Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Five Times Sit to Stand Test (5TSST) |
A chair without armrests, with a 28.5 cm deep seat and backrest and adjustable height is used for the tests. Subjects start in a seated position, with their arms in the desired position and their backs against the chair backrest. The following verbal instructions are given: "Please stand up and sit down 5 times as quickly as possible. Straighten your knees when standing up and lean your back against the backrest when sitting down." Timing with the digital stopwatch is started manually with the instruction "Start" and stopped when the subject's back touches the backrest after the fifth standing up. |
Change from Baseline 5TSST at 8 weeks |
|
| Primary |
Cognitive Timed Up and Go Test (CTUG) |
Patients are first asked to stand up from a sitting position, walk 3 m at their normal speed, turn around, walk back to the chair and sit down. Walking aids are allowed. Patients are asked to perform this test while performing a cognitive dual task (subtract 2 continuously starting from 100). |
Change from Baseline CTUG at 8 weeks |
|
| Primary |
Dual-Task Questionnaire (DTQ) |
The questionnaire consists of 10 items and each question is rated out of 5 points (ranging from 0 "never" to 4 "very often" or N/A "not applicable"). The score obtained is the average score per question (i.e. total score/10 for the questionnaire). |
Change from Baseline DTQ at 8 weeks |
|
| Primary |
Activity Specific Balance Confidence Scale (ABC) |
This scale includes 16 tasks related to indoor and outdoor activities of daily living to measure balance confidence in older people with various levels of function. Scores for each question range from 0% (no confidence) to 100% (full confidence). Higher scores indicate greater confidence. |
Change from Baseline ABC at 8 weeks |
|
| Primary |
Visual Analog Scale (VAS) |
On a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain). |
Change from Baseline VAS at 8 weeks |
|
| Primary |
Harris Hip Score (HHS) |
The HHS contains 12 questions covering four domains: pain (44 points); function (47 points); deformity; and range of motion (9 points). This questionnaire was developed to assess the outcomes of young and middle-aged patients following hip arthroscopic debridement. Each question is answered using a Likert scale with an overall score ranging from 0 (extreme symptoms) to 100 (no symptoms). |
Change from Baseline HHS at 8 weeks |
|
| Primary |
Mini-Mental State Examination (MMSE) |
The mini mental test is categorized under five main headings: orientation (10 points), recording memory (3 points), attention and calculation (5 points), recall (3 points) and language (9 points). The scale is scored out of a total of 30 points and has two different variants for educated and uneducated people. Traditionally, scores between 24 and 30 are considered normal. A score below 24 indicates cognitive impairment. 18-23 is considered as mild dementia, 12-17 as moderate dementia and below 12 as severe dementia. |
Change from Baseline MMSE at 8 weeks |
|
| Primary |
Lower-Extremity Motor Coordination Test (LEMOCOT) |
The test requires subjects seated in a chair to alternately touch a proximal and distal target placed 30 cm apart on the floor with their feet within a 20-second period. A higher score indicates better motor coordination. |
Change from Baseline LEMOCOT at 8 weeks |
|
| Primary |
4-Meter Gait Speed (4MGS) |
Walking speed is assessed over two trials using a stopwatch in a long corridor over a distance of 4 meters during a single testing session, with one trial performed immediately after the other. Participants start ambulating approximately two meters before the start of the timed 4-meter walk and stop ambulating approximately two meters after completing the 4-meter walk. Timing begins and ends when the participants' lead foot crosses the start and end points of the 4-meter walk, respectively. Participants are instructed to walk at their normal safe walking speed and are allowed to use an assistive device if needed. The time taken to complete the two ambulation trials is recorded for analysis. Walking speed is calculated as the distance walked (4 meters) divided by the time taken to complete the 4-meter walk. The average walking speed for the two trials is calculated. |
Change from Baseline 4MGS at 8 weeks |
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