Clinical trial NCT05459584: Robotic Assisted Rehabilitation for Balance and Gait in Orthopedic Patients.
Official title: RObotic Assisted Rehabilitation for Balance and Gait in Orthopedic Patients: Effects on Functional, Motor, and Cognitive Outcomes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Gait Disorders in Old Age
Balance; Distorted
Keywords: Rehabilitation
Technology
Balance
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional pilot randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: Change from Baseline Ambulation Index at 4 weeks
Secondary outcomes:
measure: Motricity Index (MI)
timeFrame: Change from Baseline Ambulation Index at 4 weeks
measure: Timed Up and Go Test (TUG)
timeFrame: Change from Baseline Ambulation Index at 4 weeks
measure: Knee Injury and Osteoarthritis Outcome Score - Italian Version (KOOS-I)
timeFrame: Change from Baseline Ambulation Index at 4 weeks
measure: Hip disability and Osteoarthritis Outcome Score - Italian version (HOOS-I)
timeFrame: Change from Baseline Ambulation Index at 4 weeks
measure: Ambulation Index (AI)
timeFrame: Change from Baseline Ambulation Index at 4 weeks
measure: Walking handicap scale (WHS)
timeFrame: Change from Baseline Walking handicap scale at 4 weeks
measure: Functional Ambulation Classification (FAC)
timeFrame: Change from Baseline Functional Ambulation Classification at 4 weeks
measure: 10 Meter Walk Test (10mWT)
timeFrame: Change from Baseline 10 Meter Walk Test at 4 weeks
measure: Six-Minute Walk test (6MWT)
timeFrame: Change from Baseline 10 Meter Walk Test at 4 weeks
measure: Modified Barthel Index (mBI)
timeFrame: Change from Baseline 10 Meter Walk Test at 4 weeks
measure: EuroQol- 5 Dimension (EQ-5D)
timeFrame: Change from Baseline 10 Meter Walk Test at 4 weeks
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Change from Baseline 10 Meter Walk Test at 4 weeks
measure: Fatigue Scale for Motor and Cognitive Function (FSMC)
timeFrame: Change from Baseline 10 Meter Walk Test at 4 weeks
measure: Frontal Assessment Battery (FAB)
timeFrame: Change from Baseline 10 Meter Walk Test at 4 weeks
measure: Trial Making Test (TMT)
timeFrame: Change from Baseline 10 Meter Walk Test at 4 weeks
measure: Stroop Colour Word Test (SCWT)
timeFrame: Change from Baseline 10 Meter Walk Test at 4 weeks
measure: Cancellation Test of Digit (CTD)
timeFrame: Change from Baseline 10 Meter Walk Test at 4 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitaria A. Gemelli IRCCS
name: Silvia Giovannini, MD, phD
role: PRINCIPAL_INVESTIGATOR
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