RObotic Assisted Rehabilitation for Balance and Gait in Orthopedic Patients: Effects on Functional, Motor, and Cognitive Outcomes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Berg Balance Scale (BBS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 55 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental: Technological Group
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.
干预措施: Technological Rehabilitation (Device)
No Intervention: Control Group
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.).
结局指标
主要结局
Berg Balance Scale (BBS)
时间窗: 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.
次要结局
- 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)
研究者
GIOVANNINI SILVIA
Researcher
Fondazione Policlinico Universitario Agostino Gemelli IRCCS