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临床试验/NCT07154472
NCT07154472已完成不适用

Upper Extremity Function in Individuals With Paraplegia: Relationships Between Endurance, Performance, and Symptoms

Hacettepe University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年1月15日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
ASIA Scale

研究概览

简要总结

Spinal cord injury (SCI) is a serious condition that causes physical, psychological, and social functional impairments. Paraplegia is characterized by the loss of motor and/or sensory function at the thoracic, lumbar, or sacral levels of the spinal cord, affecting the trunk, lower extremities, and pelvic organ functions. Functional independence and the ability to use a wheelchair are primary goals of rehabilitation. In paraplegia, the upper extremities are preserved; however, overuse often leads to shoulder and wrist pain and overuse injuries such as carpal tunnel syndrome. Pain is the most common symptom negatively impacting patients' quality of life. Additionally, findings such as decreased muscle strength, spasticity, atrophy, and joint limitations reduce functional performance. This study aims to investigate the relationships between upper extremity function (endurance and performance) and symptoms including pain, sensory loss, atrophy, joint limitations, and grip strength in individuals with paraplegia. Assessment methods used include the ASIA scale, 6-Minute Pegboard and Ring Test, Purdue Pegboard Test, DASH questionnaire, hand dynamometer, and Functional Independence Measure (FIM).

详细描述

Spinal cord injury (SCI) is a devastating condition that can cause physical, psychological, and social functional impairments. Paraplegia, a type of spinal cord injury, refers to the impairment or loss of motor and/or sensory functions of the thoracic, lumbar, or sacral spinal cord segments due to damage to neural structures within the spinal canal. Depending on the injury level, involvement of the trunk, lower extremities, and pelvic organs may occur.

Individuals with spinal cord injury need to have a good level of functional independence and the ability to use a wheelchair effectively in order to maintain their daily lives. Since individuals with SCI often rely heavily on wheelchairs during ambulation and daily activities, continuous load is placed on the bones, joints, and soft tissues of the upper extremities, which may lead to various upper limb problems.

Pain is the most common symptom affecting the quality of life in individuals with spinal cord injury. Additionally, shoulder pain, nerve neuropathies, motor and sensory loss, carpal tunnel syndrome, and muscle weakness can also be observed in these individuals.

Since paraplegic individuals must use a wheelchair, good upper extremity endurance is essential. However, there is a lack of studies in the literature assessing upper extremity endurance in this population. The performance of paraplegic individuals during daily activities is also important, yet no studies evaluating upper extremity performance in paraplegic individuals have been found. Our study is unique in that it aims to assess upper extremity endurance and performance in individuals with paraplegia.

In this study, the relationships between upper extremity function-endurance and performance-and symptoms such as pain, sensory loss, atrophy, joint restrictions, and grip strength associated with paraplegia were evaluated. The primary aim was to identify factors that hinder improvements in quality of life and independence by revealing the relationship between endurance, performance, and symptoms, and to provide data for rehabilitation programs to enhance the quality of life for these patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Individuals with paraplegia who use a wheelchair
  • Classified as ASIA Impairment Scale grade A, B, or C
  • Fully or partially dependent on a wheelchair
  • Over 18 years of age
  • Possessing sufficient upper extremity muscle strength required for wheelchair use

排除标准

  • Individuals with spinal cord injuries outside the T6-T12 levels
  • Presence of respiratory system diseases
  • Presence of cognitive impairment

结局指标

主要结局

ASIA Scale

时间窗: Day 1

The most sensitive method for evaluating a patient with spinal cord injury is a standardized physical examination. The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), developed by the American Spinal Injury Association (ASIA) and also endorsed by the International Spinal Cord Society (ISCoS), has become the most widely used standardized clinical assessment and classification method worldwide in recent years.

6-Minute Pegboard and Ring Test (6PBRT)

时间窗: Day 1

Unsupported functional arm exercise capacity was assessed using the 6-Minute Pegboard and Ring Test (6PBRT). During the 6PBRT, patients sat in front of a board with two bars placed at individual shoulder height and width, with two additional bars positioned 20 cm above these, each holding ten rings. Participants were asked to practice by placing several rings before the test began. They were then instructed to move the rings as quickly as possible from the lower holes to the upper holes and back again for 6 minutes. Standardized encouragement was given every minute during the test. Systolic blood pressure (SBP), diastolic blood pressure (DBP) were measured using an aneroid sphygmomanometer (Erka, Bad Tölz, Germany), while heart rate (HR) and oxygen saturation (SpO2) were monitored with a pulse oximeter (Nonin Palmsat® 2500 series, Plymouth, MN, USA) both before and after the test. Perceived dyspnea, general fatigue, and arm fatigue were recorded using the Modified Borg Scale (mBS/0-10

PURDUE PEGBOARD TEST

时间窗: Day 1

After injuries, limitations in functional activities requiring fine motor skills that are commonly used in daily life have created the need to assess this function. The Purdue Pegboard Test, which evaluates fine motor skills, has become established in the healthcare field. It is suitable for assessing hand functions. The test consists of 5 subtests. One of these includes only a mathematical total score, while in the other 4 subtests, the individual actively performs tasks: Placing pins with the dominant hand (for 30 seconds) Placing pins with the non-dominant hand (for 30 seconds) Placing pins with both hands simultaneously (for 30 seconds) Mathematical total Placing pins, washers, and nuts (for 60 seconds) The test score is the total number of pins or pins, washers, and nuts placed at the end of the allotted time.

DASH Questionnaire

时间窗: Day 1

The Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) was developed in 1994 by the American Academy of Orthopaedic Surgeons (Hudak et al., 1996) to evaluate functional status and symptoms by focusing on physical function in upper extremity injuries. The DASH questionnaire consists of three sections. The first section contains 30 questions; 21 questions assess the patient's difficulty during daily living activities, 5 questions evaluate symptoms (pain, activity-related pain, tingling, stiffness, weakness), and the remaining 4 questions assess social function, work, sleep, and patient confidence. This first section determines the patient's Function/Symptom (DASH-FS) score. According to the DASH questionnaire results, a score between 0 and 100 is obtained for each section (0 = no disability, 100 = maximum disability).

Grip Strength

时间窗: Day 1

For the assessment of grip strength, the Jamar hand dynamometer (Fabrication Enterprises, New York, USA) was used, which is recommended by the American Society of Hand Therapists and is widely recognized in the literature for its high validity and reliability; therefore, it is considered the gold standard. Measurements were taken with the participant seated in an upright, supported position, with the elbow flexed at 90°, the arm adducted to the trunk, and the forearm in a neutral position. Assessments were performed three times for both the dominant and non-dominant hands, with a one-minute rest period between each measurement. The mean value of the three trials was recorded in kilograms-force (kgF) for both the affected and unaffected sides. In the interpretation of the results, the percentage of normative values based on age and gender was used.

Functional Independence Measure (FIM)

时间窗: Day 1

The Functional Independence Measure (FIM) is a widely used assessment tool developed to evaluate the level of functional independence in individuals with physical disabilities. It consists of 18 items, grouped under two major domains: motor (13 items) and cognitive (5 items). The motor domain includes self-care, sphincter control, mobility, and locomotion, while the cognitive domain evaluates communication and social cognition. Each item is scored on a 7-point ordinal scale, where: 1 = total assistance required, 7 = complete independence. The total FIM score ranges from 18 to 126, with higher scores indicating greater functional independence. FIM is commonly used in rehabilitation settings to track patient progress, evaluate treatment effectiveness, and plan discharge and follow-up care.

Assessment of Physical Activity Level: Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)

时间窗: Day 1

The Physical Activity Scale for Individuals with Physical Disabilities (PASIPD) is a 13-item self-report questionnaire assessing daily activities, household tasks, and occupational roles over the past 7 days. It includes activities such as leisure-time exercise, sports, household chores, caregiving, and work-related tasks. Participants report the frequency (never to often) and duration (\<1 hour to \>4 hours/day) of each activity. The total score is calculated by multiplying the average time spent on each activity by its corresponding MET value. Item 1 is not scored and is intended for familiarization only.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

HÜSNA GÜZEL

lecturer

Hacettepe University

研究点 (1)

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