NCT06943040

Brief Summary

Spinal Cord Injury (SCI) is a severe neurological condition that occurs as a result of traumatic or non-traumatic causes and results in motor, sensory, and/or autonomic dysfunction. The daily life of individuals with SCI often consists of low activity levels, which can cause loss of physical condition. Therefore, the participation of individuals with SCI in exercise is necessary to improve cardiovascular health and function, as well as to increase life expectancy and quality. Determining the strength, endurance, and exercise capacity of the upper extremities in individuals with SCI is an important issue in the management of SCI. One of the tests that serves this purpose is the six-minute pegboard and ring test (6PBRT). Since 6PBRT is used in clinical and research applications in individuals with SCI, it is important to know its validity and reliability. This study aims to investigate the validity and reliability of 6PBRT in individuals with SCI.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

April 28, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

April 17, 2025

Last Update Submit

May 9, 2026

Conditions

Keywords

Spinal cord injury6PBRTValidityReliability

Outcome Measures

Primary Outcomes (8)

  • 6-minute pegboard and ring test

    The 6PBRT is an upper extremity exercise test that evaluates upper extremity functional capacity through unsupported arm activities. The 6PBRT apparatus consists of four bars placed horizontally on the wall, two at shoulder height and the other two 20 centimeters (cm) above shoulder height. Initially, 10 rings are placed on the lower two bars. Participants sit in a chair in front of the apparatus with back support and feet in full contact with the floor. Participants are instructed to move two rings at a time from the lower bar to the upper bar with both hands (one on each side). When 20 rings are placed from the lower bars to the upper levels, participants are asked to return the rings to the lower level. This sequence of movements is repeated for six minutes. The number of rings moved during the test is used as the final score representing performance. Participants are verbally encouraged every minute during the test, and the verbal command is standardized.

    1 week

  • Shoulder flexor muscle strength

    Muscle strength will be measured using a digital dynamometer with the patient in a sitting position. Muscle tests will be repeated three times for each side, and the highest value will be recorded in kg.

    1 week

  • Shoulder abductor muscle strength

    Muscle strength will be measured using a digital dynamometer with the patient in a sitting position. Muscle tests will be repeated three times for each side, and the highest value will be recorded in kg.

    1 week

  • Elbow extensor muscle strength

    Muscle strength will be measured using a digital dynamometer with the patient in a sitting position. Muscle tests will be repeated three times for each side, and the highest value will be recorded in kg.

    1 week

  • Elbow flexor muscle strength

    Muscle strength will be measured using a digital dynamometer with the patient in a sitting position. Muscle tests will be repeated three times for each side, and the highest value will be recorded in kg.

    1 week

  • Handgrip strength

    The participant will be measured using a hand dynamometer in a sitting position. Muscle tests will be repeated three times for each side, and the highest value will be recorded in kg.

    1 week

  • The 20-m propulsion test (MWPT 20m )

    It will be used to evaluate the participants' ability to use a manual wheelchair. A 20-meter track was set up by drawing a line at the beginning and end. Patients were asked to drive their wheelchairs as fast as they could on this 20-meter track. During this time, the evaluator determined how many seconds it took to complete the 20-meter track with a stopwatch, and the results were recorded in seconds.

    1 week

  • Modified Functional Reach Test (mFUT)

    This test is a quick and easy-to-use test that can be used to measure sitting balance in individuals with SCI. The test is performed while the patient is sitting in a wheelchair with their hips, knees, and ankles flexed at 90 degrees. Individuals place their upper extremities at 90 degrees of flexion in the starting position. After measuring with an inflexible tape measure in this position, patients extend as far as they can and measure again. The distance between them is measured and recorded in centimeters. Participants performed flexion and abduction extensions for the right and left upper extremities separately, and the results will be recorded in centimeters (cm).

    1 week

Secondary Outcomes (1)

  • Barthel Index (BI)

    1 week

Study Arms (1)

Study group

Other: There will be no intervention on the participants within the scope of this study.

Interventions

There will be no intervention on the participants within the scope of this study.

Study group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals With Spinal Cord Injury

You may qualify if:

  • At least one year since the spinal cord injury
  • Being an adult (≥18 years old)
  • Injury level between T1 and L5
  • Being a full-time wheelchair (WD) user for mobility

You may not qualify if:

  • \- Have additional medical conditions (upper extremity and shoulder injuries, etc.) that may affect their ability to perform the tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yunus Emre TÜTÜNEKEN

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 17, 2025

First Posted

April 24, 2025

Study Start

April 28, 2025

Primary Completion

June 15, 2025

Study Completion

August 15, 2025

Last Updated

May 12, 2026

Record last verified: 2026-05

Locations