StimuLOOP.S - Sensomotor Precision Neuro-Rehabilitation through Personalized Stimulation Loops after Stroke

Descrizione riassuntiva dello studio

The aim of the study is to improve the recovery of walking function in patients after a stroke. Specifically, we want to find out whether we - with rehabilitation training tailored to their individual needs - and through consolidation of what has been learned during sleep the quality of walking and mobility after their stroke can be learned quickly and sustainably. We hope to use this information to enable better rehabilitation outcomes for stroke patients in the future. A stroke often leads to limitations in walking. Rehabilitation is an important means to improve or even regain walking quality after a stroke. However, results can vary significantly from patient to patient. To ensure optimal rehabilitation for all, we want to investigate the success of personalized rehabilitation in conjunction with the consolidation of learning during sleep in this study. To address this question, we have developed a study in which you will be randomly assigned to one of two groups. Depending on which of the two groups you are placed in, you will receive a different rehabilitation training.  Group 1: Personalized rehabilitation without intervention for consolidation of learning during sleep.  Group 2: Personalized rehabilitation with intervention for consolidation of learning during sleep. A total of 40 people will participate in the study. The conduct of the study follows the prescribed laws in Switzerland. Furthermore, we adhere to all internationally recognized guidelines. The responsible cantonal ethics committee has reviewed and approved the study.

(BASEC)

Intervento studiato

All examinations for the mentioned study will be conducted at the Cereneo Rehabilitation Clinic. They will be carried out within the clinical routine. This will not incur any additional costs for you.

First, the walking pattern of the study participants will be comprehensively analyzed. Various standardized walking tests (e.g., walking on a treadmill) will be conducted. Additionally, walking will be recorded for three days using sensors on the lower back, wrist, and ankle joints.

If there is a suspicion that the study participant suffers from breathing difficulties (so-called “apnea”) during sleep, we will also measure breathing, pulse, and oxygen saturation during sleep at a individually agreed measurement at home (a so-called “polysomnography”).

Participants will then have one to three nights of acclimatization to sleep with a portable EEG (“sleep device”). One of these nights will be with a high-resolution EEG. In both cases, sounds will be played at precisely defined times through integrated headphones at a volume that is low enough not to disturb natural sleep.

After we have comprehensively analyzed the walking and sleep patterns, participants will receive a training program specifically tailored to their needs. This lasts for 15 days, from Monday to Friday, over three weeks. The training will be supported by background noise. During the night, what has been learned should be consolidated. For this purpose, participants will sleep with the small sleep device from the preparation phase. Throughout the entire training period, participants will also be asked to wear a wrist sensor that records their physical activity, similar to a pedometer. Additionally, their current well-being will be assessed every evening before bedtime and every morning after waking up using a short questionnaire.

Immediately after the 15-day training, we will analyze the walking and sleep of the participants again in depth (using further walking tests, wearing sensors, and a second night with high-resolution EEG). The walking analysis will then be repeated one month later. These analyses serve to assess the success of the training.

(BASEC)

Malattie studiate

Stroke with walking impairment

(BASEC)

Sponsor

Prof. Dr. med. Andreas Luft, Universität Zürich und Universitätsspital Zürich

(BASEC)

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

Commissione d'etica svizzera nord-ovest/centrale EKNZ

(BASEC)

Data di approvazione del comitato etico

16.11.2022

(BASEC)

Risultati dello studio