None listed
Conditions
Brief summary
This study focuses on the recovery of mobility issues in post-stroke patients, specifically in postural control and gait, areas affected in 70-80% of survivors. Hemiparesis is the primary cause of disability, affecting up to 80% of patients with persistent gait problems even after rehabilitation. Among the available therapeutic tools, technological feedback devices have shown promise, particularly haptic feedback, which provides optimal sensory information and facilitates sensorimotor integration and motor learning. This study aims to evaluate the effectiveness of haptic feedback on the gait and postural control of post-stroke patients for future clinical implementation. Thus, the main hypothesis of this study is that an early physiotherapeutic intervention with haptic feedback will promote better recovery of trunk control and/or gait in post-stroke patients.
Interventions
The physiotherapy intervention will be conducted using a haptic feedback device (ReMoD V5.0). This device, configured as a vest with electrostimulation and an inclinometer, provides stimuli when the trunk tilts beyond the set degrees, promoting appropriate proprioceptive feedback.
The intervention will include passive and active mobility exercises, postural and motor control, gait recovery, balance, transfers, and lower limb strength, with a task-based approach to facilitate optimal motor patte
The physiotherapy intervention will be conducted using a haptic feedback device (ReMoD V5.0). This device, configured as a vest with electrostimulation and an inclinometer, provides stimuli when the trunk tilts beyond the set degrees, promoting appropriate proprioceptive feedback. The intervention will include passive and active mobility exercises, postural and motor control, gait recovery, balance, transfers, and lower limb strength, with a task-based approach to facilitate optimal motor pattern acquisition. Examples of key exercises included in the intervention are: reach exercises for weight transfer, squats and strength training with elastic bands, balance circuits, dual-task and motor coordination exercises, and a specific focus on walking (progressively reducing assistance to the correction of compensations, development in different grounds and specific circuits for the improvement of spatiotemporal aspects that need to be worked on). All sessions will be conducted and supervised by a physiotherapist. The experimental group will use the activated device during treatment sessions in a hospital enviroment. The intervention will consist of six one-hour sessions over 15 days (with 2 days between each session). Additionally, the experimental group will use the device autonomously for 3 hours daily on all 15 days of the study period. The unsupervised use of the vest will be intended for the basic activities of daily living without any additional instruction to follow any home exercise protocol. Adherence to the treatment will be monitored through the completion of session attendance checklists and continuous telematic follow-up with the families and patients during the intervention weeks.
Sponsors
Departamento de Fisioterapia, University of Seville
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with a first stoke episode. Patients without contraindications of early mobilitation. Patients who have signed the informed consent, show voluntariness to participate and can complete the scales and the protocol. Minimum score of 1 point in Functional Ambulation Category (FAC) or minimum score of 20 points in Postural Assesment Scale for Stroke (PASS).
Exclusion criteria
Intravenous thrombosis or arterial thrombectomy before admission. Dementia or significant cognitive impairment. Presence of diseases such as severe cardiovascular disease, arrhythmias or other heart disorders, cancer, epilepsy or infections with risk of septicemia. Presence of another neurological or musculoskeletal disease (Parkinson's disease, peripheral neuropathy...) or any condition other than the one under study that may influence the development of the patients' gait and balance. Skin and dermatological alterations. Pregnancy or possibility of pregnancy. Pacemaker or other metallic implant.
Outcome results
None listed