Upper Limb Function in Paraplegic Individuals: Exploring Endurance, Performance, and Symptoms

NCT07154472 | Completed

• 1 other identifier: 24-282
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Paraplegia; Endurance; Symptoms

Keywords

upper extremity; paraplegia; performance; symptoms

Outcome Measures

Primary Outcomes (7)

• ASIA Scale

  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.

  Day 1

• 6-Minute Pegboard and Ring Test (6PBRT)

  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

  Day 1

• PURDUE PEGBOARD TEST

  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.

  Day 1

• DASH Questionnaire

  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).

  Day 1

• Grip Strength

  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.

  Day 1

• Functional Independence Measure (FIM)

  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.

  Day 1

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

  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.

  Day 1

Study Arms (1)

Group 1: Individuals with Paraplegia

The neurological impairment level of the individuals was assessed using the American Spinal Injury Association (ASIA) Classification, upper extremity endurance was evaluated with the 6-Minute Pegboard and Ring Test, upper extremity function was measured by the Purdue Pegboard Test, symptoms were assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire, hand grip strength was measured with the Jamar hand dynamometer, functional independence was evaluated by the Functional Independence Measure (FIM), and physical activity level was assessed using the Physical Activity Scale for Individuals with Physical Disabilities.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study was conducted on individuals with paraplegia who applied to the İstinye University Physiotherapy and Rehabilitation Research and Application Center (İSÜFİZYOTEM).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead
• Istinye University: collaborator

Study Sites (1)

Istinye University Physiotherapy and Rehabilitation Practice and Research Center

Istanbul, ZEYTINBURNU, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Paraplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nurgül Dürüstkan Elbasi, asst. prof.

  Istinye University

  STUDY DIRECTOR

• HÜSNA GÜZEL, PT,PhD (c)

  Istinye University

  STUDY CHAIR

• Berra Mina Eskili, student

  Istinye University

  STUDY CHAIR

• Buse Deniz, STUDENT

  Istinye University

  STUDY CHAIR

• OMER KACIRAL, STUDENT

  Istinye University

  STUDY CHAIR

• HÜSNA GÜZEL, PT,PhD (c)

  Istinye University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: September 4, 2025
• Study Start: January 15, 2025
• Primary Completion: October 8, 2025
• Study Completion: October 8, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

TU (1)