Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
The change of stride length (meter) of parameters of gait cycle. |
The primary outcome was the stride length (meter) of parameters of gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis. |
The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study. |
|
Primary |
The change of cadence(step/min) of parameters of gait cycle |
The primary outcome was the cadence(step/min) of parameters of gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis. |
The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study. |
|
Primary |
The change of duration of stance phase(%) of parameters of gait cycle |
The primary outcome was the duration of stance phase(%) of parameters of gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis. |
The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study. |
|
Primary |
The change of duration of swing phase(%) of parameters of gait cycle |
The primary outcome was the duration of swing phase(%) of parameters of gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis. |
The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study. |
|
Primary |
The change of duration of single support (%) of parameters of gait cycle |
The primary outcome was the duration of single support (%) of parameters of gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis. |
The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study. |
|
Primary |
The change of double support (%)during the gait cycle |
The primary outcome was the double support (%)during the gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis. |
The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study. |
|
Primary |
The change ofangle between toes and the ground at the time of toe-off during a gait cycle (toe-off angle) |
The primary outcome was the angle between toes and the ground at the time of toe-off during a gait cycle (toe-off angle). The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis. |
The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study. |
|
Primary |
The change ofangle between calcaneus and the ground at the time of heel-strike during a gait cycle (heel-strike angle) |
The primary outcome was the angle between calcaneus and the ground at the time of heel-strike during a gait cycle (heel-strike angle). The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis. |
The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study. |
|
Secondary |
The Berg balance scale (BBS) |
The Berg balance scale (BBS) is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. It is used to objectively determine a patient's ability to safely balance during a series of predetermined tasks. The higher the score means the better ability to maintain the balance. A score of less than 45 indicates individuals may be at greater risk of falling. Studies of various populations and stroke patients have shown high intra-rater and inter-rater reliability (intraclass correlation coefficient [ICC]=0.98 and 0.97, respectively). BBS has been reported that in the elderly population a change of 4 points is needed to be 95% confident that true change has occurred if a patient scores within 45-56 initially, 5 points if they score within 35-44, 7 points if they score within 25-34 and, finally, 5 points if their initial score is within 0-24 on the Berg Balance Scale. |
The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study. |
|
Secondary |
Barthel index (BI) |
Barthel index (BI) measures the degree of assistance required by an individual on 10 items of mobility and self-care Activity of daily living, including feeding, dressing, grooming, bathing, bowels, bladder, toilet use, transfers, mobility, and stairs. The total scores ranges from 0 to 100. The higher the score means the better of the function. BI has been shown to have portability and has been used in 16 major diagnostic conditions. Studies has demonstrated high inter-rater reliability (0.95) and test-retest reliability (0.89) as well as high correlations (0.74-0.8) with different physical disabilities. |
The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study. |
|
Secondary |
Timed up and go test (TUG) |
Timed up and go test (TUG) is designed for determining fall risk and measuring the progress of balance, sit to stand, and walking. To perform the test, participant starts in a seated position (50 cm from the floor), stands up upon therapist's command to walk 3 meters, then turn around, walk back to the chair and sit down. The time stops when the patient is seated. If a community dwelling older adults takes 14 seconds or longer, the risk for falling is high. The TUG showed excellent reliability (ICC>0.95) in chronic stroke patients. |
The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study. |
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