Gait Training Combined With Strategies to Induce Transference to Real Life for People With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Berg Balance Scale - Balance Assessment
研究概览
简要总结
A variety of rehabilitation techniques focused on improving disability after stroke have shown significant changes on walking speed, and endurance. Also, the administration of combined techniques showed better results. Previous studies have suggested that embedding behavioral strategies in neurorehabilitation protocols can enhance patient's adherence and participation outside the clinical setting. The addition of a group of behavioral strategies called Transfer Package (TP) has been widely used in motor training protocol (e.g. Constraint-Induced Movement Therapy). The TP has shown to enhance the effects of treatment 2.4 times when compared to motor training alone. However, the effect of TP when combined with robotic gait training remains unexplored. In this study our goal is to combine the TP with robotic gait training. The hypothesis is that using the TP in combination with robotic gait training will enhance the outcome of robotic gait training alone and will induce long term transference and retention of the motor skills observed after treatment. More importantly, this experimental intervention is more meaningful to the patient and can be more easily implemented on the clinical setting. The aims of this study are (1) to assess transfer and long-term retention of walking and balance skills after robotic treadmill gait training combined with the TP, (2) to understand participants' acceptability and perceptions of the TP as a tool to enhance transfer of skills to real-world situations, and (3) to examine the feasibility of these combined intervention to improve walking and balance after stroke.
详细描述
This proposal seeks to investigate the effect of gait training combined with behavioral strategies on long-term retention of improvements on gait parameters and use of the affected lower-extremity in real-world situations.
Aim 1: To assess transfer and long-term retention of walking and balance skills after robotic treadmill gait training combined with the TP. A total of 24 participants with chronic stoke will be randomly allocated to either treadmill training combined with the TP (TT+TP) or usual TT with an educational approach. The 8-week intervention will consist of three weekly sessions of 1 hour of TT. The experimental group will also receive the TP for 30 minutes and the control group will receive a manual with exercises to be performed at home. The primary outcome is the change in Lower-Extremity Motor Activity Log. Also, change in walking speed, endurance, functional strength and use of the affected LE will be assessed at 3- and 6-months after the intervention.
Aim 2: To understand participants' acceptability and perceptions of the TP as a tool to enhance transfer of skills to real-world situations. A qualitative approach will be used for evaluating the acceptability of the TT + TP protocol. Individual interviews will be conducted with all participants to assess their opinion about TP, particularly, their perceived influence of the TP on real-life situations.
Aim 3: To examine the feasibility of body weight support treadmill training combined with behavioral strategies to improve walking and balance after stroke. Compliance with the intervention will be measured as the number of sessions attended and number of activities performed outside the clinical setting. Also, the relationship between the outcome changes after the intervention and the participants' perceptions will be explored.
The hypothesis is that the use of the TP will promote long-term retention of the positive changes in walking and balance and also changes in real-world situations. This pilot study will lead to future studies with larger samples in order to compare the effect of body weight support treadmill training combined with the TP. The long-term goal is to provide a systematic combination of strategies to improve gait and mobility after stroke that can be implemented in the clinical setting.
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 (Outcomes Assessor)
盲法说明
Outcomes assessor will not be involved nor present during the training sessions. Also the outcome assessments will be performed without the presence of the interventionist.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older;
- •at least 6 months post stroke;
- •present lower extremity motor impairment secondary to stroke;
- •able to walk at least 10 feet with or without personal assistance;
- •discharged from rehabilitation.
排除标准
- •presence of uncontrolled clinical conditions;
- •weight > 400lb because this is limit supported by the KineAssist
- •other neurologic conditions;
- •Mini-Mental State Examination score (MMSE) <24;
- •inability to provide the informed consent;
- •insufficient language skills to answer the screening, assessments and interview questions.
结局指标
主要结局
Berg Balance Scale - Balance Assessment
时间窗: Pre-treatment (baseline), post-treatment (immediately after the last training session, at the end of week 6 of intervention), 3 months follow up post-intervention, and 6 months follow up post-intervention.
It is a valid and reliable tool to assess balance control in both static and dynamic activities with people with different health conditions. The Berg includes 14 balance tasks, each one scored from 0 (inability to perform or need for maximum assistance) to 4 (able to perform the task without difficulty or independently). The total score range from 0-56 and a score lower than 44 represents high risk of falling.
Lower Extremity Motor Activity Log - Real World Use of the Affected Lower Extremity in Daily Activities.
时间窗: Pre-treatment (baseline), post-treatment (immediately after the last training session, at the end of week 6 of intervention), 3 months follow up post-intervention, and 6 months follow up post-intervention.
It is a semi-structured interview that consists of questions asking the participant the level of assistance, how well her/his performance is, and level of confidence while executing 14 different daily tasks (e.g. walking indoors, climbing stairs) in real world environment. The LE-MAL investigates the transference of the skills addressed during the treatment to different contexts. The LE-MAL is a reliable tool in both test-retest results (r=0.93) and internal consistency (Cronbach's alpha = 0.96). The score range from 0-10, where 0 is a higher level of assistance, worse quality and movement and less confidence, and 10 is given when no assistance is needed, good quality of movement is reported and the person feels completely confident in performing the activity without falling.
10 Meters Walk Test - Walking Speed Assessment
时间窗: Pre-treatment (baseline), post-treatment (immediately after the last training session, at the end of week 6 of intervention), 3 months follow up post-intervention, and 6 months follow up post-intervention.
It is a gait speed measurement, which is an easy and reliable assessment of locomotion. In this assessment, the individual is asked to walk 10 meter, with or without an assistive decide, and the speed is calculated according to the time the individual takes from the beginning to the end of the 10 meter trail. During the self-selected speed, the individual is asked to walk at his/her/their normal speed, as if the person is walking at home. On the fast speed, the individual is asked to speed up and walk fast as he/she/they can, but not running.
次要结局
- Fear of Falling Avoidance Questionnaire - Avoidance Behavior Assessment(Pre-treatment (baseline), post-treatment (immediately after the last training session, at the end of week 6 of intervention), 3 months follow up post-intervention, and 6 months follow up post-intervention.)
- 5-times-sit-to-stand - Functional Strength Assessment(Pre-treatment (baseline), post-treatment (immediately after the last training session, at the end of week 6 of intervention), 3 months follow up post-intervention, and 6 months follow up post-intervention.)
- 6-minutes Walking Test - Energy Expenditure Assessment.(Pre-treatment (baseline), post-treatment (immediately after the last training session, at the end of week 6 of intervention), 3 months follow up post-intervention, and 6 months follow up post-intervention.)
研究者
Sarah dos Anjos
Assistant Professor
University of Alabama at Birmingham