Trial · NCT07880418
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Lower Extremity Strength Assessment | Baseline and immediately after the 5-week intervention | A handheld dynamometer will be used to assess lower extremity muscle strength. Participants will be informed about the test procedure before testing. Each test will be performed three times with maximal effort, and the mean value will be recorded in Newtons. The quadriceps femoris, hamstrings, hip flexors, hip extensors, hip adductors, and hip abductors will be evaluated. Each test will be repeated three times, with a 30-second rest period between measurements. When necessary, the therapist will stabilize the relevant extremity during testing. For the assessment of the quadriceps femoris, the participant will sit at the edge of a treatment table with the hip and knee flexed at 90°. The dynamometer will be placed approximately 1-2 cm proximal to the malleoli on the distal tibia. The participant will then be instructed to perform knee extension with maximal force, and the results of the three maximal trials will be recorded. |
| Primary | Upper Extremity Strength Assessment | Baseline and immediately after the 5-week intervention | The Jamar hand dynamometer will be used to assess upper extremity muscle strength. Participants will be seated in a chair with their back supported. The tested shoulder will be positioned in adduction, with the elbow flexed at 90°, while the forearm and wrist will be maintained in a neutral position. Prior to testing, participants will be informed about the procedure. The test will be performed three times with maximal effort, and the mean value will be recorded in kilograms. |
| Primary | Balance Assessment | Baseline and immediately after the 5-week intervention | The Berg Balance Scale (BBS) will be used to assess balance. The scale consists of 14 items, each scored from 0 (unable to perform) to 4 (normal performance). The test includes tasks such as forward reaching, standing with the eyes open and closed, and standing on one leg. A total score of 0-20 indicates a high level of balance impairment, 21-40 indicates a moderate level of balance impairment, and 41-56 indicates a low level of balance impairment. |
| Primary | Fatigue Assessment | Baseline and immediately after the 5-week intervention | The Fatigue Impact Scale (FIS) will be used to assess fatigue severity. The FIS is a self-report scale consisting of 40 items covering physical, psychosocial, and cognitive domains. Each item is scored from 0 (never) to 4 (almost always). The total score ranges from 0 to 160, with higher scores indicating a greater impact of fatigue on the individual. |
| Secondary | Quality of Life Assessment | Baseline and immediately after the 5-week intervention | The Multiple Sclerosis Quality of Life-54 (MSQOL-54) questionnaire, which is specifically designed for individuals with MS, will be used to assess quality of life. The questionnaire was developed based on the SF-36 Health Survey. In addition to the SF-36 items, 18 additional items assessing domains such as pain, cognitive function, and physical function were incorporated. The questionnaire consists of 54 items, and each domain is scored separately according to its specific scoring system. Scores range from 0 to 100, with higher scores indicating better quality of life. |
| Secondary | Mobility Assessment | Baseline and immediately after the 5-week intervention | The Multiple Sclerosis Walking Scale-12 (MSWS-12), specifically developed for individuals with multiple sclerosis (MS), will be used to assess walking ability and its limitations. The scale consists of 12 items rated on a 5-point Likert scale, ranging from 1 (not at all) to 5 (extremely). The items assess the impact of MS on walking ability, including walking distance, speed, balance, and the need for support. The raw total score ranges from 12 to 60, with higher scores indicating greater walking limitations. The raw score can be transformed to a 0-100 scale according to the instrument's scoring guidelines, with higher transformed scores also indicating greater walking impairment. |
| Secondary | Mobility Assessment | Baseline and immediately after the 5-week intervention | Another method that will be used to assess mobility is the Timed Up and Go (TUG) Test. Participants will be informed about the test procedure before testing. A distance of 3 meters will be marked between the chair and a designated turning point. The participant will sit in a chair with a backrest and armrests. Following the command "Go," the participant will stand up from the chair, walk 3 meters at their normal walking speed, turn around at the designated point, walk back 3 meters, and sit down in the chair again. The time required to complete the task will be recorded in seconds. A shorter completion time indicates better mobility. |
| Secondary | Cognitive Function Assessment | Baseline and immediately after the 5-week intervention | The Brief International Cognitive Assessment for MS (BICAMS) is a brief assessment battery specifically developed for individuals with MS to evaluate cognitive function. It consists of three subtests: the Symbol Digit Modalities Test (SDMT), the California Verbal Learning Test-Second Edition (CVLT-II), and the Brief Visuospatial Memory Test-Revised (BVMT-R). Participants will be informed about the procedures for each subtest before the assessment. |
| Secondary | Cognitive Function Assessment | Baseline and immediately after the 5-week intervention | The Symbol Digit Modalities Test (SDMT) is used to assess information-processing speed and consists of nine digits and nine corresponding symbols. Participants are required to write the digits corresponding to the presented symbols as quickly and accurately as possible within 90 seconds. Following one practice trial, the test will be administered. The numbers of correct and incorrect responses will be recorded. |
| Secondary | Cognitive Function Assessment | Baseline and immediately after the 5-week intervention | The California Verbal Learning Test-Second Edition (CVLT-II) is used to assess verbal-auditory learning and memory. The test consists of 16 words representing categories such as vegetables, household items, animals, and vehicles. The examiner will read the 16 words aloud in a clear and audible voice five consecutive times. After each presentation, participants will be asked to recall as many words as possible, and the recalled words will be recorded. A maximum of 80 words can be recalled across the five trials. The test will be administered without a time limit, and the numbers of correct and incorrect responses will be recorded. |
| Secondary | Cognitive Function Assessment | Baseline and immediately after the 5-week intervention | The Brief Visuospatial Memory Test-Revised (BVMT-R) requires participants to examine six geometric figures for 10 seconds and subsequently reproduce the figures from memory on a separate sheet of paper. Each figure will be scored according to both its accuracy and spatial location: 2 points will be awarded if the figure and its location are reproduced correctly, 1 point if the location is correct but the figure is only approximately reproduced, and 0 points if the figure cannot be reproduced. A maximum of 12 points can be obtained per trial. The test will be repeated three times, and the total score will be calculated. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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