|A study of paraplegic orthoses gait training and innovation of orthotic design for spinal cord injured patients with paraplegia
|Zhang, Ming (BME)
Leung, K. L. Aaron (BME)
|Paraplegics -- Rehabilitation
Hong Kong Polytechnic University -- Dissertations
|Department of Biomedical Engineering
|xii, 193 pages : color illustrations
|Spinal cord injury (SCI) induces paralysis of the lower extremities due to the break of connection between the central nervous system and the muscular units of the lower body. Patients with paraplegia usually become very sedentary. Furthermore, the intensity of activities of daily living is not strenuous enough to maintain or elicit improvements in either cardiorespiratory fitness or muscular strength, which could lead to many secondary diseases. The upright ambulation with orthoses can benefit people with lower-limb paralysis. Consequently, the ability to stand and walk using orthoses is an important goal for patients with paraplegia. However, some adverse events could be caused by inappropriate training. The appropriate orthotic training protocol for paraplegic patients remains unclear. Mechanical limitation of Reciprocating Gait Orthoses (RGOs) with stiff knee joints caused high energy consumption for paraplegic patients. Based on the above issues, this research aims to provide evidence the effectiveness of orthotic training protocol and the feasibility of development design. Therefore, a further clinical trial, a development design, and a gait analysis were conducted as follows. This study includes three main parts: (1) To conduct a randomized controlled trial (RCT) and evaluate the effectiveness of quantitative intensity orthotic training on patients with paraplegia. (2) To develop a new stance control knee joint combined with reciprocating gait orthoses. (3) To conduct a gait experiment to assess the feasibility of the new stance control RGOs. The first part: A total of 26 patients finished the RCT including 9 subjects (Age: 38.67±11.00year, 7Male/2Female, Weight: 64.56±11.04Kg, Height: 169.89±8.70m; Lesion lever: 9T) of the control group (CG), 8 subjects (Age: 38.63±8.85year, 5Male/3Female, Weight: 61.75±9.91Kg, Height: 171.25±8.07m; Lesion lever: 8T) of the light-intensity group (LG), and 9 subjects (Age: 36.22±7.68year, 5Male/4Female, Weight: 59.89±15.20Kg, Height: 165.44±5.98m; Lesion lever: 8T/1L) of the moderate intensity group (MG). All patients underwent a 1 session/day, 5 sessions per week orthotic training program using RGOs, the exercise time per session was increased for five minutes every two weeks for a total of eight weeks. The gait efficiency (Physiological Cost Index, PCI), cardiorespiratory fitness (Rating of Perceived Exertion, RPE; 6 Minute Walk Test, 6MWT), and functional ambulation ability (10 Meter Walk Test, 10MWT; Timed Up & Go test, TUG; Walking Index for Spinal Cord Injury II, WISCI II) of patients were measured at baseline, four weeks and eight weeks; The quality of life (World Health Organization Quality of Life BREF, WHOQOL-BREF) and activity of daily living (Modified Barthel Index, MBI) were assessed at baseline, eight weeks and three months. Two-way repeated measures analysis of variance (Two-way Repeated ANOVA) was used to analyze the data of each group at the baseline, mid-point, and end-point. The results showed that patients with quantitative intensity orthotic training could significantly promote energy efficiency (MG, P=0.015; LG, P=0.044), cardiorespiratory fitness (LG, P=0.003; MG, P=0.001), ambulation ability (10MWT: LG, P<0.001,MG, P=0.011; TUG: LG, P=0.008, MG, P=0.001) and ADL (LG, p'<0.001; MG, p'<0.001); The QoL (CG, p'=0.031) and ambulation ability (CG, p'=0.003) could significantly decline without regular orthotic training. Patients with moderate intensity orthotic training have better gait efficiency (p'=0.017). The conclusion of this part is quantitative intensity orthotic training regularly could benefit paraplegic patients.
The second part: A new purely mechanical stance control knee joint triggered by hip was designed, including the hip trigger module and ratchet and pawl module. The model of newly design knee joint was 3D printed. The rotating hip joint can pull the cable with the reciprocating mechanism. The ratchet and pawl can achieve the lock and free knee joint with the aid of cable and springs. The summary of this part is this newly developed knee joint was designed. This design combines stance control mechanics and reciprocating mechanics. The third part: A gait analysis experiment was conducted to assess the effectiveness of paraplegic patients with the new stance control RGOs. The included healthy subjects (n=6) completed normal gait (NG), stiff knee RGOs gait (SKG), and stance control RGOs gait (SCG) test by the before-and-after clinical study, set a one-day washout period. A 3D KNEE ANALYSER (KneeKG™, EMOVI INC. Canada) was used to capture the kinematic parameters of participants. These parameters of the range of knee flexion and extension, the degree of knee joint at heel strike, the degree of knee joint at foot flat, and the range of knee movement in stance phase were assessed for three groups. One-way ANOVA was used to analyze the differences in the above gait parameters of the subjects before and after the intervention. The range of knee flexion and extension in the swing phase of the SCG was significantly greater than that in the SKG (P<0.001); There was no difference of the range of knee motion in the stance phase between the SKG and SCG. The conclusion of this part is the newly knee joint for purely mechanical stance control combined with the reciprocating gait orthoses could provide motion in the swing phase compared with the traditional RGOs for healthy participants. The overall conclusion is that the quantitative intensity orthotic training regularly could benefit the paraplegic patients, and the developed orthoses could improve the performance of the gait of users, compared with the traditional RGOs.
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