RObotic Assisted Rehabilitation for Balance and Gait in Orthopedic Patients: Effects on Functional, Motor, and Cognitive Outcomes.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Berg Balance Scale (BBS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 55 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Berg Balance Scale (BBS)
Time Frame: Change from Baseline Ambulation Index at 4 weeks
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.
Secondary Outcomes
- 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)
- Functional Ambulation Classification (FAC)(Change from Baseline Functional Ambulation Classification at 4 weeks)
- 10 Meter Walk Test (10mWT)(Change from Baseline 10 Meter Walk Test at 4 weeks)
- Walking handicap scale (WHS)(Change from Baseline Walking handicap scale at 4 weeks)
- Modified Barthel Index (mBI)(Change from Baseline 10 Meter Walk Test at 4 weeks)
- Modified Fatigue Impact Scale (MFIS)(Change from Baseline 10 Meter Walk Test at 4 weeks)
- 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)
- EuroQol- 5 Dimension (EQ-5D)(Change from Baseline 10 Meter Walk Test at 4 weeks)
- Frontal Assessment Battery (FAB)(Change from Baseline 10 Meter Walk Test at 4 weeks)
- Ambulation Index (AI)(Change from Baseline Ambulation Index at 4 weeks)
- Six-Minute Walk test (6MWT)(Change from Baseline 10 Meter Walk Test at 4 weeks)
- Fatigue Scale for Motor and Cognitive Function (FSMC)(Change from Baseline 10 Meter Walk Test at 4 weeks)
- Trial Making Test (TMT)(Change from Baseline 10 Meter Walk Test at 4 weeks)
- Stroop Colour Word Test (SCWT)(Change from Baseline 10 Meter Walk Test at 4 weeks)
- Cancellation Test of Digit (CTD)(Change from Baseline 10 Meter Walk Test at 4 weeks)
Investigators
GIOVANNINI SILVIA
Researcher
Fondazione Policlinico Universitario Agostino Gemelli IRCCS