Trial · NCT05459584
Robotic Assisted Rehabilitation for Balance and Gait in Orthopedic Patients.
NCT05459584, Not applicable, Completed, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Robotic Assisted Rehabilitation for Balance and Gait in Orthopedic Patients. Trials, record NCT05459584. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05459584
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Robotic Assisted Rehabilitation for Balance and Gait in Orthopedic Patients.
- NCT number
- NCT05459584
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 24 participants, actual
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip, Gait Disorders in Old Age, Balance; Distorted
- Interventions
- Technological Rehabilitation
- First posted
- 2022-07-15
- Last updated
- 2024-01-24
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Berg Balance Scale (BBS) | Change from Baseline Ambulation Index at 4 weeks | The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It 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 and takes approximately 20 minutes to complete. It does not include the assessment of gait. |
| Secondary | Motricity Index (MI) | Change from Baseline Ambulation Index at 4 weeks | The Motricity Index can be used to assess the motor impairment in a patient who has had a stroke. Test for each leg: (1) ankle dorsiflexion with foot in a plantar flexed position 14 points are given if there is less than a full range of dorsiflexion (2) knee extension with the foot unsupported and the knee at 90° 14 points are given for less than 50% of full extension 19 points are given for full extension yet it can be easily pushed down (3) hip flexion with the hip bent at 90° moving the knee towards the chin 14 points are given if there is less than a full range of passive motion 19 points are given if the hip is fully flexed yet it can be easily pushed down. Interpretation: minimum score: 0 maximum score: 100 |
| Secondary | Timed Up and Go Test (TUG) | Change from Baseline Ambulation Index at 4 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. |
| Secondary | Knee Injury and Osteoarthritis Outcome Score - Italian Version (KOOS-I) | Change from Baseline Ambulation Index at 4 weeks | KOOS-I is a self-administered questionnaire of 42 items and 5 sub-scales investigating different aspects: Symptoms (7 items, 2 inherent to stiffness); Pain (9 items); Functions and activities of daily living (17 items); Sports and recreation (5 items); and Quality of life in relation to the knee (4 items). All Scale Items present the same response mode by making use of a 5-point Likert scale ranging from 0 (no problems or difficulties) to 4 (high problems or difficulties). |
| Secondary | Hip disability and Osteoarthritis Outcome Score - Italian version (HOOS-I) | Change from Baseline Ambulation Index at 4 weeks | HOOS-I is a self-administered questionnaire designed to assess reported symptoms at the hip joint level in subjects with or without primary osteoarthritis and following hip arthroplasty surgery. HOOS-I consists of 40 items divided into 5 subscales that assess five distinct dimensions relevant to the patient: Symptoms (3 items on symptoms and 2 on stiffness); Pain (10 items); Activities of Daily Living (ADL) (17 items); Physical function, sports and leisure activities (4 items); Quality of life (4 items). The patient has to express his/her opinion through standardized response options based on the 5-point Likert scale (none, mild, moderate, severe, extreme); each response is assigned a score ranging from 0 (no problem) to 4 (extreme problems). |
| Secondary | Ambulation Index (AI) | Change from Baseline Ambulation Index at 4 weeks | The Ambulation Index is a rating scale to assess mobility by evaluating the time and degree of assistance required to walk 8 meters. Scores range from 0 (asymptomatic and fully active) to 10 (bedridden). The patient is asked to walk a marked 8 meters course as quickly and safely as possible. The examiner records the time and type of assistance (e.g., cane, walker, crutches) needed. Although the patient's walking is timed, the time is not used directly but is utilized in conjunction with other factors to rate the patient on an ordinal scale with 11 gradations. 0 = Asymptomatic; fully active. 10 = Bedridden |
| Secondary | Walking handicap scale (WHS) | Change from Baseline Walking handicap scale at 4 weeks | The Walking handicap scale (WHS) is an assessment tool that allows us to evaluate the quality of walking in the home and social environment through a a scale comprising six categories. 1 = Physiological walking: walking only as exercise 6 = Unrestricted walking in social settings: independent in all activities, on uneven ground, in crowded places, shows complete independence in public places |
| Secondary | Functional Ambulation Classification (FAC) | Change from Baseline Functional Ambulation Classification at 4 weeks | The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. To use the FAC, an assessor asks the subject various questions and briefly observes their walking ability to provide a rating from 0 to 5. A score of 0 indicates that the patient is a non-functional ambulator (cannot walk); A score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3). A score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score). |
| Secondary | 10 Meter Walk Test (10mWT) | Change from Baseline 10 Meter Walk Test at 4 weeks | The 10mWT is used to assess walking speed in meters/second (m/s) over a short distance. The total time taken to ambulate 6 meters (m) is recorded to the nearest hundredth of a second. 6 m is then divided by the total time (in seconds) taken to ambulate and recorded in m/s. The time is measured for the middle 6 m to allow for patient acceleration and deceleration. The time is started when any part of the leading foot crosses the plane of the 2-m mark. The time is stopped when any part of the leading foot crosses the plane of the 8-m mark.1 The time to walk the middle 6m, the level of assistance, and type of assistive device and/or bracing used will be documented. If a patient requires total assistance or is unable to ambulate at all, a score of 0 m/s will be documented. |
| Secondary | Six-Minute Walk test (6MWT) | Change from Baseline 10 Meter Walk Test at 4 weeks | The six-minute walk test (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. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests4
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 |
|---|---|---|
| Cancellation Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
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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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05459584
GET https://conductscience.org/api/trials/v1/NCT05459584/registered