Robot-assisted gait therapy for stroke recovery
Robot-Assisted Gait Therapy in the Subacute Phase of First Ischemic Stroke
This study is testing if using a robot to help people walk after their first stroke can improve their walking ability better than just regular rehab alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Ostrava Academic / other |
| Locations | 1 site (Ostrava, Moravian-Silesian Region) |
| Trial ID | NCT04910217 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of robot-assisted gait training (RAGT) using the Lokomat exoskeleton device in patients recovering from their first ischemic stroke. Participants will be randomly assigned to receive either RAGT combined with conventional rehabilitation or conventional rehabilitation alone. The study aims to assess improvements in gait function over a period of six months, with various outcome measures including the Functional Ambulation Category and walking tests. The trial is designed to provide blinded assessments of the primary outcomes to ensure objectivity.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years who have experienced their first ischemic stroke within the last six weeks and have specific mobility limitations.
Not a fit: Patients with a history of stroke or severe comorbidities that affect rehabilitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance gait recovery in stroke patients, leading to improved mobility and quality of life.
How similar studies have performed: Previous studies have shown promising results with robotic rehabilitation approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * signed informed consent by the participant or legal representative * interval between stroke and first rehabilitation session \< 6 weeks (study target within 2 weeks) * age \> 18 years * early modified Rankin scale (mRS) 2 to 4 (pre-stroke mRS 0 to 1) * early FAC of 0 to 3 (pre-stroke FAC of 5) * standing ability with support up to 3 minutes and vertical tolerance \> 15 minutes Exclusion Criteria: * inability or refusal to sign an informed consent * history of stroke or another brain disease (tumour, multiple sclerosis, brain or spinal cord injury) * severe internal, oncological, or surgical comorbidity preventing long-term re-habilitation or causing chronic or progressive gait disorder * limited collaboration of any reason, moderate or severe dementia assessed by using the Montreal Cognitive Assessment (MoCA) scale * impaired skin integrity in the lower torso and limbs preventing the use of Lokomat device * limitations given by the Lokomat exoskeleton device (weight \> 135 kg, thigh-length 23-35 cm, shank length 35-47cm) * limitations given by the leg/lower body exerciser (weight \> 180 kg, height \< 120 cm or \> 200 cm, (sub)acute lower limb fractures, deep vein thrombosis, skin disintegration) * any contraindication to perform brain MRI
Where this trial is running
Ostrava, Moravian-Silesian Region
- University Hospital Ostrava — Ostrava, Moravian-Silesian Region, Czechia (Recruiting)
Study contacts
- Principal investigator: Ondřej Volný, MD,PhD,FESO — University Hospital Ostrava
- Study coordinator: Jiří Hynčica
- Email: jiri.hyncica@fno.cz
- Phone: 0042059737
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.