Robotic Assisted Rehabilitation for Balance and Gait in Orthopedic Patients.

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

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

Treatments: Device: Technological Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05459584

0022215/22

Details and patient eligibility

About

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.

Full description

Twenty-four patients of both sexes will be recruited, evaluated, and treated at Rehabilitation and Physical Medicine Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS of Rome, from August 2022 to August 2023. Patients will be divided into two groups by 1:1 randomization ratio: one group (Technological Group, TG) will perform specific rehabilitation for the balance using the robotic platform (Hunova®, Movendo Technology srl, Genova, IT) 3 times a week, for 4 weeks (12 total sessions), for 45 minutes of treatment, in addition to the conventional treatment and one group will perform only the conventional treatment (Control Group, CG), as per daily routine.

Enrollment: 24 patients

Sex: All

Ages: 55 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Experimental: Technological Group

Experimental group

Description:

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.

Treatment:

Device: Technological Rehabilitation

No Intervention: Control Group

No Intervention group

Description:

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.).