Optimum Duration for Efficient Gait Training in New Transtibial Prosthesis Users

Introduction

Physical loss of a body part can result in significant changes in body structure and function, loss of self-confidence, hindering social and daily activities. One of the major needs of a person who has undergone an amputation is to regain the ability to walk, independently. To achieve this, the individual is given a prosthesis to compensate for the loss of body structure and function. Training a patient to walk again can be a challenge.¹ To overcome this, gait training is the key to ambulation and the main focus is to improve the symmetry, gait velocity, cadence, and step length of a person with an amputation.² The aim of the rehabilitation is to aid the amputee gain independence at the highest level they can, with the most efficient gait possible.³ Prosthetic gait training has several goals: to help amputees adapt to their new condition, to achieve optimal weight bearing on the prosthesis, to improve balance and reaction to disturbance, to restore optimal gait pattern, to reduce the amount of energy needed to walk and to teach amputees how to perform daily operations like sitting down and walking up and down the stairs. All this will help amputees regain their self-confidence and play an active role in society.

A number of studies investigated different gait training methods in the form of over ground, treadmill and anti-gravity with different durations for sessions. The over ground gait training had various methods like task-oriented, agility, error augmentation, virtual based real feedback, anti-gravity, and home-based training. The different methods of gait training are applied to the patient with different durations.⁴ There are no studies regarding the efficient/optimum duration of gait training. As we are going through the process of urbanization, our life is getting busier. Managing time is of utmost importance to be able to conduct projects effectively, and spend more of their rehabilitation time practicing walking compared to all other activities. This helps to make the schedule and allot timings for the patients and also to the prosthetist and orthotist or physiotherapist for gait training. This study was conducted to determine the optimum duration of gait training for the new transtibial user with regard to stability, balance, speed, and mobility.

Materials and Methods

This was an experimental study conducted from April to July 2022. The criteria to include participants were, a unilateral transtibial amputee, an adult (25 to 70 years), being able to follow verbal instructions, free from knee flexion contracture in the residual limb, a new transtibial prosthetic user, well-healed residual limb to tolerate the prosthesis initially for at least 15 minutes. Exclusion criteria included bilateral transtibial amputee, age <25 and >70 years, difficulty in understanding instructions, residual limb with knee flexion contracture, old trans tibial prosthetic user, patients with amputation of any other limb limiting prosthetic training and limiting the prosthetic use initially for at least 15 minutes. This study protocol was reviewed and approved by the the institutional ethical review board of Mobility India and informed written consent was obtained from all the subjects prior to enrollment in the study. The participants were from different rehabilitation centers, hospitals, private clinics and non-governmental organizations.

Participants were allocated to two groups by the researcher on the basis of the patient’s prosthesis, socket, and foot. Both the groups received conventional gait training (ICRC) protocol. The participants in Group 1 had 20 mins of active gait training and those in Group 2 had 40 mins of active gait training durations. Both groups had 20 or 40 mins of active gait training for one week (20 or 40 mins × 7 days). Here active gait training meant the time calculated or noted by the stopwatch without considering the rest taken by the patients. The outcome measure was taken for every patient after completing seven days of gait training. The active duration of each session of the patients was noted by using a stopwatch, where the resting timings were not considered in the gait training duration of each session. It was applied to both group 1 and group 2.

After completing seven days of gait training and exercise, an outcome data form was administered to each patient. The data collection was done by the researcher for each patient in the P and O settings where the prosthesis was given for that patient. The participants did every outcome measure test one after the other. Researcher explained the outcome measure test to the participants before they performed it. Each outcome measure test had three trials except Berg Balance Scale (BBS).

To evaluate the effects of two different gait training durations, the following scales and tests were used.

Berg Balance Scale: The Berg Balance Scale (BBS) is a 14-item scale designed to evaluate balance. Scores vary between 0 and 56 points, with higher scores reflecting a greater ability to balance. It is a validated test, and the minimum detectable changes in elderly populations have been described.

Four Square Step Test: The Four-Square Step Test (FSST) is a test that assesses the risk of falling among amputees. It records the time (in seconds) that the patient takes to step into four squares that are formed by two crutches, starting in clockwise direction and then stepping back in counter-clockwise direction. In transtibial amputees, a time of 24 s or more is considered a predictive value of falling. The FSST has high consistency, sensitivity, and specificity and has shown excellent inter-observer and test-retest reliabilities.

10-Meter Walk Test: The 10-meter walk test (10MWT) is a performance-based measure that may be used to assess gait speed in patients with one or more lowerlimb amputations who may or may not be using a prosthesis. 10 Meter Walk Test (10MWT) performed at self-selected and fast gait speeds provides insight regarding typical walking speed and patient capacity for negotiating community environments, e.g., crosswalks. Two meters for acceleration and deceleration is provided at either course end with the goal of steady-state walking during the timed 10 central meters.

L test: The L test is a modified version of the Timed Up and Go (TUG). The L test incorporates two transfers and four turns, of which at least one would be to the opposite side. The total distance covered is a 20-meter walk. The time (in seconds, to the nearest 10th of a second) that it took for the subject to stand from an armless chair, walk 10 m (in the shape of an L) at the subject's usual walking speed, turn 180 degrees, and return 10 m (in the shape of an L) to a seated position was recorded.⁵

Results

The number of participants was 16, with 75% males and 25% females. The average age was 52 years (SD = 8.68). The common etiology of amputation noted were trauma and diabetes (Figure 1). 

A total of eight patients were assigned to group 1 (20 mins) and eight patients were assigned to group 2 (Figure 2). The results of the overall evaluation of the 16 patients are as follows.

Evaluation of balance

On the BBS, patients in group 1 obtained an average score of 48.50±2.83 (SD=3.46), and a score of 53.50 ± 3.33 (SD=0.92) was noted in group 2 (Table 1). The difference was statistically significant between both group 1 and group 2 patients (P <0.05).

To complete the FSST, patients took an average of 11.75±2.23 s (SD=2.29) in group 1 and 9.03±1.28 s (SD=1.28) in group 2 (Table 2).

To complete the L test, patients took an average of 27.61 min (SD=2.82) in group 1 and 22.24 min (SD=3.32) in group 2 (Table 3).

To complete the 10MWT (Meter Walking test), patients took an average of 8.92 ± 2.3s (SD=2.99) in group 1 and 5.78 ± 0.35s (SD=0.34) in group 2. Overall, the patients took an average of 7.35 s (SD=2.62) to complete the 10MWT (Table 4).

The results for group 1 and group 2 patients are given in Table 5. It is worth drawing attention to the fact that the group 2 (40 mins) gait training participants were the ones who experienced a statistically significant improvement in all measures of balance, stability, mobility and speed. Those parameter showed statistically significant difference between group 1 and group 2 patients (P <0.05).

Discussion

The aim of the study was to investigate the impact of gait training duration in new transtibial users using the conventional gait training methods.

Jason Highsmith et al., published a systematic literature review with evidence supporting gait training interventions to formulate evidence to guide practice. It covered two areas of gait training interventions: 1) over ground and 2) treadmill training. It stated that over ground gait training with other auditory, manual, and physiological awareness interventions are effective in improving gait.⁴

Few authors conducted studies pertaining to efficacy and safety of anti-gravity treadmill training for prosthetic rehabilitation following below-knee amputation. Hadeya Anjum et al., conducted a study to determine the effects of Proprioceptive neuromuscular facilitation (PNF) and compared with the traditional prosthetic strength training,³ Paul W Kline et al., conducted a study to evaluate the treadmill-based, error-augmentation gait training protocol for improving gait symmetry in patients with non-traumatic transtibial amputation. Darter et al., reported a VR-based gait training program that provides real-time feedback for improving biomechanical and physiological performance.⁶

The above studies were conducted in developed countries where they used the instruments as an intervention. However in India, approximately 30% of the population lives in urban areas, whereas 70% live in rural areas.⁷

The ICRC gait training protocol is the most commonly used gait training method in low-income and middleincome countries. Thus in the current research, ICRC gait training was included as the gait training protocol. In order to retrain gait and improve balance, studies have investigated different methods of gait rehabilitation in individuals with altered gait patterns. However, there are no studies regarding the gait training duration.

In our study, patients in group 1 were seen to complete the L test by group 1 in 27.6175±2.83 min and group 2 in 22.2425±3.33 min, which was statistically significant (P=0.011). In a study conducted by Deathe AB and Miller in 2001 to check validity and reliability, the results show the mean value of the L test was 32.26 min in time 1 and time 2 was 29.7 min.⁸ The L test means for times 1, 2, and 3 were not different. The researcher included even the TUG test for mobility and in the beginning, two patients had difficulty as it took long time for completing all the tests.⁸ Hence the researcher removed the TUG test and conducted only L test in the mobility domain. The 20-m distance covered by the L test is twice that of the 10-Meter Walk Test, and three times that of the TUG. The distance was increased with the intent that the L Test would be more responsive than the other tests, and therefore, more useful when used in younger individuals with a lower-limb amputation. Although we cannot comment specifically on the true nature of responsiveness of the L Test, we observed that it does minimize the ceiling effect observed in the TUG.⁸

In the FSST (Four Square Step Test) for stability, the patients in group 1 took a short time of 8.92s and those in group 2 took 8.14. Jaclyn et al., conducted a study to summarize outcome measurement research among adults with lower limb loss showing a score of 10.54±5.3 in patients aged 55±21 years, where the scores obtained by the patients ranged between the same score. In initial trial 1, the patients found it difficult to complete the tasks included. The trial 2 proceeded well, while in trial 3, they could complete the required tests without any error. The least score of the patients was considered the best for every individual.

In 10MWT (Meter Walking Test) which was for speed, the patients in group 1 took a time of 6.87 s and a mean time of 8.92 s, while the patients in group 2 took a short time of 5.46 s and mean time of 5.78 s. Jaclyn et al. conducted a study to summarize outcome measurement research among adults with lower limb loss showing a score of K4 aged 46±12 as 1.21±0.005 (m/s) and aged 60±12 as 0.88 ± 0.004 (m/s) in self-selected speed. The scores obtained by the patients in group 1 and group 2 were noted to be in the same score range.⁵

Prosthesis plays the most important role; it substitutes for the removed or amputated limb. There were two types of prosthesis, Modular (Endoskeleton) and Exoskeleton. Sahoo conducted a comparative study on laminated exoskeletal and modular endoskeletal transtibial prosthesis. It concluded that modular endoskeletal prosthesis was superior to the exoskeletal transtibial prosthesis. In the present study, every participant was using modular endoskeletal prosthesis.⁹

Limitations

The sample size was small. The duration was also less where the availability of the patients was less. Five centres were utilized in this study with different therapists and prosthetists for gait training. Initial stage patients felt pain as they were new users. Hence their resting time was comparatively longer.

Conclusion

The results of this study point at the significant impact of gait training on stability, mobility, balance and speed. As per this study, we can conclude that 40 minutes of gait training duration was effective compared to 20 minutes gait training. Therefore, this finding suggests that longer duration of gait training may provide efficient results for prosthetic gait training.

Conflict of interest

None