Informations générales
  • Catégorie de maladie Autre (BASEC)
  • État du recrutement recrutement pas encore commencé (BASEC/ICTRP)
  • Lieu de l’étude
    Autre
    (BASEC)
  • Responsable de l'étude Jens Bansi jens.bansi@kliniken-valens.ch (BASEC)
  • Source(s) de données BASEC: Importé de 03.04.2025 ICTRP: N/A
  • Date de mise à jour 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?

  • Catégorie de maladie Autre (BASEC)
  • État du recrutement recrutement pas encore commencé (BASEC/ICTRP)
  • Lieu de l’étude
    Autre
    (BASEC)
  • Responsable de l'étude Jens Bansi jens.bansi@kliniken-valens.ch (BASEC)
  • Source(s) de données BASEC: Importé de 03.04.2025 ICTRP: N/A
  • Date de mise à jour 03.04.2025 11:20

Résumé de l'étude

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 étudiée

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)

Maladie en cours d'investigation

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

(BASEC)

Critères de participation
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)

Critères d'exclusion
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)

Lieu de l’étude

Autre

(BASEC)

Valens

(BASEC)

non disponible

Sponsor

Dr Roman Gonzenbach

(BASEC)

Contact pour plus d'informations sur l'étude

Personne de contact en Suisse

Jens Bansi

058 511 1302

jens.bansi@kliniken-valens.ch

Kliniken Valens

(BASEC)

Informations scientifiques

non disponible

Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)

Ethikkommission Ostschweiz EKOS

(BASEC)

Date d'approbation du comité d'éthique

03.04.2025

(BASEC)


Identifiant de l'essai ICTRP
non disponible

Titre officiel (approuvé par le comité d'éthique)
Is Preparatory Exercising with Intensive Visual Stimulation feasible in subacute Stroke to reduce Body Weight Support over four weeks robotic assisted gait training? (BASEC)

Titre académique
non disponible

Titre public
non disponible

Maladie en cours d'investigation
non disponible

Intervention étudiée
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Type d'essai
non disponible

Plan de l'étude
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Critères d'inclusion/exclusion
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non disponible

Critères d'évaluation principaux et secondaires
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non disponible

Date d'enregistrement
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Inclusion du premier participant
non disponible

Sponsors secondaires
non disponible

Contacts supplémentaires
non disponible

ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai

Résumé des résultats

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Lien vers les résultats dans le registre primaire

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