NCT05459584

Robotic Assisted Rehabilitation for Balance and Gait in Orthopedic Patients.

RObotic Assisted Rehabilitation for Balance and Gait in Orthopedic Patients: Effects on Functional, Motor, and Cognitive Outcomes.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 55 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Technological Rehabilitation	Specific rehabilitation for balance disorder using the robotic platform

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-08-31
• Completion: 2023-10-31
• First posted: 2022-07-15
• Last updated: 2024-01-24

Locations

1 site across 1 country: Italy