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

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ClinicalTrials.gov Identifier: NCT03713671
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : October 22, 2018
Sponsor:
Collaborators:
Hacettepe University
Ankara Education and Research Hospital
Information provided by (Responsible Party):
Melek Merve ERDEM, Recep Tayyip Erdogan University Training and Research Hospital

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 and control group will consist of 20 healthy subjects.

Condition or disease Intervention/treatment Phase
Primary Hyperparathyroidism Diagnostic Test: gait analysis Not Applicable

Detailed 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 is a common endocrinological disorder, which is characterized by excessive release of parathyroid hormone, resulting in a defect in the regulation of calcium metabolism. Primary Hyperparathyroidism is the third most common endocrine disease and is the most common cause of hypercalcemia. Today, Primary Hyperparathyroidism 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 Primary Hyperparathyroidism 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 Primary Hyperparathyroidism and to compare that parameters of these individuals with healthy controls with similar demographic characteristics that included in the control group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Official Title: The Effect of Quadriceps Femoris Muscle Fatigue Protocol on Gait and Balance Parameters Before and After Parathyroidectomy in Patients With Primary Hyperparathyroidism
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : January 31, 2019


Arm Intervention/treatment
Study Group
Spatio-Temporal gait analysis and balance assessment of subjects with Primary Hyperparathyroidism
Diagnostic Test: gait analysis
Computerized gait analysis system will use to 3 times to evaluate the spatio-temporal parameters of gait and clinical balance tests will use for evaluating cases' static and dynamic balance parameters before and after Quadriceps Femoris muscle fatigue protocol in the pre and post-treatment period.
Other Name: balance assessment

Control Group
Spatio-Temporal gait analysis and balance assessment of healthy subjects
Diagnostic Test: gait analysis
Computerized gait analysis system will use to 3 times to evaluate the spatio-temporal parameters of gait and clinical balance tests will use for evaluating cases' static and dynamic balance parameters before and after Quadriceps Femoris muscle fatigue protocol in the pre and post-treatment period.
Other Name: balance assessment




Primary Outcome Measures :
  1. Step Length [ Time Frame: 1 week ]
    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.


Secondary Outcome Measures :
  1. Symmetry Index [ Time Frame: 1 week ]
    It's calculated in order to evaluate symmetry and bilateral coordination of gait. The Symmetry Index and Symmetry Angle are interpreted as a complete symmetry if the result is 0. Evaluation of asymmetries observed in the spatio-temporal characteristics, a deviation of at least 10% from the 0 value for exact symmetry.

  2. Static Balance Assessment [ Time Frame: 1 week ]
    The Romberg test will use to assessment for diagnose sensory ataxia, a gait disturbance caused by abnormal proprioception involving information about the location of the joints.

  3. Dynamic Balance Assessment [ Time Frame: 1 week ]
    To determine fall risk and measure the progress of balance, sit to stand, and walking Timed Up and Go Test will use.

  4. Stride Length [ Time Frame: 1 week ]
    It is measured on the line of progression between the heel points of two consecutive footprints of the same foot (left to left, right to right). The unit of measure is centimeters.

  5. Step Width [ Time Frame: 1 week ]
    It is measured from the midline midpoint of the current footprint to the midline midpoint of the previous footprint on the opposite foot.The unit of measure is centimeters.

  6. Foot Progression Angle [ Time Frame: 1 week ]
    It is the angle between the line of progression and the midline of the footprint. This angle is zero if the geometric mid- line of the footprint is parallel to the line of progression; positive, toe-out, when the mid-line of the footprint is outside the line of progression and negative, toe-in, when inside the line of progression. The unit of measure is degrees.

  7. Percentage of Double Support [ Time Frame: 1 week ]
    It is the amount of time that a person spends with both feet on the ground during one gait cycle. It is presented as a percentage of the gait cycle time (% gait cycle). The percentage of time spent in double support decreases as the speed of walking increases.

  8. Percentage of Stance [ Time Frame: 1 week ]
    The stance phase is the weight bearing portion of each gait cycle. It is initiated by heel contact and ends with toe off of the same foot. It is the time elapsed between the first contact and the last contact of two consecutive footfalls on the same foot. It is also presented as a percentage of the gait cycle time (% gait cycle)

  9. Percentage of Swing [ Time Frame: 1 week ]
    It is initiated with toe off and ends with heel strike. It is the time elapsed between the last contact of the current footfall to the first contact of the next footfall on the same foot. It is expressed in seconds (sec) and it is also presented as a percent of the gait cycle (% gait cycle) of the same foot. The Swing Time is equal to the Single Support time of the opposite foot.

  10. Speed [ Time Frame: 1 week ]
    It is obtained after dividing the distance traveled by the ambulation time. It is expressed in centimeters per second (cm/sec)

  11. Cadence [ Time Frame: 1 week ]
    The rate at which a person walk, expressed in steps per minute (step/min). The average cadence is 100 - 115 steps/min.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Study 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713671


Contacts
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Contact: Melek M. ERDEM, PT, M.Sc. +905300659539 melekmerve.erdem@erdogan.edu.tr
Contact: Gonul KOC, MD +905057711757 gonulkoc08@hotmail.com

Locations
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Turkey
Ankara EDucation and Research Hospital Recruiting
Ankara, Cankaya, Turkey, 06100
Contact: Gonul KOC, MD    +903125953000    gonulkoc08@hotmail.com   
Sponsors and Collaborators
Recep Tayyip Erdogan University Training and Research Hospital
Hacettepe University
Ankara Education and Research Hospital
Investigators
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Principal Investigator: Melek M. ERDEM Tayyip Erdogan University Training and Research Hospital
Study Director: Gonul KOC, MD Ankara Education and Research Hospital
Study Director: Semra TOPUZ, Assoc. Prof. Hacettepe University
Study Chair: Mikail K. DEMIREL, MD Ankara Education and Research Hospital
Study Chair: Isilay TASKALDIRAN, MD Ankara Education and Research Hospital
Study Chair: Cavit CULHA, Assoc. Prof. Ankara Education and Research Hospital

Publications:
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Responsible Party: Melek Merve ERDEM, Research Assistant, Recep Tayyip Erdogan University Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03713671     History of Changes
Other Study ID Numbers: GO 18/790
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Clinical Study Report (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.
URL: https://www.researchgate.net/profile/Melek_Erdem2

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Melek Merve ERDEM, Recep Tayyip Erdogan University Training and Research Hospital:
Primary Hyperparathyroidism
Spatio-Temporal Parameters of Gait
Gait Symmetry
Balance

Additional relevant MeSH terms:
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Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases