NCT05423626

Innovative Technologies in Restoring Gait and Balance Funtions in Ischemic Stroke Patients at the Inpatient Stage

Status unknown NA Last updated 21 June 2022

What this trial tests

NA trial testing technologies of robotic mechanotherapy with FES in Ischemic Stroke, Acute in 120 participants. Status unknown.

Timeline

18 March 2022

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	120
Start date	18 March 2022
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across Russia

Drugs / interventions tested

• technologies of robotic mechanotherapy with FES
• biofeedback virtual reality technologies

Conditions studied

• Ischemic Stroke, Acute — all drugs for Ischemic Stroke, Acute →

Sponsor

Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine

Who can join

Adults 19 to 75, any sex, with Ischemic Stroke, Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The scientific hypothesis was based on data on the effectiveness of the usage of robotic mechanotherapy and virtual reality technologies. Purpose of the study is the development and scientific substantiation of the effectiveness and safety of rehabilitation programs using the technology of robotic mechanotherapy (exoskeleton) with functional electrical stimulation (FES) and virtual reality (VR) technology with biofeedback (BFB) in restoring walking and balance disorders at the stationary stage of medical rehabilitation in patients in acute and early recovery periods of ischemic stroke. The duration of the study is 2 years. The study is planned to include 120 patients. Anamnesis collection, physical and neurological examination will be carried out for all patients upon admission. Diagnostic transcranial magnetic stimulation, electroencephalography and stabilometry will also be performed upon admission and discharge. Adverse events will be assessed. On the last day of the study, the dynamics of the volume and strength of movements, functional independence and spasticity will be assessed according to the scales (MRC, NIHSS, mAS, mRS, Rivermead, Hauser walking index, Tinetti scale, SHRM, ICF, Tampa scale, EQ-5D-5L), as well as the assessment of mental and cognitive status according to HADs and MoCA. Patients will be randomly divided into 4 groups: 3 main and 1 control. All patients will undergo a basic rehabilitation course. In the first group (exoskeleton with FES): 10 procedures, 5 times a week, the duration of the course of medical rehabilitation is 12-14 days. The total duration of one procedure is 1 hour. In the second group (VR technologies with BFB): 10 procedures, 5 times a week, the duration of the course of medical rehabilitation is 12-14 days. The total duration of one procedure is 30 minutes. In the third group (Complex application of robotic mechanotherapy technologies with FES and VR with biofeedback): 10 procedures, 5 times a week, the duration of the course of medical rehabilitation is 12-14 days. The total duration of training with VR is 30 minutes, then no earlier than 2 hours later, training on an exoskeleton, lasting no more than 1 hour. Patients in the control group will receive comprehensive rehabilitation procedures as prescribed, during the course of treatment accepted in a medical institution.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.