Informazioni generali
  • Categoria della malattia Altro (BASEC)
  • Stato di reclutamento reclutamento non ancora iniziato (BASEC/ICTRP)
  • Luogo dello studio
    Altro
    (BASEC)
  • Responsabile dello studio Jens Bansi jens.bansi@kliniken-valens.ch (BASEC)
  • Fonte dati BASEC: Importato da 03.04.2025 ICTRP: N/A
  • Ultimo aggiornamento 03.04.2025 11:20
HumRes66634 | SNCTP000006350 | BASEC2025-00446

Is preparatory training with intensive visual stimulation feasible in stroke patients to reduce body weight support over four weeks during robot-assisted gait training?

  • Categoria della malattia Altro (BASEC)
  • Stato di reclutamento reclutamento non ancora iniziato (BASEC/ICTRP)
  • Luogo dello studio
    Altro
    (BASEC)
  • Responsabile dello studio Jens Bansi jens.bansi@kliniken-valens.ch (BASEC)
  • Fonte dati BASEC: Importato da 03.04.2025 ICTRP: N/A
  • Ultimo aggiornamento 03.04.2025 11:20

Descrizione riassuntiva dello studio

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)

Intervento studiato

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)

Malattie studiate

A subacute stroke (<6 months ago) affecting the legs, impairing walking ability

(BASEC)

Criteri di partecipazione
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)

Criteri di esclusione
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)

Luogo dello studio

Altro

(BASEC)

Valens

(BASEC)

non disponibile

Sponsor

Dr Roman Gonzenbach

(BASEC)

Contatto per ulteriori informazioni sullo studio

Persona di contatto in Svizzera

Jens Bansi

058 511 1302

jens.bansi@kliniken-valens.ch

Kliniken Valens

(BASEC)

Informazioni scientifiche

non disponibile

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Ethikkommission Ostschweiz EKOS

(BASEC)

Data di approvazione del comitato etico

03.04.2025

(BASEC)


ID di studio ICTRP
non disponibile

Titolo ufficiale (approvato dal comitato etico)
Is Preparatory Exercising with Intensive Visual Stimulation feasible in subacute Stroke to reduce Body Weight Support over four weeks robotic assisted gait training? (BASEC)

Titolo accademico
non disponibile

Titolo pubblico
non disponibile

Malattie studiate
non disponibile

Intervento studiato
non disponibile

Tipo di studio
non disponibile

Disegno dello studio
non disponibile

Criteri di inclusione/esclusione
non disponibile

non disponibile

Endpoint primari e secondari
non disponibile

non disponibile

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
non disponibile

ID secondari
non disponibile

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
non disponibile

Risultati dello studio

Riepilogo dei risultati

non disponibile

Link ai risultati nel registro primario

non disponibile