Gait and Balance Parameters Before and After Parathyroidectomy in Patients With Primary Hyperparathyroidism

NCT03713671 | Completed

• 1 other identifier: GO 18/790
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate how Quadriceps Femoris muscle fatigue protocol affect the spatio-temporal gait parameters, gait symmetry and balance in individuals with primary hyperparathyroidism before and after parathyroidectomy. Study group will consist of 20 subjects with primary hyperparathyroidism (PHPT) and control group will consist of 20 healthy subjects.

Conditions

Primary Hyperparathyroidism

Keywords

Primary Hyperparathyroidism; Spatio-Temporal Parameters of Gait; Gait Symmetry; Balance

Outcome Measures

Primary Outcomes (1)

• Step Length

  It is measured along the length of the walkway, from the heel center of the current footprint to the heel center of the previous footprint on the opposite foot.The unit of measure is centimeters.

  1 week

Secondary Outcomes (13)

• Stride Length

  1 week

• Static Balance Assessment

  1 week

• Dynamic Balance Assessment

  1 week

• Fatigue Severity

  1 week

• Functional Capacity

  1 week

Study Arms (2)

PHPT Group

OTHER

Spatio-Temporal gait analysis and balance assessment of subjects with Primary Hyperparathyroidism

Diagnostic Test: gait analysis

Control Group

OTHER

Spatio-Temporal gait analysis and balance assessment of healthy subjects

Diagnostic Test: gait analysis

Interventions

gait analysis DIAGNOSTIC_TEST

Computerized gait analysis system will use to evaluate spatio-temporal gait parameters

Control Group; PHPT Group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PHPT group, include cases with a Primary Hyperparathyroidism
• Control group consists of healthy adults with the similar demographic characteristics as study group.

You may not qualify if:

• The presence of osteoarticular deformities
• Walking with assist device
• Having a neurological disease that may affect the performance
• To have significant and irreversible visual deficits
• The body mass index (BMI) is greater than\> 40 kg / m²
• There is an inability to prevent any of the tests
• Individuals with cancer history and chemotherapy (over the last 5 years)
• Plasma creatinine level\> 150 µmol / L
• Use of Cinacalcet or Etalpha
• Having a history of diabetes mellitus

Sponsors & Collaborators

• Recep Tayyip Erdogan University Training and Research Hospital: lead
• Hacettepe University: collaborator
• Ankara Education and Research Hospital: collaborator

Study Sites (1)

Ankara Education and Research Hospital

Ankara, Cankaya, 06100, Turkey (Türkiye)

Location

Related Publications (1)

• Rolighed L, Rejnmark L, Sikjaer T, Heickendorff L, Vestergaard P, Mosekilde L, Christiansen P. No beneficial effects of vitamin D supplementation on muscle function or quality of life in primary hyperparathyroidism: results from a randomized controlled trial. Eur J Endocrinol. 2015 May;172(5):609-17. doi: 10.1530/EJE-14-0940. Epub 2015 Feb 2.

  PMID: 25646406 BACKGROUND

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Interventions

Gait Analysis

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Study Officials

• Melek M. ERDEM

  Tayyip Erdogan University Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Gonul KOC, MD

  Ankara Education and Research Hospital

  STUDY DIRECTOR

• Semra TOPUZ, Assoc. Prof.

  Hacettepe University

  STUDY DIRECTOR

• Mikail K. DEMIREL, MD

  Ankara Education and Research Hospital

  STUDY CHAIR

• Cavit CULHA, Assoc. Prof.

  Ankara Education and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 22, 2018
• Study Start: October 17, 2021
• Primary Completion: May 15, 2023
• Study Completion: August 27, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be available within 6 months with completion of the result report.
• Access Criteria: Requestors will be required to sign a Data Access Agreement.

Locations

TU (1)