Biofeedback training for improving walking after stroke
Blind Randomized Controlled Study of Biofeedback Training Based on Target Biomechanical Gait Parameters at Patients in the Early Recovery Period of Stroke Whith Hemiparesis
This study is testing whether biofeedback training can help people who have had a stroke improve their walking by giving them real-time feedback on their movement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health Academic / other |
| Locations | 1 site (Moscow) |
| Trial ID | NCT06299943 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of biofeedback gait training based on specific biomechanical parameters in patients recovering from ischemic stroke. Participants will undergo 8-11 sessions of training, where their gait will be monitored and adjusted using real-time feedback on various biomechanical metrics. The study aims to compare the changes in these parameters before and after training, as well as against healthy adults, to assess the impact of this targeted approach on walking function. The trial is single-blinded and controlled to ensure reliable results.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals under 75 years old who have experienced an ischemic stroke and can walk independently for at least 5 minutes.
Not a fit: Patients with worsening neurological deficits or those experiencing orthostatic hypotension during training may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance rehabilitation outcomes for stroke patients by improving their walking ability.
How similar studies have performed: Previous studies have shown promise in using biofeedback for gait training, but this specific approach focusing on biomechanical parameters is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age - \< 75 years; * type of stroke - ischemic; * structure of the lesion - cerebral hemisphere; * disease type - primary; * functional ability to walk for at least 5 minutes without using external means of support; * absence of reduced higher mental functions, * sensorimotor aphasia, * muscle tone in the limbs above 2 points according to Ashworth (Modified Ashworth Scale); * no history of orthopedic and neurological pathology; absence of pronounced pain syndrome Exclusion Criteria: * Signs of orthostatic hypotension during training, * patient desire to withdraw from the study, * neurological deficit worsening.
Where this trial is running
Moscow
- FCCerebroPathStroke — Moscow, Russian Federation (Recruiting)
Study contacts
- Study coordinator: Dmitry V Skvortsov, PhD
- Email: skvortsov.biom@gmail.com
- Phone: +79166925419
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.