NCT05459584

Robotic Assisted Rehabilitation for Balance and Gait in Orthopedic Patients.

Completed NA Last updated 24 January 2024

What this trial tests

NA trial testing Technological Rehabilitation in Osteoarthritis, Knee in 24 participants. Completed in 31 October 2023.

Timeline

1 August 2022

Primary endpoint
31 August 2023

31 October 2023

Quick facts

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	24
Start date	1 August 2022
Primary completion	31 August 2023
Estimated completion	31 October 2023
Sites	1 location across Italy

Drugs / interventions tested

• Technological Rehabilitation

Conditions studied

• Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →
• Osteoarthritis, Hip — all drugs for Osteoarthritis, Hip →
• Gait Disorders in Old Age — all drugs for Gait Disorders in Old Age →
• Balance; Distorted — all drugs for Balance; Distorted →

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

Adults 55 to 99, any sex, with Osteoarthritis, Knee or Osteoarthritis, Hip. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.