Trial · NCT07898098
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mobility of lower-limb prosthesis users: PLUS-M™ 12-Item Short Form T-score | Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up). | Mobility of lower-limb prosthesis users is assessed using the Prosthetic Limb Users Survey of Mobility (PLUS-M™) 12-Item Short Form (v1.2). The questionnaire consists of 12 items assessing the participant's ability to perform various mobility-related activities. Each item is rated on a 5-level response scale. The responses are scored according to the PLUS-M™ scoring procedure to obtain a standardized PLUS-M™ T-score. The raw score is used only to determine the corresponding T-score. Higher T-scores indicate greater mobility. Unit of Measure: PLUS-M™ T-score |
| Secondary | Health-related quality of life: EQ-5D-5L index score | Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up). | Health-related quality of life is assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The questionnaire assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-level scale ranging from 1 (no problems) to 5 (extreme problems or unable to perform the activity, as applicable). The responses across the five dimensions are converted into a single EQ-5D-5L index score using the German EQ-5D-5L value set (Ludwig et al., 2018). Unit of Measure: EQ-5D-5L index score |
| Secondary | Health-related quality of life: EQ Visual Analogue Scale (EQ VAS) score | Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up). | Self-rated health status is assessed using the EQ Visual Analogue Scale (EQ VAS) of the EQ-5D-5L questionnaire. Participants rate their current health status on a visual analogue scale ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine). Unit of Measure: EQ VAS score (0-100) |
| Secondary | Reintegration into normal living: Reintegration to Normal Living Index (RNLI) total score | Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up). | Reintegration into normal living is assessed using the 11-item Reintegration to Normal Living Index (RNLI). The questionnaire assesses the participant's perceived ability to participate in and manage activities, roles, and relationships in daily life. Each item is rated on a 10-point scale ranging from 0 (does not describe my situation at all) to 10 (describes my situation perfectly). The scores of the 11 items are summed to obtain a total RNLI score ranging from 0 to 110 points. Higher scores indicate greater reintegration into normal living. Unit of Measure: RNLI total score (0-110 points) |
| Secondary | Locomotor capabilities: Locomotor Capabilities Index-5 (LCI-5) total score | Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up). | Locomotor capabilities with a lower-limb prosthesis are assessed using the Locomotor Capabilities Index-5 (LCI-5). The questionnaire consists of 14 items assessing the participant's ability to perform basic and advanced locomotor activities while using a prosthesis. Each item is scored from 0 (not able to perform the activity) to 4 (able to perform the activity independently without walking aids). Item scores are summed to obtain the total LCI-5 score. Higher scores indicate greater locomotor capability. Unit of Measure: LCI-5 total score (0-56 points) |
| Secondary | Independence in activities of daily living: Barthel Index total score | Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up). | Independence in activities of daily living is assessed using the Barthel Index. The assessment covers 10 activities of daily living. Individual activities are scored according to the Barthel Index scoring procedure and combined to obtain a total Barthel Index score. Higher scores indicate greater independence in activities of daily living. Unit of Measure: Barthel Index total score (0-100 points) |
| Secondary | Functional mobility: Timed Up and Go (TUG) test completion time | Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation). | Functional mobility is assessed using the Timed Up and Go (TUG) test. The participant starts in a seated position, stands up, walks 3 meters, turns around, walks back, and sits down. The time required to complete the test is measured from initiation of the movement until the participant returns to the seated position. Unit of Measure: Seconds |
| Secondary | Falls: number of falls | Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up). | The occurrence of falls is assessed using a study-specific fall survey. The number of falls experienced by the participant during the specified assessment period is recorded. Unit of Measure: Number of falls |
| Secondary | Fear of falling: Numerical Rating Scale (NRS) score | Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up). | Fear of falling is assessed using a numerical rating scale (NRS) included in the study-specific fall survey. The participant rates their fear of falling on the NRS. Unit of Measure: NRS score |
| Secondary | Residual limb wound healing: Pressure Ulcer Scale for Healing (PUSH) total score | Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation). | Residual limb wound healing is assessed using the Pressure Ulcer Scale for Healing (PUSH). The PUSH assesses three wound characteristics: wound surface area, wound exudate, and wound tissue type. Wound surface area is determined by measuring the maximum wound length and width and calculating length × width. The resulting wound area is categorized and scored from 0 to 10 points. Wound exudate is categorized as none, scant, moderate, or heavy and scored from 0 to 3 points. Wound tissue type is categorized and scored from 0 to 4 points. The three component scores are summed to obtain a total PUSH score ranging from 0 to 17 points. Unit of Measure: PUSH total score (0-17 points) |
| Secondary | Functional mobility: Amputee Mobility Predictor with Prosthesis (AMPPRO) total score | Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation). | Functional mobility of lower-limb prosthesis users is assessed using the Amputee Mobility Predictor with Prosthesis (AMPPRO). The AMPPRO is a 21-item performance-based assessment evaluating sitting and standing balance, transfers, gait initiation, gait pattern, turning, variable cadence, obstacle negotiation, stair negotiation, and use of walking aids. Individual item scores are combined according to the AMPPRO scoring procedure to obtain a total AMPPRO score ranging from 0 to 47 points. Higher scores indicate better functional mobility. Unit of Measure: AMPPRO total score (0-47 points) |
| Secondary | Walking capacity: 2-Minute Walk Test distance | Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation). | Walking capacity is assessed using the 2-Minute Walk Test (2MWT). The distance walked by the participant during 2 minutes is measured. Unit of Measure: Meters (m) |
| Secondary | Walking capacity: 6-Minute Walk Test distance | Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation). | Walking capacity is assessed using the 6-Minute Walk Test (6MWT). The distance walked by the participant during 6 minutes is measured. Unit of Measure: Meters (m) |
| Secondary | Phantom limb pain intensity | Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation). | Phantom limb pain intensity is assessed during clinical examination using a numerical rating scale (NRS). The participant rates the intensity of phantom limb pain. Unit of Measure: NRS score (0-10) |
| Secondary | Residual limb pain intensity | Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation). | Residual limb pain intensity is assessed during clinical examination using a numerical rating scale (NRS). The participant rates the intensity of pain experienced in the residual limb. Unit of Measure: NRS score (0-10) |
| Secondary | Other pain intensity | Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation). | Pain other than phantom limb pain or residual limb pain is assessed during clinical examination using a numerical rating scale (NRS). The location and description of the pain are documented, and the participant rates its intensity. Unit of Measure: NRS score (0-10) |
| Other | Residual limb shape | Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation). | The shape of the lower-limb residual limb is assessed and documented during clinical examination according to predefined clinical categories. Unit of Measure: Categorical assessment |
| Other | Prosthesis characteristics: study-specific prosthesis questionnaire | Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up). | Characteristics of the participant's lower-limb prosthesis are documented using a study-specific prosthesis questionnaire. The questionnaire records predefined prosthesis characteristics and prosthetic components. Unit of Measure: type of prosthetic foot |
| Other | Changes in prosthesis: study-specific prosthesis questionnaire | 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up). | Changes to the participant's lower-limb prosthesis and prosthetic components during the study are documented using a study-specific prosthesis questionnaire. Unit of Measure: number of prosthetic component changes |
| Other | Residual limb length | Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation). | The length of the lower-limb residual limb is measured during clinical examination. Unit of Measure: Centimeters (cm) |
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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