Robotic Assisted Rehabilitation for Balance and Gait in Orthopedic Patients.
NCT ID: NCT05459584
Last Updated: 2024-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
24 participants
INTERVENTIONAL
2022-08-01
2023-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
In Italy, in 2002 it was estimated that 28.6% of people over 65 years fall within a year: of these, 43% fall more than once and 60% of falls occur at home. Such falls can often result in fractures leading to the need for hospitalization with significant impact on both motor and cognitive function. Balance and gait rehabilitation are of primary importance for the recovery of a person's autonomy and independence, especially in older individuals who have undergone osteosynthesis or prosthesis surgery of the lower limbs. Technological and robotic rehabilitation allows for greater intensity, objectivity, and standardization in treatment protocols, as well as in outcome measurement. In this context, patient motivation is fuelled and maintained by both the sensory stimuli that support technological treatment and the challenge of achieving ever better results, objective feedback from instrumental assessments. Osteoarthritic patients who have undergone osteosynthesis or lower extremity prosthetic surgery require special attention, especially with the goal of preventing further accidents and reducing the patient's risk of falling.
Given these considerations, it is believed that conventional physical therapy combined with technological balance treatment may be more effective on rehabilitation outcome than conventional therapy alone.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Smart Kneebrace for Continuous Monitoring of Joint Angles During Rehabilitation
NCT03365284
Static and Dynamic Balance in Correlation With Quality of Life, in Primary Total Knee Replacement
NCT00256958
Digital Biofeedback System Versus Conventional Home-based Rehabilitation After Total Hip Replacement
NCT03045549
Efficacy of Robot-assisted Technique vs Conventional Technique in Preventing Early Micromobilisation After UKA
NCT05204797
Evaluation of Robot-assisted Total Knee Arthroplasty with Automatic Balancing
NCT04724915
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental: Technological Group
Technological group (TG) patients will undergo robotic treatment for the improvement balance through the robotic platform (Hunova® Movendo Technology srl, Genova, IT), 3 times per week for 45 minutes each, in addition to the conventional treatment (total 180 minutes per day). In particular, the technological rehabilitation performed employing a footboard will be mostly aimed at improving the balance both in sitting and standing position, and will be proposed static and dynamic exercises, exercises dual-task exercises, and exercises to improve trunk control.
Technological Rehabilitation
Specific rehabilitation for balance disorder using the robotic platform
No Intervention: Control Group
Congrol Group (CG) patients will undergo conventional rehabilitation treatment only, using the main rehabilitation methods (e.g., neurocognitive theory, Bobath Concept, Progressive neuromuscular facilitation, etc.).
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Technological Rehabilitation
Specific rehabilitation for balance disorder using the robotic platform
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with outcomes of surgery for prosthetic hip or knee replacement;
* Latency from the acute event between 15 days and 3 months;
* Cognitive abilities to execute simple orders and understand the physical therapist's directions \[assessed by Token Test (score ≥26.5)\];
* Ability to walk independently or with little assistance;
* Ability to understand and sign informed consent.
Exclusion Criteria
* Presence of oncological pathologies;
* Presence of plantar ulcers;
* Partial or total amputation of foot segments.
55 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
GIOVANNINI SILVIA
Researcher
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Silvia Giovannini, MD, phD
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitaria A. Gemelli IRCCS
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
R Core Team (2021). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL https://www.R-project.org/.
Alessandri G, Zuffiano A, Perinelli E. Evaluating Intervention Programs with a Pretest-Posttest Design: A Structural Equation Modeling Approach. Front Psychol. 2017 Mar 2;8:223. doi: 10.3389/fpsyg.2017.00223. eCollection 2017.
Aprile I, Iacovelli C, Padua L, Galafate D, Criscuolo S, Gabbani D, Cruciani A, Germanotta M, Di Sipio E, De Pisi F, Franceschini M. Efficacy of Robotic-Assisted Gait Training in chronic stroke patients: Preliminary results of an Italian bi-centre study. NeuroRehabilitation. 2017;41(4):775-782. doi: 10.3233/NRE-172156.
Burnham KP, Anderson DR. Multimodel Inference: Understanding AIC and BIC in Model Selection. Sociological Methods & Research. 2004;33(2):261-304. doi:10.1177/0049124104268644
Castelli L, De Luca F, Marchetti MR, Sellitto G, Fanelli F, Prosperini L. The dual task-cost of standing balance affects quality of life in mildly disabled MS people. Neurol Sci. 2016 May;37(5):673-9. doi: 10.1007/s10072-015-2456-y. Epub 2016 Jan 4.
Cattaneo D, Carpinella I, Aprile I, Prosperini L, Montesano A, Jonsdottir J. Comparison of upright balance in stroke, Parkinson and multiple sclerosis. Acta Neurol Scand. 2016 May;133(5):346-54. doi: 10.1111/ane.12466. Epub 2015 Aug 3.
Davis RB, Õunpuu S, Tyburski D, Gage JR. A gait analysis data collection and reduction technique. Hum. Mov. Sci. 1991; 10, 575-587
Glyn-Jones S, Palmer AJ, Agricola R, Price AJ, Vincent TL, Weinans H, Carr AJ. Osteoarthritis. Lancet. 2015 Jul 25;386(9991):376-87. doi: 10.1016/S0140-6736(14)60802-3. Epub 2015 Mar 4.
Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
Hu LT, Bentler PM. Fit indices in covariance structure modeling: Sensitivity to underparameterized model misspecification. Psychological Methods. 1998, 3(4), 424-453. doi: 10.1037/1082-989X.3.4.424
Hu LT, Bentler PM. Cutoff Criteria for Fit Indexes in Covariance Structure Analysis: Conventional Criteria versus New Alternatives. Structural Equation Modeling, 1999, 6, 1-55. doi: 10.1080/10705519909540118
Julious, SA. 'Sample size of 12 per group rule of thumb for a pilot study'. Pharmaceutical Statistics. 2005, Vol 4. Pages 287-291.
Kline, RB. (2016). Principles and Practice of Structural Equation Modeling, 4th Edn. New York, NY: The Guilford Press.
MacCallum RC, Browne MW, Sugawara HM. Power analysis and determination of sample size for covariance structure modeling. Psychological Methods, 1996, 1(2), 130-149. doi: 10.1037/1082-989X.1.2.130
Muthén, BO and Curran PJ. General longitudinal modeling of individual differences in experimental designs: a latent variable framework for analysis and power estimation. Psychol. Methods 1997, 2, 371-402. doi: 10.1037/1082-989X.2.4.371
Prosperini L, Castelli L, De Luca F, Fabiano F, Ferrante I, De Giglio L. Task-dependent deterioration of balance underpinning cognitive-postural interference in MS. Neurology. 2016 Sep 13;87(11):1085-92. doi: 10.1212/WNL.0000000000003090. Epub 2016 Aug 12.
Prosperini L, Castelli L, Sellitto G, De Luca F, De Giglio L, Gurreri F, Pozzilli C. Investigating the phenomenon of "cognitive-motor interference" in multiple sclerosis by means of dual-task posturography. Gait Posture. 2015 Mar;41(3):780-5. doi: 10.1016/j.gaitpost.2015.02.002. Epub 2015 Feb 21.
Sinusas K. Osteoarthritis: diagnosis and treatment. Am Fam Physician. 2012 Jan 1;85(1):49-56.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0022215/22
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.