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临床试验/NCT07407114
NCT07407114已完成不适用

Effects of Different Stimuli Applied to the Forearm Flexor Muscles on Muscle Activation, Hand Grip Strength, Reaction Time, and Hand Function

Lokman Hekim University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年3月30日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Muscle Activation Measurement

研究概览

简要总结

The study will include three separate intervention groups: an ice application group, a vibration application group, and a control group. Accordingly, three groups were randomly generated using the Research Randomizer software.

To determine the group allocation of the participants, individuals will be asked to draw a number from a bag containing numbers, each written only once. The intervention corresponding to the drawn number will be applied to the participant.

All interventions will be administered by the researcher Demet Öztürk, while the outcome measurements will be evaluated by the researchers Seda Baktır Doğan and Mustafa Sarı. The interventions and assessment procedures will be conducted in separate rooms in order to ensure assessor blinding.

Participants included in the study will first complete a Demographic Data Form. This form will record demographic information including age, sex, body weight, height, dominant side, alcohol consumption status, medical history, and family history.

Following the relevant tactile stimulus application, participants' hand grip strength, muscle activation, hand function, and upper extremity reaction time will be assessed.

详细描述

Cold Application (Ice Therapy):

Ice application will be administered to the forearm flexor muscle group. The application will be performed using a gel pack available in the Physiotherapy and Rehabilitation Laboratory. The gel pack will be kept in a refrigerator for at least 20 minutes prior to application. The pack will be placed between wet towels and applied continuously to the target area for 3 minutes (reference).

Vibration Application:

Vibration therapy will be applied using the Compex Fixx 1.0 device. The device has three different vibration speed levels. In the present study, vibration will be applied to the forearm flexor muscle groups for 3 minutes at the first speed level (1500 RPMs; Power: W / Voltage: 12.0 V / Current: 0.28 A / Sound level: 57-60 dB).

Control Group:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Outcomes Assessor)

盲法说明

The assesors are blind to study.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adult individuals aged between 18 and 35 years
  • Voluntary participants who have read and signed the informed consent form will be included in the study

排除标准

  • Individuals with any systemic, inflammatory, neurological, or degenerative disease affecting the upper extremity
  • Individuals with acute inflammation or inflammatory disorders, acute thrombosis, cardiovascular/circulatory diseases, migraine, or epilepsy
  • Individuals with a history of trauma or surgery involving the upper extremity within the past year
  • Individuals who have started using medications within the last 6 months that may affect the nervous or musculoskeletal systems
  • Individuals with implanted metallic foreign bodies in the upper extremity
  • Individuals with a pacemaker
  • Individuals with circulatory disorders in the upper extremity
  • Individuals with any diagnosed sensory impairment
  • Individuals with any health condition (e.g., visual or cognitive impairment) that may prevent the proper completion of the assessments

研究组 & 干预措施

Group-Ice

Experimental

Cold Application (Ice Therapy):

Ice application will be administered to the forearm flexor muscle group. The application will be performed using a gel pack available in the Physiotherapy and Rehabilitation Laboratory. The gel pack will be kept in a refrigerator for at least 20 minutes prior to application. The pack will be placed between wet towels and applied continuously to the target area for 3 minutes (reference).

干预措施: Ice (Other)

Group-Vibr

Active Comparator

Vibration Application:

Vibration therapy will be applied using the Compex Fixx 1.0 device. The device has three different vibration speed levels. In the present study, vibration will be applied to the forearm flexor muscle groups for 3 minutes at the first speed level (1500 RPMs; Power: W / Voltage: 12.0 V / Current: 0.28 A / Sound level: 57-60 dB).

干预措施: Vibration (Other)

Croup-Cont

No Intervention

Control Group:

In the present study, the control group will be planned as a passive control group, and no intervention will be applied. After the baseline measurements, participants will rest in the intervention room for 3 minutes (equal to the duration of the other interventions), followed by post-intervention assessments conducted in the assessment room.

结局指标

主要结局

Muscle Activation Measurement

时间窗: The evaluations were performed at baseline and immediately post-intervention.

Surface (non-invasive) electromyography (EMG) will be used to assess muscle activation using the Trigno™ Wireless System (Delsys Inc., USA). EMG recordings will be obtained from the flexor carpi radialis, flexor carpi ulnaris, flexor digitorum superficialis, and flexor digitorum profundus muscles. Electrode placement on the target muscles will be determined according to the SENIAM recommendations and previously published studies.

Hand Grip Strength Measurement

时间窗: The evaluations were performed at baseline and immediately post-intervention.

Gross hand grip strength will be assessed using an electronic hand dynamometer (Baseline 12-0286 Electronic Smedley Hand Dynamometer, 200 lbs capacity). Measurements will be performed according to the standard testing protocol recommended by the American Society of Hand Therapists. Participants will be seated upright in a chair with back support, with the shoulder adducted and in a neutral position, the elbow flexed at 90°, and the forearm and wrist in a neutral position. The dynamometer will be held vertically, perpendicular to the floor. Participants will be instructed to hold the dynamometer with one hand and squeeze it as forcefully as possible.

次要结局

  • Hand Function Measurement(The evaluations were performed at baseline and immediately post-intervention.)
  • Upper Extremity Reaction Time Measurement(The evaluations were performed at baseline and immediately post-intervention.)

研究者

发起方
Lokman Hekim University
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Seda BAKTIR

Assist. Prof.

Lokman Hekim University

研究点 (1)

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