Robotic-assisted walking therapy for people in the subacute phase of stroke
The Effectiveness of Subacute Stroke Patients Receiving Robotic Assisted Gait Training
This trial will test whether adding robotic-assisted gait training to regular physical therapy helps people 1 to 3 months after a stroke improve their walking and daily function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 45 Years to 70 Years |
| Sex | All |
| Sponsor | Changhua Christian Hospital Academic / other |
| Locations | 1 site (Changhua, Taiwan) |
| Trial ID | NCT07040215 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial enrolling 20 subacute stroke patients who will be assigned to either robotic-assisted gait training plus traditional physiotherapy or to traditional physiotherapy alone. The robotic intervention uses a Freewalk lower-limb device to provide high-intensity, repetitive gait practice in addition to routine rehabilitation. Gait performance and functional measures will be collected during the rehabilitation period to compare the two groups. The study is single-center and aims to inform more personalized post-stroke rehabilitation approaches.
Who should consider this trial
Good fit: Ideal candidates are people 1 to 3 months after ischemic or hemorrhagic stroke who have moderate-to-good standing balance, can follow instructions cognitively, weigh 90 kg or less, and can attend in-person rehabilitation sessions.
Not a fit: Patients with severe cardiovascular or cardiopulmonary disease, very high spasticity or joint contractures, other neurological disorders, major cognitive impairment, or who exceed the device weight limit are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the combined approach could speed recovery of walking ability and improve daily functional mobility for subacute stroke patients.
How similar studies have performed: Previous randomized trials and meta-analyses have shown that robotic-assisted gait training can improve walking speed and functional outcomes for some subacute stroke patients, although results have varied by patient subgroup and device.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with stroke (ischemic or hemorrhagic) confirmed by medical imaging. * Subacute phase of stroke (onset within 1 to 3 months). * Moderate to good standing balance ability. * Sufficient cognitive ability to understand the study and follow instructions. * Able to participate in rehabilitation training during the study period. Exclusion Criteria: * Body weight over 90 kg. * Presence of other neurological disorders. * Severe cardiovascular disease or other health conditions affecting mobility. * Significant lower limb pain, joint contracture, or spasticity (Modified Ashworth Scale score \> 3) that impairs walking. * Diagnosed with cardiopulmonary disease that contraindicates exercise training. * Cognitive impairment that prevents understanding of training instructions or completion of questionnaires. * Inability to complete the rehabilitation training protocol.
Where this trial is running
Changhua, Taiwan
- Changhua Christian Hospital — Changhua, Taiwan, Taiwan (Recruiting)
Study contacts
- Principal investigator: Su-Fen Liao — Changhua Christian Hospital
- Study coordinator: Office of Human Subject Protection Changhua Christian Hospital
- Email: d9010@cch.org.tw
- Phone: 886-4-7238595
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.