Robot Assisted Gait Training, Stroke
Conditions
Brief summary
Comparisons of Two Types of Robot Assisted Gait Training: Exoskeleton Type Robot vs. End-effector Type Robot: Randomized Controlled Trial
Interventions
DEVICEexoskeleton type robot
DEVICEend-effector type robot
Sponsors
National Rehabilitation Center, Seoul, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Hemiplegic patients secondary to first cerebrovascular accidents * Ankle dorsiflexor strength: medical research council scale 2 or 3 * Functional ambulation category score 3
Exclusion criteria
* History of surgery of affected lower limb * Fracture of affected lower limb
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Range of motion of ankle joint at 4 weeks | 4 weeks from baseline | ankle joint motion of sagittal plane during gait |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Berg Balance Scale | Baseline, 4 weeks from baseline, 8 weeks from 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) floolwing the guidelines of the test develpers, and the maximum score on this test is 56 which indicates balance ability within the normal range. |
| 10m walk test | Baseline, 4 weeks from baseline, 8 weeks from 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. |
| Fugl-Meyer Assessment | Baseline, 4 weeks from baseline, 8 weeks from 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. |
| Korean version of Falls efficacy scale | Baseline, 4 weeks from baseline, 8 weeks from 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 |
| Range of motion of hip joint | Baseline, 4 weeks from baseline, 8 weeks from baseline | Hip joint motion of sagittal plane during gait |
| Trunk impairment scale | Baseline, 4 weeks from baseline, 8 weeks from baseline | Trunk impairment scale performs to evaluate the sitting balance and trunk control ability examining static sitting balance, dynamic sitting balance, and coordination, and the maximum score on the subscales are 7, 10, and 6 points, repectively. The total score ranges from 0 to 23 points, a higher score indicating a better trunk performance. |
| Range of motion of ankle joint | Baseline, 8 weeks from baseline | ankle joint motion of sagittal plane during gait |
| Electromyography of lower extremities | Baseline, 4 weeks from baseline, 8 weeks from baseline | Muscle activity of tibialis anterior, medial gastrocnemius, vastus medialis, biceps femoris, gluteus medius during gait. |
| Plantar pressure | Baseline, 4 weeks from baseline, 8 weeks from baseline | Plantar pressure (great toe, little toe, medial meta, lateral meta, medial arch, lateral arch, heel) during gait |
| Step length, time | Baseline, 4 weeks from baseline, 8 weeks from baseline | Step length, stance time, swing time, and stride time during gait |
| Functional Ambulation Category | Baseline, 4 weeks from baseline, 8 weeks from 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 |
| Range of motion of knee joint | Baseline, 4 weeks from baseline, 8 weeks from baseline | knee joint motion of sagittal plane during gait |
Countries
South Korea
Contacts
Primary ContactJoon-Ho Shin, MS
Outcome results
None listed