Cognitive-motor Technology Rehabilitation in Frail Individuals
NCT07292428, Not applicable, Recruiting, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Cognitive-motor Technology Rehabilitation in Frail Individuals | ClinicalTrials.gov |
| NCT number | NCT07292428 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 80 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | ClinicalTrials.gov |
| Conditions | Frail, Sensorimotor Deficits | ClinicalTrials.gov |
| Interventions | Technological rehabilitation with robotic platfom and home telerehabilitation device, Conventional rehabilitation | ClinicalTrials.gov |
| First posted | 2025-12-18 | ClinicalTrials.gov |
| Last updated | 2026-02-03 | ClinicalTrials.gov |
Registered outcomes 17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Dual-Task Cost (DTC) | Change from Baseline DTC at 8 weeks | DTC refers to the deterioration in performance in one or both tasks when two tasks are performed simultaneously compared to when they are performed individually. This cognitive cost manifests itself as a reduction in speed, accuracy or quality in task performance, and can be measured by comparing individual performance with that achieved in "dual task" mode. Specifically, DTC is calculated as the difference between the displacement of the centre of pressure during a cognitive task and the displacement of the centre of pressure during a single-task activity with eyes open, divided by the displacement of the centre of pressure during a single-task activity with eyes open. Higher DTC values correspond to a deterioration in performance. | ClinicalTrials.gov |
| Secondary | Hand Grip Strength Test (HSGT) | Change from Baseline HGST at 8 weeks | HGST is a test performed with a dynamometer, which goes to assess muscle strength (in kilograms). Starting with the elbow flexed to 90° the patient must squeeze the dynamometer as hard as they can at one time. Three repeated measurements are taken on each side 20 seconds apart. The average of the three assessments is used as the final value. | ClinicalTrials.gov |
| Secondary | Short Physical Performance Battery (SPPB) | Change from Baseline SPPB at 8 weeks | SPPB is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults (\>65 years of age). Three domains, which include balance, usual or self-selected gait speed, and lower limb strength, are assessed by a three-stage balance test (feet side-by-side, semitandem, and tandem positions), a 3-m or 4-m gait speed test (time spent to walk the course), and a repetitive chair stand test (five times chair sit-to-stand test), respectively. A 0- to 12-point scale is used to score the sum of the three assessments with higher point values corresponding with greater levels of physical function and lower disability, whereas lower point values correspond with lower levels of physical function and higher disability, respectively. | ClinicalTrials.gov |
| Secondary | Timed Up and Go Test (TUG) | Change from Baseline TUG at 8 weeks | The Timed Up and Go test (TUG) measures in seconds the time it takes a subject to rise from a chair, walk a distance of 3 meters, turn, walk back to the chair and sit down. The performance is rated on a scale of 1 to 5 (where 1 is normal and 5 is severely abnormal) according to the observer's perception of the patient's risk of falling. The timed part of the test records the mean time (in seconds) from initial getting up to re-seating. Patients are compared with the mean time of adults in their age group, 60 to 69, 70 to 79, and 80 to 99 years of age. | ClinicalTrials.gov |
| Secondary | Six-minute walk test (6MWT) | Change from Baseline 6MWT at 8 weeks | The 6MWT is a sub-maximal exercise test used to assess walking endurance and aerobic capacity. Participants will walk around the perimeter of a set circuit for a total of six minutes. The score of the test is the distance a patient walks in 6 minutes (measured in meters and can round to the nearest decimal point). Distance (in meters) covered in six minutes is calculated by multiplying the number of total laps by 12 meters and adding the distance of the partial lap completed at the time the test ended. | ClinicalTrials.gov |
| Secondary | Timed-25 Foot Walk (T25FW) | Change from Baseline T25FW at 8 weeks | The T25FW is a quantitative mobility and leg function performance test based on a timed 25-foot walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. | ClinicalTrials.gov |
| Secondary | Silver Index (SI) | Change from Baseline SI at 8 weeks | The SI is an objective test to identify the risk of falling, which is carried out using the Hunova robotic platform. It consists of seven domains: (i) static balance (ii) dynamic balance (iii) reactive balance (iv) sensory integration (v) stability limits (vi) sitting-to-standing position (vii) gait speed. At the end of the evaluation you get a percentage that indicates the risk of falling: higher percentages correspond to a higher risk of falling. | ClinicalTrials.gov |
| Secondary | Trial Making Test (TMT) | Change from Baseline TMT at 8 weeks | The Trail Making Test (TMT) measures flexibility of thinking on a visual-motor sequencing task. It consists of two parts, A and B, where 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). Results for both TMT A and B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Trail A: Average 29 seconds, Deficient \> 78 seconds, Rule of Thumb Most in 90 seconds Trail B: Average 75 seconds, Deficient \> 273 seconds, Rule of Thumb Most in 3 minutes. | ClinicalTrials.gov |
| Secondary | Symbol Digit Modalities Test (SDMT) | Change from Baseline SDMT at 8 weeks | The Symbol Digit Modalities Test (SDMT) is a test that assesses information processing speed and consists of a series of nine printed symbols to which nine numbers correspond. After a 'training' phase, patients are asked to match as many symbols as possible to the corresponding number in just 90 seconds. As the test persons can give written or oral answers, the test is suitable for people with motor disabilities or speech disorders. The score is calculated by adding up the number of correct substitutions in the 90-second interval (maximum = 110). Interpretation results from normalising the categories of gender, age and education. | ClinicalTrials.gov |
| Secondary | Stroop Colour Word Test (SCWT) | Change from Baseline SCWT at 8 weeks | The Stroop Color and Word Test (SCWT) is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. The subject is asked to read the words in the first task, to name colors in the second and third tasks. It is necessary to mark both any mistakes made but also the time spent on each task. The cut-off for the error interference effect is 4.24, while the cut-off for the time interference effect is 36.92. | ClinicalTrials.gov |
| Secondary | Modified Fatigue Impact Scale (MFIS) | Change from Baseline MFIS at 8 weeks | The Modified Fatigue Impact Scale (MFIS) is an instrument that provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The full-length MFIS consists of 21 items while the abbreviated version has 5 items. The MFIS is a structured, self-report questionnaire that the patient can generally complete with little or no intervention from an interviewer. However, patients with visual or upper extremity impairments may need to have the MFIS administered as an interview. Interviewers should be trained in basic interviewing skills and in the use of this instrument. The total score for the MFIS is the sum of the scores for the 21 items. Individual subscale scores for physical, cognitive, and psychosocial functioning can also be generated by calculating the sum of specific sets of items. | ClinicalTrials.gov |
| Secondary | EuroQoL- 5D (EQ-5D) | Change from Baseline EQ-5D at 8 weeks | EQ-5D is an instrument which evaluates the generic quality of life. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to ED-5D permit to find 243 unique health states or can be converted into EQ- 5D index an utility scores anchored at 0 for death and 1 for perfect health. | ClinicalTrials.gov |
| Secondary | Hospital Anxiety and Depression Scale (HADS) | Change from Baseline HADS at 8 weeks | The Hospital Anxiety and Depression Scale (HADS) is a tool used to check for symptoms of anxiety and depression, especially in hospital patients. It has 14 questions, 7 for anxiety and 7 for depression. Each question is scored from 1 to 4. | ClinicalTrials.gov |
| Secondary | Pittsburgh Sleep Quality Index (PSQI) | Change from Baseline PSQI at 8 weeks | The PSQI is a sleep quality assessment scale that considers the last month; it consists of 19 items that must be assessed by the subject themselves and another 5 that must be completed by their bed or room partner (which are not included in the total score, but serve only as clinical information). In calculating the PSQI score, seven composite scores are derived (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of hypnotic medications, daytime disturbances), each with a score from 0 (no difficulty) to 3 (severe difficulty). The scores for the 7 domains are added together to produce an overall score (from 0 to 21). Higher scores indicate poorer sleep quality. | ClinicalTrials.gov |
| Secondary | Bioimpedance analysis (BIA) | Change from Baseline BIA at 8 weeks | BIA measures phase angle (PhA), which is related to cellular health and muscle quality. Lower PhA values have typically been observed in individuals with serious medical conditions and have been linked to poorer outcomes; conversely, higher PhA values are indicative of better overall health, strength, and muscle function. | ClinicalTrials.gov |
| Secondary | SARC-F | Change from Baseline SARC-F at 8 weeks | The SARC-F is a simple screening tool used to identify individuals at risk of sarcopenia. It consists of 5 questions assessing strength, assistance with walking, rising from a chair, climbing stairs, and falls. Each item is scored from 0 to 2, with a total score ranging from 0 to 10. A score of 4 or higher suggests a risk of sarcopenia and the need for further assessment. | ClinicalTrials.gov |
| Secondary | Mini Nutritional Assessment- short Form (MNA-SF) | Change from Baseline MNA-SF at 8 weeks | The Mini Nutritional Assessment - Short Form (MNA-SF) is a screening tool used to quickly evaluate the risk of malnutrition in older adults. It consists of 6 questions covering aspects such as weight loss, appetite, mobility, psychological stress, and body mass index (BMI) or calf circumference. Scores range from 0 to 14, with 12-14 indicating normal nutrition, 8-11 at risk of malnutrition, and 0-7 indicating malnutrition. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)