Toward Restoration of Normative Postural Control and Stability Using Neural Control of Powered Prosthetic Ankles
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- aCOM, anticipatory Center of Mass Excursion when the expected disturbance is introduced
研究概览
简要总结
The objective of this proposal is to investigate the effects of training to use direct electromyographic (dEMG) control of a powered prosthetic ankle on transtibial amputees'.
The aimed questions to answer:
- whether dEMG control will improve balance and postural stability of amputees,
- whether dEMG control will lead to more natural neuromuscular control and coordination, 3) whether dEMG control will reduce cognitive processes.
Participants will go through PT guided training on using dEMG controlled prosthetic ankles and are evaluated for their capability on functional tasks.
The results will be compared with a comparison group, which goes through the same training but with their everyday passive prostheses on balance capability, neuromuscular coordination, and cognitive load during locomotion.
详细描述
Lab Visit Experience for Participants with lower limb amputation:
- Number of Lab Visits: 15 visits. Clinicians may recommend skipping some of the visits or tasks based on clinical evaluation and status of the participants.
- Length of Lab Visit: three hours maximum
- First visit: the purpose of the first visit is to conduct consent and conduct measurements to decide walking speed and ABC (amputee balance confidence) score.
- Second visit: this visit is to ensure that the amputees' own socket system can be integrated into the powered prosthetic leg and validate the effectiveness of the EMG interface.
- Third and fourth visits: baseline evaluation with powered prosthesis and passive prosthesis. Each participant will finish the two visits. One of the visits is dedicated to their own passive prosthesis and the other visit is for the powered prosthesis. The sequence of the evaluation is randomized. The tasks conducted in the two visits are generally identical. The only difference is that one of the visits uses the participants' everyday prosthetic foot and the other uses the powered prosthetic ankle
- Fifth and sixth visits: these visits are dedicated to have the participants trained to regain muscle coordination, which is critical to use the powered prosthetic ankle. All the participants will go through these trainings. Based on whether the participants are selected as the powered prosthetic group (Group A) or the passive group (Group B), the participants will finish this training with the powered prosthetic leg or a passive prosthetic leg.
- Seven - eleventh visits: These visits are designed to give participants needed training, so participants are able to integrate the action of the powered prosthetic ankle with their full body motion for various tasks. To ensure that contribution of the training procedure to the performance changes are considered, all the participants will go through the training with the prostheses aligned with their group.
- Twelfth-thirteenth visit (duplicate of Third and fourth visit). These visits are used to evaluate the impact of the training program on the performance of the participants to conduct tasks which are not included in the training procedure. Each participant will conduct the task with both passive and powered prosthetic legs on different days.
- Fourteenth-fifteenth visits (duplicate of Third and fourth visit). These visits are used to understand the long term effects of the training program on the participants. These visits will be conducted three months after the 13th visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
The PT, who evaluates the participants, is blinded for their previous training experience.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older;
- •unilateral bower limb amputee
- •K-level 2 or higher (who are frequent prosthesis users and may benefit from the proposed prosthesis training and use of dEMG controlled powered prosthesis)
- •Amputation occurred over 2 years ago
- •At least 1 year of experience using their prosthetic leg
- •Has used the current socket for at least 6 months without a significant skin issue or major modification
- •Are willing to come to NC State University's Centennial Campus to participate in research and be photographed while doing research activities
排除标准
- •Have a very short residual shank (the length of the residual limb is ≤15% of the length of intact limb)
- •Cannot perform functional ambulation in the community on a daily basis without assistive devices
- •Cognitive or visual impairment that affects the participant's ability to provide informed consent or to follow simple instructions during the experiments
- •Congenital amputees
- •Amputees who use powered prosthetic ankles
- •Weight more than 300lbs
- •Pregnant Person
- •Allergic to latex, which is often contained in medical tapes.
研究组 & 干预措施
Passive group
Patients go through the training procedure with their own passive prosthetic ankles
干预措施: PT guided prosthetic training (Behavioral)
dEMG group
Patients go through the training procedure with the direct EMG controlled powered prosthetic ankle.
干预措施: direct EMG controlled prosthetic ankle (Device)
dEMG group
Patients go through the training procedure with the direct EMG controlled powered prosthetic ankle.
干预措施: PT guided prosthetic training (Behavioral)
结局指标
主要结局
aCOM, anticipatory Center of Mass Excursion when the expected disturbance is introduced
时间窗: Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices
This measurement is to quantify the movement of the COM at the time when the disturbance is introduced and represents an important element of the capability of the participants to conduct anticipatory. Higher value indicates better capacity to conduct anticipatory postural control.
次要结局
- Frequency of stepping responses(Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices)
- Zero-time-lag cross correlation coefficients for bilateral ankle torque(Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices)
- Prosthesis Embodiment Scale(Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices)
- Scores from MiniBES Test (Balance Evaluation Systems Test )(Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices)
- Average muscle modules structure correlation(Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices)
- Scores from Amputee Mobility Predictor (AMP) Test(Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices)
研究者
He Huang
Professor
North Carolina State University