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临床试验/NCT07036900
NCT07036900招募中不适用

Effects of Flexion and Extension Type Arm Slings on Walking Kinematics and Balance in Stroke Patients

Ceren Bayrak1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
48
试验地点
1
主要终点
PABLO ® Lower Extremity inertial sensor

研究概览

简要总结

In the clinic, stroke patients are seen to use flexor or extensor type arm slings, but no study was found investigating the effects of these different types of arm slings on walking kinematics and balance. The aim of the presented study was to investigate the effects of different types of arm slings on walking kinematics and balance in stroke patients and to compare them with healthy individuals.

详细描述

Stroke is one of the most common diseases in the world, affecting one in every four people (Campbell & Khatri, 2020). After stroke, approximately 80% of patients experience walking disorders (Algurén et al., 2010). Stroke survivors demonstrate gait disturbances such as reduced walking speed, step length and cadence (Balaban & Tok, 2014). Deterioration in walking kinematics negatively affects daily living activities, confidence, self-care, social roles, family life and reducing quality of life in stroke survivors (Park & Kim, 2019). Additionally, walking disturbances in stoke patients can lead to increased energy expenditure, pain and risk of falling (Balaban & Tok, 2014; Shin et al., 2020). Besides, balance impairments are frequent clinical symptom in stroke survivors. Compared to healthy individuals, stroke patients have lower balance and walking capacity. Accordingly, the risk of falling increases, physical activity and participation reduces in individuals with stroke (Roelofs et al., 2023). Therefore, it is important that walking kinematics and balance in stroke survivors should have similar characteristics to the healthy individuals.

One of the frequently complications after stroke is shoulder subluxations. Shoulder subluxation increases the distance between the acromion and the humeral head, thus delay improvement of upper extremity motor function and decrease proprioception in stroke survivors (Paci et al., 2005). Electrical stimulation, robot-assisted upper extremity rehabilitation and arm slings are the physiotherapy and rehabilitation applications used to prevent shoulder subluxations in stroke patients (Jung & Choi, 2019; Paci et al., 2005). Arm slings are often used to help reposition the humeral head in the glenoid fossa by counteracting gravity on the affected side (Jeong et al., 2022). In addition, it has been stated that arm slings have a positive effect on balance, increase walking efficiency, reduce spasticity and are a painless application in stroke survivors (Acar & Karatas, 2010; Jeong et al., 2022). In the clinic, it has been observed that stroke patients use flexor or extensor type arm slings. However, no study has been found investigating the effects of these different types of arm slings on walking kinematics and balance in stroke patients. The aim of the presented study is to investigate different types of arm slings on walking kinematics and balance in stroke patients and compare with the healthy individuals.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria for EG were: (1) stroke diagnosis, (2) age 18-80, (3) independent ambulation (Functional Ambulation Category-FAS ≥ 2), (4) Modified Ashworth Scale-MAS ≤2 for gastrocnemius and biceps muscles, (5) ability to walk 10 m independently or with assistive device, (6) physician approval for an exercise program.
  • Inclusion criteria for CG: (1) healthy individuals without any additional neurological or orthopaedic diseases that may affect balance and gait, (2) age 18-80, (3) physician approval for an exercise program.

排除标准

  • (1) severe visual impairments, (2) cerebellar involvement, (3) upper extremity Brunnstrom stage ≤ 3, (4) cancer diagnosis, (5) presence of a neurological or orthopedic condition other than stroke, (6) inability to understand and follow commands or lack of cooperation.

结局指标

主要结局

PABLO ® Lower Extremity inertial sensor

时间窗: 8 min.

Inertial measurement unit (IMU) systems have been validated for measuring joint angles and temporal characteristics during lower extremity movements (O'Reilly et al., 2018). Gait parameters, such as stance and swing phase durations, step length, walking speed, and cadence, can be determined using two inertial sensors placed in the shoes. Each shoe is equipped with a PABLO Lower Extremity Inertial Sensor. The sensors measure angular velocity and acceleration at a sampling frequency of 110Hz. Each sensor transmits data via Bluetooth. The sensors are attached to the participants' shoes using custom Velcro straps. It has been found that inertial measurement unit systems work reliably not only in healthy individuals but also in patients, providing accurate results under different pathological gait patterns (Laidig et al., 2021). In our study, gait analysis was conducted to establish reference values by evaluating stroke patients and healthy individuals of the same age.

TYMO ® Balance Plate

时间窗: 8-10 min.

The TYMO® Balance Plate (Tyromotion, Austria) is a standardized balance analysis device used to assess posture and balance in an upright stance. The TYMO® force sensors detect weight shifting and measure the center of pressure, body sway, and load balance on the feet. These data provide indicators of balance, stability, and symmetry. The TYMO® system is a versatile and easy-to-use assessment and treatment tool consisting of the TYMO Therapy Board and software. Participants are required to stand on a platform for 30 seconds and undergo four test positions: 1) feet apart, eyes open, firm support surface; 2) feet apart, eyes closed, firm support surface; 3) feet apart, eyes open, soft support surface/foam; 4) feet apart, eyes closed, soft support surface/foam. Each position was tested once, and the displacement of the center of body mass was measured in centimeters (Dudoniene et al., 2023).

次要结局

  • Timed Up and Go Test(3-5 min.)

研究者

发起方
Ceren Bayrak
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ceren Bayrak

PhD (c)

Istanbul University - Cerrahpasa

研究点 (1)

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