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

R

Recep Tayyip Erdogan University Training and Research Hospital

Status

Completed

Conditions

Primary Hyperparathyroidism

Treatments

Diagnostic Test: gait analysis

Study type

Interventional

Funder types

Other

Identifiers

NCT03713671
GO 18/790

Details and patient eligibility

About

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.

Full description

Parathyroid hormone, released from the parathyroid gland, plays an important role in keeping the ionized calcium in between the reference values in body. Precise control of ionized calcium is particularly necessary to ensure the optimal function of physiological processes such as providing intracellular signaling, performing neuromuscular functions and bone metabolism. When there is a decrease in the level of ionized calcium in the systemic circulation due to any reason, increased calcium concentration is maintained as a result of the increased absorption of calcium from the kidneys, bones and intestines into the blood via increased parathyroid hormone. An error caused by any of the components in this regulatory system may cause excessive parathyroid hormone release, causing primary, secondary or tertiary hyperparathyroidism. Primary hyperparathyroidism (PHPT) is a common endocrinological disorder, which is characterized by excessive release of parathyroid hormone, resulting in a defect in the regulation of calcium metabolism. PHPT, is the third most common endocrine disease and is the most common cause of hypercalcemia. Today, PHPT is approximately 0.25-0.66% of the population and it is seen as 3: 1 times more common in women than men. While the incidence of the disease increases with age, it increases dramatically after 50 years of age. The clinical presentation of PHPT ranges from asymptomatic disease to the classical symptomatic disease of renal and / or musculoskeletal complications. Low plasma 25 Hydroxyvitamin D level; bone mineral density, muscle strength, preservation of postural stability and functional performance of the musculoskeletal functions such as disruption caused by the person's walking and balance activities are adversely affected.In addition, fatigue, pain, and body mass index, as a result of the increase in the functional capacity of the person is seriously reduced quality of life and psychosocial status is adversely affected. Although there are studies related to bone mineral density, muscle strength and function, instability, fatigue, etc., which are secondary to PHPT and cause a significant decrease in functional capacity, there is no study to investigate the effect of M. quadriceps Femoris ,which has a key role in the evaluation of functional capacity, muscle fatigue on the gait and balance parameters in the pre and post-treatment period in the literature. The aim of this case-control study is to investigate the effect of Quadriceps Femoris muscle fatigue protocol on gait, gait symmetry and balance parameters before and after parathyroidectomy in patients PHPT and to compare that parameters of these individuals with healthy controls with similar demographic characteristics that included in the control group.

Enrollment

40 patients

Sex

All

Ages

45 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

PHPT Group
Other group
Description:
Spatio-Temporal gait analysis and balance assessment of subjects with Primary Hyperparathyroidism
Treatment:
Diagnostic Test: gait analysis
Control Group
Other group
Description:
Spatio-Temporal gait analysis and balance assessment of healthy subjects
Treatment:
Diagnostic Test: gait analysis

Trial contacts and locations

1

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Central trial contact

Gonul KOC, MD; Melek M. ERDEM, PT, M.Sc.

Data sourced from clinicaltrials.gov

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