Clinical Study of the Effects of a Robotic Walker and Immersive Technology for Hip Fracture Rehabilitation in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Effects of robotic system (SWalker + VR) use in gait rehabilitation - Autonomy/independence. Mobility
研究概览
简要总结
This project is structured in two distinct phases. The first phase deals with the recovery of the hip fracture in the acute phase up to ambulation, and the second is understood as the continuation of functional improvement of gait. In the first phase, the aim is to evaluate the effects of the use of the robotic device (SWalker) on the physical improvement of the patient. While in the second phase, the objective is to evaluate the effects of virtual reality technology combined with the use of the SWalker.Therefore, the following specific objectives are identified:
- Phase I: To analyze the effects of SWalker application in patients with acute hip fracture on clinical parameters of rehabilitation.
- Phase II: To study the effects of the application of the SWalker combined with immersive technology in people with impaired gait function after hip fracture.
详细描述
In the preliminary phase, the usability and acceptance of the SWalker II system combined with virtual reality is evaluated with a group of healthy subjects. For this purpose, an exposure session and the evaluation of the system based on questionnaires are carried out. On the other hand, a gait characterization session (capture of ROM and EMG) is performed inside and outside the walker with different speeds and weight loads.
In the first phase of the clinical study, patients with hip fractures in the early rehabilitation phase were recruited. They are randomly assigned to a control group or experiment group. And for a period of 6 weeks, both groups carry out the same rehabilitation exercise program based on strength, balance and ambulation exercise. The difference is that the experimental group performs the rehabilitation exercises with the SWalker, and the control group performs these exercises with conventional parallel bars.
In the second phase of the clinical study, these same patients who have passed the first pass, move on to a 6-weeks program of maintenance and improvement of gait function. Again, they are divided into 2 groups, control and experimental. So the control group will perform walking exercises with the Swalker and conventional balance exercises and the experimental group will perform walking and balance exercises with SWalker and virtual reality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants of both sexes over 65 years of age,
- •Patients with a height of less than 180 cm,
- •Patients weighing less than 90 kg,
- •Patients who have suffered a hip fracture* and wish to participate in the study.
- •In addition, they must sign and understand the informed consent form.
排除标准
- •Cognitive status insufficient to understand and execute instructions given by the physiotherapist.
- •Patients needing rehabilitation after hip fracture may vary from a few days to a few weeks after the period of occurrence of the hip fracture, depending on the complications that could arise and the type of surgery used, with a pre-set limit of one month.
研究组 & 干预措施
Preliminary Phase
20 healthy subjects will perform an experimental session for characterization of functional status with clinical scales; characterization of gait with SWalker using ROM and EMG at different speeds and weight bearing; and assessment of system usability with VR using standardized questionnaires.
干预措施: Preliminary Phase (Other)
Phase I and II
In both phases 100 subjects will perform a gait rehabilitation intervention program (phase 1) and maintenance (phase 2), in which they will employ the use of the robotic walker and virtual reality depending on the group and phase. The evolution of functional clinical parameters will be studied for both groups and phases.
干预措施: Phase I - Early gait rehabilitation (Other)
Phase I and II
In both phases 100 subjects will perform a gait rehabilitation intervention program (phase 1) and maintenance (phase 2), in which they will employ the use of the robotic walker and virtual reality depending on the group and phase. The evolution of functional clinical parameters will be studied for both groups and phases.
干预措施: Phase II - Maintenance gait function ( with VR) (Other)
结局指标
主要结局
Effects of robotic system (SWalker + VR) use in gait rehabilitation - Autonomy/independence. Mobility
时间窗: 6 weeks
The evolution of the functional clinical scales will be studied (autonomy/independence): Mobility using the New Mobility Test (Physical test), also known as Parker Mobility Test. It is a composite score of the patient's ability to perform: indoor walking, outdoor walking, and shopping, providing a score between 0 and 3 (0 - not at all, 1 - with help from another person, 2 - with an aid, 3 - no difficulty) for each function, resulting in a total score from 0 (no walking ability at all) to 9 (fully independent) .
Effects of robotic system (SWalker + VR) use in gait rehabilitation - Pain
时间窗: 6 weeks
The evolution of the functional clinical scales will be studied (pain): Pain by means of the Verbal Rating Scale, a five-point scale and consists of a list of adjectives describing various levels of symptom intensity (0= no itch, 1= mild itch, 2= moderate itch , 3= severe itch and 4=very severe itch).
Effects of robotic system (SWalker + VR) use in gait rehabilitation - Gait
时间窗: 6 weeks
The evolution of the functional clinical scales will be studied (gait and balance): Gait speed using the 10 metre Walk Test (10MWT) (physical test), provided the patient can walk without human assistance; The 10 Metre Walk Test is a performance measure used to assess walking speed in meters per second over a short distance. The total time is recorded in m/s. Household Ambulator \<0.40 m/s; Limited Community Ambulator 0.40 to \<0.80 m/s; Community Ambulator ≥0.80 m/s.
Effects of robotic system (SWalker + VR) use in gait rehabilitation - Autonomy/independence. Ambulation
时间窗: 6 weeks
The evolution of the functional clinical scales will be studied (autonomy/independence): Functional limitation in early post-acute phase by means of Cumulative Ambulation Score (CAS) (Physical test). The CAS describes the patient's independence with regard to three activities (getting in and out of bed, sit-to-stand-to-sit from a chair, and walking). Each activity is assessed on a three-point ordinal scale from 0-2 (0 = Not able to, despite human assistance and verbal cueing, 1 = Able to, with human assistance and/or verbal cueing from one or more persons, 2 = Able to safely, without human assistance or verbal cueing, use of a walking aid allowed) resulting in a total daily CAS score ranging from 0 to 6.
Effects of robotic system (SWalker + VR) use in gait rehabilitation - Gait and Balance
时间窗: 6 weeks
The evolution of the functional clinical scales will be studied (gait and balance): Functionality through the Timed Up \& Go test (physical test). Its score is the time spent (seconds) while the subject is standing from an armchair, walking 3 meters, returning to the chair walking 3 additional meters and sitting down. It is considered that scores of 10 seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance.
Effects of robotic system (SWalker + VR) use in gait rehabilitation - Strength
时间窗: 6 weeks
The evolution of the functional clinical scales will be studied (strength): Muscle strength of the lower limbs through quadriceps extension test or lower limb dynamometer (physiological parameter).
Effects of robotic system (SWalker + VR) use in gait rehabilitation - Autonomy/independence. Fear of falling
时间窗: 6 weeks
The evolution of the functional clinical scales will be studied (autonomy/independence): Fear of falling by means of the Falls Efficacy Scale International (questionnaire); The total score ranges from 16 to 64, where 16 indicates "no concern" and 64 indicates "extremely concerned about falling" during the performance of the specific activities suggested by the questionnaire.
Effects of robotic system (SWalker + VR) use in gait rehabilitation - Autonomy/independence. Quality of life.
时间窗: 6 weeks
The evolution of the functional clinical scales will be studied (autonomy/independence): Quality of life through the 36-Item Short Form Survey (SF-36) (questionnaire). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
次要结局
- Feasibility of robotic system (SWalker) - Gait(1 week)
- Usability of virtual reality system combined with the robotic system (SWalker) - Safety(1 week)
- Usability of virtual reality system combined with the robotic system (SWalker) - Usability(1 week)
- Usability of virtual reality system combined with the robotic system (SWalker) - Presence(1 week)
- Feasibility of robotic system (SWalker) - Hip ROM(1 week)
- Feasibility of robotic system (SWalker) - EMG activity(1 week)
- Feasibility of robotic system (SWalker) - Physical Performance(1 week)
- Feasibility of robotic system (SWalker) - Gait and Balance(1 week)