Is preparatory training with intensive visual stimulation feasible in stroke patients to reduce body weight support over four weeks during robot-assisted gait training?
Summary description of the study
After signing the written information and consent form, the inclusion criteria will be checked, supported by a recognition test for cognitive impairment (MoCA test). Then, if the person meets the criteria, the participant will be randomly assigned to one of the groups: preparatory exercises with or without intensive visual stimulation. The first Lokomat training serves to set up the device. In the second training session on the Lokomat, the extent of the required body weight support and guidance force will be determined. No further examinations will be conducted during the six additional training sessions at the Valens rehabilitation center. In each Lokomat training, the protocol of preparatory exercises with or without intensive visual stimulation will be carried out, depending on the group. In the last training session on the Lokomat, the initial measurements (body weight support and guidance force during Lokomat training) will be repeated. Around the last training session, a personal 30-60 minute interview will also be conducted with some participants to gather opinions and experiences regarding the preparatory training to assess feasibility.
(BASEC)
Intervention under investigation
The IVS4 is a device for intensive visual stimulation, based on the combination of three therapy forms: motor imagery (MI), mirror therapy (MT), and action observation (AO) (Dessintey, 2025), designed for the lower extremities. The goal is to promote relearning and to regain leg function, relying on the brain's neuroplasticity. In this study, individuals assigned to the intervention group will perform a series of preparatory exercises with the IVS4 under the supervision of physiotherapists before training with the Lokomat. The Lokomat training takes place three times a week and lasts about 45 minutes per training session for each participant. Overall, the training lasts approximately 60 minutes, all of which are supervised.
(BASEC)
Disease under investigation
A subacute stroke (<6 months ago) affecting the legs, impairing walking ability
(BASEC)
We are asking adult individuals (18 years or older) with an acute stroke (<6 months old) who cannot walk independently to participate in the study. Participants must be able to understand German and communicate verbally and must undergo at least 4 weeks of rehabilitation at the Valens rehabilitation center. (BASEC)
Exclusion criteria
Participation is not possible if significant illnesses and health problems or severe cognitive impairments are present. Additionally, it will be checked whether Lokomat training is feasible, requiring a weight of <135 kg and that the thighs fit into the device (thighs >47 cm or <35 cm). (BASEC)
Trial sites
Other
(BASEC)
Valens
(BASEC)
Sponsor
Dr Roman Gonzenbach
(BASEC)
Contact
Contact Person Switzerland
Jens Bansi
058 511 1302
jens.bansi@clutterkliniken-valens.chKliniken Valens
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethikkommission Ostschweiz EKOS
(BASEC)
Date of authorisation
03.04.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Is Preparatory Exercising with Intensive Visual Stimulation feasible in subacute Stroke to reduce Body Weight Support over four weeks robotic assisted gait training? (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available