Robotic Assisted Rehabilitation for Balance and Gait in Orthopedic Patients.

NCT05459584 | Completed

• 1 other identifier: 0022215/22
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis is a chronic, degenerative disease affecting the joints. It is characterized by the presence of bone tissue that goes to make up for the loss of articular cartilage, causing pain and limitation of movement. Osteoarthritis is a direct consequence of aging: it affects almost all 70-year-olds, peaking between 75 and 79 years. The presence of osteoarthritic processes at the hip and knee joints can result in pain, difficulty maintaining standing for a long time, and difficulty walking with loss of balance, increasing the risk of accidental falls to the ground. Falls are a frequent cause of mortality and morbidity and, often, limit autonomy leading to premature entry into assisted living facilities. 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.

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Gait Disorders in Old Age; Balance; Distorted

Keywords

Rehabilitation; Technology; Balance

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale (BBS)

  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.

  Change from Baseline Ambulation Index at 4 weeks

Secondary Outcomes (17)

• Motricity Index (MI)

  Change from Baseline Ambulation Index at 4 weeks

• Timed Up and Go Test (TUG)

  Change from Baseline Ambulation Index at 4 weeks

• Knee Injury and Osteoarthritis Outcome Score - Italian Version (KOOS-I)

  Change from Baseline Ambulation Index at 4 weeks

• Hip disability and Osteoarthritis Outcome Score - Italian version (HOOS-I)

  Change from Baseline Ambulation Index at 4 weeks

• Ambulation Index (AI)

  Change from Baseline Ambulation Index at 4 weeks

Study Arms (2)

Experimental: Technological Group

EXPERIMENTAL

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.

Device: Technological Rehabilitation

No Intervention: Control Group

NO INTERVENTION

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.).

Interventions

Technological Rehabilitation DEVICE

Specific rehabilitation for balance disorder using the robotic platform

Also known as: Hunova® Movendo Technology srl

Experimental: Technological Group

Eligibility Criteria

• Age: 55 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 55 years;
• 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.

You may not qualify if:

• Presence of systemic, neurological, cardiac pathologies that make walking hazardous or cause motor deficits;
• Presence of oncological pathologies;
• Presence of plantar ulcers;
• Partial or total amputation of foot segments.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

Location

Related Publications (19)

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  BACKGROUND

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  PMID: 25748615 RESULT

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  RESULT

• 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.

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• 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.

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MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Silvia Giovannini, MD, phD

  Fondazione Policlinico Universitaria A. Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: Interventional pilot randomized controlled trial

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 15, 2022
• Study Start: August 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: October 31, 2023
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)