Cortical Activity and Gait Function for Robotic Gait Training in Hemiparetic Stroke
Study Details
Study Description
Brief Summary
Effects of robot-assisted gait training on cortical activity and gait function in hemiparetic stroke
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Robot-assisted gait training experimental group that applied the end-effector robot-assisted gait training |
Device: Robot-assisted gait training
intervention with robot-assisted gait training
|
| Active Comparator: Treadmill gait training control group that applied the treadmill gait training |
Device: Treadmill gait training
intervention with treadmill gait training
|
Outcome Measures
Primary Outcome Measures
- oxygenated hemoglobin levels [4 weeks from baseline]
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
- Range of motion of ankle, knee, and hip joint [4 weeks from baseline]
ankle, knee, and hip joint motion of sagittal plane during gait
Secondary Outcome Measures
- oxygenated hemoglobin levels [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
- Range of motion of ankle, knee, and hip joint [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]
ankle, knee, and hip joint motion of sagittal plane during gait
- Berg Balance Scale [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]
Berg Balance Scale assess the functional balance ability of participants with observation of 14 tasks, representing functional movements common in daily life. Each task is scored on a five-point scale (0-4) following the guidelines of the test developers, and the maximum score on this test is 56 which indicates balance ability within the normal range.
- Fugl-Meyer Assessment [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]
Fugl-Meyer Assessment uses to examine the motor function and coordination of affected lower extremity. It includes 17 items of a 3-point ordinal scale, ranging 0-34, with higher scores indicating lower impairment.
- 10m walk test [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]
10m walk test is used to examine gait speed, in which participant was asked to walk on a 14 meter of walkway wearing harness with two conditions; with the fastest speed or with self-selected comfortable speed.
- Functional ambulation category [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]
Functional Ambulation Category is used to assess gait ability with 6 levels ranging from 0 to 5 on the basis of the amount of physical support required, regardless of use of an assistive device
- Falls efficacy scale [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]
Korean version of Falls efficacy scale asks subjects to rank their confidence about their ability not to fall while performing a variety of activities of daily living with a maximum score of 100
- Beck depression inventory [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]
21-question multiple-choice self-report inventory, one of the most widely used psychometric tests
- Stroke impact scale [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]
health-related quality of life poststroke across 8 domains using a 5-point Likert scale, with the score ranging from 0 to 100 and a higher score indicating better health status
- Dynamic gait index [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]
a clinical tool to assess gait, balance and fall risk
- Timed up and go test [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]
a simple test used to assess a person's mobility and requires both static and dynamic balance
- modified Barthel index [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]
Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients
- dual task - COWAT [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]
Controlled Oral Word Association Test, abbreviated COWA or COWAT, is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter.
- dual task - digit span test [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]
The digit span test is a way of measuring the storage capacity of a person's working memory.
- Electromyography of lower extremities [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]
Muscle activity of tibialis anterior, medial gastrocnemius, vastus medialis, biceps femoris, gluteus medius during gait.
- Plantar pressure [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]
Plantar pressure (great toe, little toe, medial meta, lateral meta, medial arch, lateral arch, heel) during gait
- Spatiotemporal gait parameter data [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]
step length, step time, swing time, double limb support time during gait
- deoxygenated hemoglobin levels [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
- total hemoglobin levels [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
- Balance test using force plate [baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline]
Static standing balance as measured using a force plate: Changes in center-of-pressure velocity and area
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Hemiplegic patients secondary to first cerebrovascular accidents
-
Functional ambulation category score 3
-
3 months ≤ Onset ≤ 12 months
-
Korean Mini-Mental State Examination score > 24
Exclusion Criteria:
-
History of surgery of affected lower limb
-
Fracture of affected lower limb
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Rehabilitation Center | Seoul | Korea, Republic of | 142884 |
Sponsors and Collaborators
- National Rehabilitation Center, Seoul, Korea
Investigators
- Principal Investigator: Joon-Ho Shin, MS, National Rehabilitation Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NRC-2017-02-015