: 10.1016/s0003-9993(03)00349-6.
PubMed 14586916
Kosak MC, Reding MJ. Comparison of partial body weight-supported treadmill gait training versus aggressive bracing assisted walking post stroke. Neurorehabil Neural Repair. 2000;14(1):13-9. doi: 10.1177/154596830001400102.
PubMed 11228945
Visintin M, Barbeau H, Korner-Bitensky N, Mayo NE. A new approach to retrain gait in stroke patients through body weight support and treadmill stimulation. Stroke. 1998 Jun;29(6):1122-8. doi: 10.1161/01.str.29.6.1122.
PubMed 9626282
Teixeira da Cunha Filho I, Lim PA, Qureshy H, Henson H, Monga T, Protas EJ. A comparison of regular rehabilitation and regular rehabilitation with supported treadmill ambulation training for acute stroke patients. J Rehabil Res Dev. 2001 Mar-Apr;38(2):245-55.
PubMed 11392657
Werner C, Von Frankenberg S, Treig T, Konrad M, Hesse S. Treadmill training with partial body weight support and an electromechanical gait trainer for restoration of gait in subacute stroke patients: a randomized crossover study. Stroke. 2002 Dec;33(12):2895-901. doi: 10.1161/01.str.0000035734.61539.f6.
PubMed 12468788

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Usability of a New Overground Body Weight Support Rehabilitation Robot LEAP: A Monocentric Consideration-of-concept Trial
ClinicalTrials.gov ID: NCT03458169
Acronym / sponsor ID: LEAP / CliniqueRR-05
Conditions: Spinal Cord Injuries, Cerebral Palsy, Parkinson Disease, Multiple Sclerosis, Stroke, People With Impaired Lower Extremity Function
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Clinique Romande de ReadaptationResearch network
Study start: 1 Jan 2018 (actual)
Primary completion: 30 Apr 2018 (actual)
Study completion: 30 Apr 2018 (actual)
First posted: 8 Mar 2018 (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.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LEAP usability	Experimental	Device: Therapist LEAP session feedback, Device: Participant LEAP session feedback, Device: LEAP risk control validation* Therapist LEAP session feedback * Participant LEAP session feedback * LEAP risk control validation

Who may qualify

Ages: 5 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

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
Therapist LEAP session feedbackA standard therapy session is being performed with a participant with the LEAP body-weight support robot. Subsequently, the therapist is answering a questionnaire to assess the clinical applicability of the robot. An observer will assess with a questionnaire whether use errors occurred during the session.	Device	LEAP usability
Participant LEAP session feedbackA standard therapy session is being performed with a participant inside the LEAP body-weight support robot. Subsequently, the participant is answering a questionnaire to assess the comfort of the robot.	Device	LEAP usability
LEAP risk control validationThe therapist rates the risk control measurements of the LEAP robot with a questionnaire, during a session with a member of the investigational team.	Device	LEAP usability

Primary outcome

Usability of the robot - Fixation
Time frame: 2 minutes
From the user/therapist the information on the usability of the robot (CRF I) is being assessed. This questionnaire is only filled once by each user/therapist. Feedback on patient/subject fixation (Ordinal scale from 1:useful to 5:not useful)
Usability of the robot - Applicability
Time frame: 2 minutes
From the user/therapist the information on the usability of the robot (CRF I) is being assessed. This questionnaire is only filled once by each user/therapist. Feedback on clinical applicability (Ordinal scale from 1:useful to 5:not useful)
Usability of the robot - Robot support
Time frame: 2 minutes
From the user/therapist the information on the usability of the robot (CRF I) is being assessed. This questionnaire is only filled once by each user/therapist. Feedback on robot support (Ordinal scale from 1:useful to 5:not useful)
Usability of the robot - User interface
Time frame: 2 minutes
From the user/therapist the information on the usability of the robot (CRF I) is being assessed. This questionnaire is only filled once by each user/therapist. Feedback on user interface (Graphical user interface) (Ordinal scale from 1:useful to 5:not useful)
Usability of the robot - Interaction
Time frame: 2 minutes
From the user/therapist the information on the usability of the robot (CRF I) is being assessed. This questionnaire is only filled once by each user/therapist. Feedback on the LEAP interaction (Ordinal scale from 1:useful to 5:not useful)
Risk control validation - Observer
Time frame: 1 hour
From an independent observer (investigator, or a member of the development team) the occurrence of use errors is recorded (CRF III): Each primary operating function of the robot is rated (Ordinal scale from 0 to 1 for 'use error occurred' or 'no use error' This questionnaire has only to be filled out once for each user/therapist.
Risk control validation - User
Time frame: 1 hour
The risk control measures are validated by the user/therapist (CRF IV): The different risk controls are rated (Ordinal scale from 0 to 1 for 'Acceptable' or 'Not acceptable') This questionnaire has only to be filled out once by each user/therapist.
Participant feeling of safety/comfort - Fixation
Time frame: 1 minute
From the participant information on the comfort/safety is being assessed (CRF II): Feedback on the fixation of the patient (Open-ended question)
Participant feeling of safety/comfort - Robot training
Time frame: 1 minute
From the participant information on the comfort/safety is being assessed (CRF II): Feedback on the robot training (Ordinal scale from 0 to 5)
Participant feeling of safety/comfort - Robot support
Time frame: 1 minute
From the participant information on the comfort/safety is being assessed (CRF II): Feedback on the robot support (Ordinal scale from 0 to 5)

21 secondary outcomes

Robot Measurement - Patient position
Time frame: 1 hour
Robot Measurement - Walking speed
Time frame: 1 hour
Robot Measurement - Occurred errors
Time frame: 1 hour
Robot Measurement - Support forces
Time frame: 1 hour
Robot Measurement - Fall detection
Time frame: 1 hour
Robot Measurement - Walked distance
Time frame: 1 hour
EMG system
Time frame: 1 hour
Patient characteristics - Testing date
Time frame: 1 minutes
Patient characteristics - Identification number
Time frame: 1 minutes
Patient characteristics - Body height
Time frame: 1 minutes
Patient characteristics - Body weight
Time frame: 1 minutes
Patient characteristics - Waist size
Time frame: 1 minutes
Patient characteristics - Tight circumference
Time frame: 1 minutes
Patient characteristics - Chest size
Time frame: 1 minutes
Patient characteristics - Age
Time frame: 1 minutes
Patient characteristics - Stationary or ambulant
Time frame: 1 minutes
Patient characteristics - Dominant side
Time frame: 1 minutes
Patient characteristics - Walking aid
Time frame: 1 minutes
Patient characteristics - Six minute walking test
Time frame: 1 minutes
Patient characteristics - BAECKE score
Time frame: 1 minutes
Patient characteristics - Fugl-Meyer score
Time frame: 1 minutes

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 30 Jan 2019.
Background: PubMed 21586596Freund P, Weiskopf N, Ward NS, Hutton C, Gall A, Ciccarelli O, Craggs M, Friston K, Thompson AJ. Disability, atrophy and cortical reorganization following spinal cord injury. Brain. 2011 Jun;134(Pt 6):1610-22. doi: 10.1093/brain/awr093. Epub 2011 May 17.
Background: PubMed 10896007Kennedy P, Rogers BA. Anxiety and depression after spinal cord injury: a longitudinal analysis. Arch Phys Med Rehabil. 2000 Jul;81(7):932-7. doi: 10.1053/apmr.2000.5580.
Background: PubMed 10917267Fehr L, Langbein WE, Skaar SB. Adequacy of power wheelchair control interfaces for persons with severe disabilities: a clinical survey. J Rehabil Res Dev. 2000 May-Jun;37(3):353-60.
Background: PubMed 15520982Hunt PC, Boninger ML, Cooper RA, Zafonte RD, Fitzgerald SG, Schmeler MR. Demographic and socioeconomic factors associated with disparity in wheelchair customizability among people with traumatic spinal cord injury. Arch Phys Med Rehabil. 2004 Nov;85(11):1859-64. doi: 10.1016/j.apmr.2004.07.347.
Background: PubMed 25311847Meyns P, Van de Crommert HW, Rijken H, van Kuppevelt DH, Duysens J. Locomotor training with body weight support in SCI: EMG improvement is more optimally expressed at a low testing speed. Spinal Cord. 2014 Dec;52(12):887-93. doi: 10.1038/sc.2014.172. Epub 2014 Oct 14.
Background: PubMed 11552877Crompton S, Khemlani M, Batty J, Ada L, Dean C, Katrak P. Practical issues in retraining walking in severely disabled patients using treadmill and harness support systems. Aust J Physiother. 2001;47(3):211-3. doi: 10.1016/s0004-9514(14)60268-3. No abstract available.
Background: PubMed 20549154Wessels M, Lucas C, Eriks I, de Groot S. Body weight-supported gait training for restoration of walking in people with an incomplete spinal cord injury: a systematic review. J Rehabil Med. 2010 Jun;42(6):513-9. doi: 10.2340/16501977-0525.
Background: PubMed 17172551Dobkin B, Barbeau H, Deforge D, Ditunno J, Elashoff R, Apple D, Basso M, Behrman A, Harkema S, Saulino M, Scott M; Spinal Cord Injury Locomotor Trial Group. The evolution of walking-related outcomes over the first 12 weeks of rehabilitation for incomplete traumatic spinal cord injury: the multicenter randomized Spinal Cord Injury Locomotor Trial. Neurorehabil Neural Repair. 2007 Jan-Feb;21(1):25-35. doi: 10.1177/1545968306295556.
Background: PubMed 19556526Franceschini M, Carda S, Agosti M, Antenucci R, Malgrati D, Cisari C; Gruppo Italiano Studio Allevio Carico Ictus. Walking after stroke: what does treadmill training with body weight support add to overground gait training in patients early after stroke?: a single-blind, randomized, controlled trial. Stroke. 2009 Sep;40(9):3079-85. doi: 10.1161/STROKEAHA.109.555540. Epub 2009 Jun 25.
Background: PubMed 21954995Hoyer E, Jahnsen R, Stanghelle JK, Strand LI. Body weight supported treadmill training versus traditional training in patients dependent on walking assistance after stroke: a randomized controlled trial. Disabil Rehabil. 2012;34(3):210-9. doi: 10.3109/09638288.2011.593681.
Background: PubMed 14586916Ada L, Dean CM, Hall JM, Bampton J, Crompton S. A treadmill and overground walking program improves walking in persons residing in the community after stroke: a placebo-controlled, randomized trial. Arch Phys Med Rehabil. 2003 Oct;84(10):1486-91. doi: 10.1016/s0003-9993(03)00349-6.
Background: PubMed 11228945Kosak MC, Reding MJ. Comparison of partial body weight-supported treadmill gait training versus aggressive bracing assisted walking post stroke. Neurorehabil Neural Repair. 2000;14(1):13-9. doi: 10.1177/154596830001400102.
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.

Urs Keller, PhD principal investigator

Ecole Polytechnique Fédérale de Lausanne

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 30 Jan 2019. 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 robot - Fixation (time frame: 2 minutes). The study lists 10 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 NCT03458169, which also lists 40 linked publications.

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 30 Jan 2019.