Evaluating a test for arm function in pacemaker patients
Evaluation of the Validity and Reliability of the '6 Minute Pegboard and Ring Test' Unsupported Arm Function Exercise Test in Patients Using Pacemakers
Erol Olcok Corum Training and Research Hospital · NCT06783023
This study is testing a new arm function test to see if it can help people who have had a pacemaker surgery understand any problems they might have with their arm movement.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Erol Olcok Corum Training and Research Hospital (other) |
| Locations | 1 site (Çorum, Center) |
| Trial ID | NCT06783023 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the validity and reliability of the '6 Minute Pegboard and Ring Test' (6PBRT) as a method for evaluating upper extremity function in patients who have undergone pacemaker implantation. With the increasing use of cardiac implantable electronic devices (CIED), it is crucial to have an objective assessment tool to measure potential arm dysfunction that may arise post-implantation. The study will involve patients aged 18-65 who meet specific inclusion criteria, and it will focus on determining how effectively the 6PBRT can evaluate arm function in this population. The findings could lead to improved monitoring and management of shoulder dysfunction in CIED patients.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18-65 who have had a pacemaker implanted for at least three months without complications.
Not a fit: Patients with pre-existing shoulder pathologies or significant complications related to their pacemaker may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for assessing arm function in pacemaker patients, leading to better management of shoulder dysfunction.
How similar studies have performed: While there is limited literature on the specific use of the 6PBRT in this context, the need for objective functional assessments in similar populations suggests potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients between the ages of 18-65 who have a pacemaker, * At least 3 months have passed since pacemaker implantation and there are no complications in the last pacemaker control, * Being in NYHA class I-II-III, * Patients with no coordination problems, * Patients who volunteered to participate in the study. Exclusion Criteria: * Patients with a history of shoulder pathologies prior to pacemaker implantation that may restrict movement of the upper limb (conditions such as severe pain around the shoulder, edema or shoulder dislocation that may restrict upper limb movement), * Patients with a history of shoulder surgery (limitation in range of motion), * Patients who have had a cerebrovascular event resulting in mastectomy or arm involvement on the affected side, * Patients with decompensated heart failure, * Patients with a history of ICD inappropriate shock, * Those with acute myocardial infarction, * Patients with malignancy on active treatment, collagen tissue disease receiving systemic steroids, * Chronic kidney disease patients on dialysis with unstable volume load.
Where this trial is running
Çorum, Center
- Hitit University Corum Erol Olçok Training and Research Hospital — Çorum, Center, Turkey (RECRUITING)
Study contacts
- Study coordinator: Gamze N Ahıskalı, Master's degree
- Email: gmzahiskali@gmail.com
- Phone: +905514128687
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiac Implantable Electrical Devices, Upper Extremity Function