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临床试验/NCT05279222
NCT05279222撤回不适用

The Influence of Surgical Correction of Foot Deformity on the Effect of Gait Training on Gait Capacity in Chronic Stroke Patients

Sint Maartenskliniek2 个研究点 分布在 1 个国家开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Emory Functional Ambulation Profile score

研究概览

简要总结

Background: Stroke is the leading cause of disability in the western world. In chronic stroke patients, foot deformity such as pes equinovarus is among the most important underlying motor deficits, due to imbalance of muscle strength and activity around the ankle and tarsal joints. Both nationally and internationally, there is relative underuse of surgical treatment options, although in our clinical experience this often has the best outcome. In addition to positive clinical experiences with surgical interventions, we have experienced that before surgery, there is limited effect of gait training on gait capacity. However, we have experienced that after surgery, the restored normal ankle-foot position creates a new window for training opportunities to further improve gait capacity. Therefore, in this exploratory proof of principle study we aim to investigate the effect of surgical correction of post-stroke foot deformity on the (potential) improvement of gait capacity after gait training. Based on clinical experiences, we expect that after surgery, gait training results in a larger improvement in gait capacity compared to before the surgical intervention due to the increased possibilities to improve balance control.

Objective: The primary objective of this study is to compare the effect of gait training on gait capacity (stepping performance, gait adaptability and dynamic balance) before and after surgical correction of post-stroke foot deformity.

Study design: Exploratory proof of principle study with repeated-measures. Study population: Fifteen stroke patients with disabling foot deformity will be recruited from the Gait Expertise Center (LEC) of the Sint Maartenskliniek and Radboudumc.

Intervention: All patients will receive two gait training interventions, each consisting of twelve one hour training sessions. The training sessions will be focussed on improving gait capacity.

Main study parameters/endpoints: Primary outcomes will be gait adaptability as measured with the Emory Function Ambulation Profile (E-FAP), stepping performance as measured with the Timed-Up-And-Go test (TUG) and dynamic balance as measured with the Margin of Stability (MoS).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • > 6 months post onset
  • 18 years or older
  • Functional Ambulation Classification (FAC) => 3: the patient is able to walk without physical support
  • Will undergo a surgical correction of foot deformity

排除标准

  • suffers from any other disorder that seriously affects gait capacity

结局指标

主要结局

Emory Functional Ambulation Profile score

时间窗: 20 minutes

Measure for gait adaptability. The E-FAP consists of five subtasks: a 5-meter walk test on a hard-surfaced floor, a 5-meter walk test on a carpeted floor, an up and go task, an obstacle course, and ascent and descent of four stairs. The subtasks will be completed according to the sequence above and the time it takes to complete each subtask will be recorded. A standardized E-FAP protocol will be used to assess the subtasks of the E-FAP.

Margin of Stability (MoS) (cm)

时间窗: 30 minutes

Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.

Timed-Up-And-Go test (TUG) score (s)

时间窗: 1 minute

Measure for gait capacity.

次要结局

  • Walking Adaptability Ladder Test score(5 minutes)
  • Modified Dynamic Gait Index score(20 minutes)
  • Lyapunov exponent (-)(30 minutes)
  • Foot placement estimator (cm)(30 minutes)
  • Distance between extrapolated center of mass (XCoM) and center of pressure (CoP) in anterior-posterior (AP) and medio-lateral (ML) direction (cm)(30 minutes)
  • Center of mass (CoM) - center of pressure (CoP) inclination angles (degrees)(30 minutes)
  • Step width variability (cm)(30 minutes)
  • Step time variability (s)(30 minutes)
  • Activities-specific Balance Confidence Scale (ABC Scale)(10 minutes)
  • Walking speed (m/s)(30 minutes)
  • Hip-knee-ankle-foot kinematics (degrees)(30 minutes)
  • Peak ankle moment (Nm)(30 minutes)
  • Peak ankle power (W)(30 minutes)
  • Mini-BESTest score(20 minutes)
  • Activity during the training sessions (minutes)(1 minute)
  • Logbook training sessions (training excercises)(15 minutes)
  • Step length (m)(30 minutes)
  • Cadence (steps/minute)(30 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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