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The goal of this randomized, single-blind clinical trial is to learn whether a 4-week Lokomat-based gait training program with plantar pressure feedback can improve gait symmetry and balance in adult patients with chronic hemiplegic stroke. The main questions it aims to answer are:
Does Lokomat training with plantar pressure feedback improve spatiotemporal gait symmetry, as measured with the GAITRite system, more than Lokomat training without plantar pressure feedback? Does this intervention lead to greater improvements in balance and walking speed, assessed by the Berg Balance Scale (BBS) and the 10-Meter Walk Test (10MWT), compared with conventional Lokomat training? Researchers will compare a group receiving Lokomat training with both real-time feedback and additional summary plantar pressure feedback to a group receiving Lokomat training with real-time feedback only, to see if adding plantar pressure feedback results in superior gains in gait symmetry, balance, and walking ability.
Participants will be adult inpatients with chronic hemiplegic stroke. They will be randomly assigned to one of the two training groups and will receive Lokomat-based gait training three times per week for 30 minutes per session over four weeks. Before and after the intervention period, participants will undergo gait analysis using the GAITRite walkway and clinical assessments including the BBS and 10MWT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lokomat with plantar pressure summary feedback | Experimental | Participants receive 30 minute Lokomat(robot-assisted gait training) with real-time feedback plus additional plantar pressure summary feedback. Training is provided 3 times per week for 4 weeks. Balance and gait symmetry are assessed before and after the intervention |
|
| Real-time feedback(biofeedback program) | Active Comparator | Participants receive 30 minute Lokomat(robot-assisted gait training) training with real-time feedback only. Training is provided 3 times per week for 4 weeks. Balance and gait symmetry are assessed before and after the intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lokomat robot assisted gait training | Device | Lokomat robot assisted gait training for 30 minutes per session, 3 times per week, for 4 weeks. Real-time(biofeedback graph) visual and auditory feedback provided by the Lokomat system is used during gait training in both groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gait symmetry(GaitRite) | Change from baseline to 4 weeks after randomization(end of intervention) | |
| Change in gait symmetry(10-meter walk test) | Change from baseline to 4 weeks after randomization(end of intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in balance performance(Berg Balance Test) | Change from baseline to 4 weeks after randomization(end of intervention) | |
| Change in balance performance(Timed Up and Go test) | Change from baseline to 4 weeks after randomization(end of intervention) |
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Inclusion Criteria:
Exclusion Criteria:
Vulnerable Populations:
This study includes only adult participants and does not enroll legally vulnerable populations such as minors or pregnant women. For inpatients, potential reduction in voluntariness due to relationships with treating clinicians is minimized by obtaining consent from a non-treating researcher, allowing sufficient time for decision-making, permitting withdrawal at any time without penalty, and allowing a caregiver to be present during the consent process if desired.
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| Name | Affiliation | Role |
|---|---|---|
| seongwon Lee, PhD, PT | Sahmyook University, Department of Physical Therapy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duksoo Medical Foundation Seoul Brain Hospital | Seoul | Seoul | 07301 | South Korea |
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| Plantar pressure summary feedback | Other | Experimental group, plantar pressure data are collected during each Lokomat session using instrumented insoles. After each session, session by session plantar pressure summary feed back and gait symmetry is provided to the participant to promote more symmetrical gait. The control group does not receive this plantar summary feedback. |
|
| ID | Term |
|---|---|
| D020521 | Stroke |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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