Gait and Balance Parameters Before and After Parathyroidectomy in Patients With Primary Hyperparathyroidism
Primary Purpose
Primary Hyperparathyroidism
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
gait analysis
Sponsored by
About this trial
This is an interventional screening trial for Primary Hyperparathyroidism focused on measuring Primary Hyperparathyroidism, Spatio-Temporal Parameters of Gait, Gait Symmetry, Balance
Eligibility Criteria
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
Sites / Locations
- Ankara Education and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
PHPT Group
Control Group
Arm Description
Spatio-Temporal gait analysis and balance assessment of subjects with Primary Hyperparathyroidism
Spatio-Temporal gait analysis and balance assessment of healthy subjects
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Stride Length
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.
Static Balance Assessment
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. The Static Balance Assessment of the individuals in the PHPT group were assessed before and 3 months after Parathyroidectomy.
Dynamic Balance Assessment
To determine fall risk and measure the progress of balance, sit to stand, and walking Timed Up and Go Test will use. The Dynamic Balance Assessment of the individuals in the PHPT group were assessed before and 3 months after Parathyroidectomy.
Fatigue Severity
The fatigue level that individuals perceived during the performance was recorded using the Fatigue Severity Scale. This is a nine-items questionnaire that assesses the effect of fatigue on daily living. Each item is a statement on fatigue that the subject rates from 1, ' strongly disagree ' to 7, ' strongly agree '.
Functional Capacity
6 Minute Walk test was used to evaluate the functional capacity. The test was performed in a corridor on a flat hard surface of 30 m in length in a straight line. Before the examination, the patient rested for 10 min in a sitting position. It is calculated by measuring the distance that the person walks at the end of this period by asking the person to walk for 6 minutes along a 30 m corridor. In cases of chest pain, dyspnea, leg cramps, excessive fatigue, sweating and wilting, the test should be terminated immediately. The clinician supervising the test instructed the subject on the walking technique and the possibility of taking a rest. At one-minute intervals during the test, the participant received information about the time remaining until the end of the test.
Step Width
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.
Foot Progression Angle
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.
Speed
It is obtained after dividing the distance traveled by the ambulation time. It is expressed in centimeters per second (cm/sec)
Cadence
The rate at which a person walk, expressed in steps per minute (step/min). The average cadence is 100 - 115 steps/min.
Percentage of Double Support
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.
Percentage of Stance
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)
Percentage of Swing
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.
Gait Symmetry
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.
Full Information
NCT ID
NCT03713671
First Posted
October 18, 2018
Last Updated
November 30, 2022
Sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Collaborators
Hacettepe University, Ankara Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03713671
Brief Title
Gait and Balance Parameters Before and After Parathyroidectomy in Patients With Primary Hyperparathyroidism
Official Title
The Effect of Quadriceps Femoris Muscle Fatigue Protocol on Gait and Balance Parameters Before and After Parathyroidectomy in Patients With Primary Hyperparathyroidism
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2021 (Actual)
Primary Completion Date
December 15, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Collaborators
Hacettepe University, Ankara Education and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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 (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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hyperparathyroidism
Keywords
Primary Hyperparathyroidism, Spatio-Temporal Parameters of Gait, Gait Symmetry, Balance
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PHPT Group
Arm Type
Other
Arm Description
Spatio-Temporal gait analysis and balance assessment of subjects with Primary Hyperparathyroidism
Arm Title
Control Group
Arm Type
Other
Arm Description
Spatio-Temporal gait analysis and balance assessment of healthy subjects
Intervention Type
Diagnostic Test
Intervention Name(s)
gait analysis
Intervention Description
Computerized gait analysis system will use to evaluate spatio-temporal gait parameters
Primary Outcome Measure Information:
Title
Step Length
Description
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.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Stride Length
Description
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.
Time Frame
1 week
Title
Static Balance Assessment
Description
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. The Static Balance Assessment of the individuals in the PHPT group were assessed before and 3 months after Parathyroidectomy.
Time Frame
1 week
Title
Dynamic Balance Assessment
Description
To determine fall risk and measure the progress of balance, sit to stand, and walking Timed Up and Go Test will use. The Dynamic Balance Assessment of the individuals in the PHPT group were assessed before and 3 months after Parathyroidectomy.
Time Frame
1 week
Title
Fatigue Severity
Description
The fatigue level that individuals perceived during the performance was recorded using the Fatigue Severity Scale. This is a nine-items questionnaire that assesses the effect of fatigue on daily living. Each item is a statement on fatigue that the subject rates from 1, ' strongly disagree ' to 7, ' strongly agree '.
Time Frame
1 week
Title
Functional Capacity
Description
6 Minute Walk test was used to evaluate the functional capacity. The test was performed in a corridor on a flat hard surface of 30 m in length in a straight line. Before the examination, the patient rested for 10 min in a sitting position. It is calculated by measuring the distance that the person walks at the end of this period by asking the person to walk for 6 minutes along a 30 m corridor. In cases of chest pain, dyspnea, leg cramps, excessive fatigue, sweating and wilting, the test should be terminated immediately. The clinician supervising the test instructed the subject on the walking technique and the possibility of taking a rest. At one-minute intervals during the test, the participant received information about the time remaining until the end of the test.
Time Frame
1 week
Title
Step Width
Description
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.
Time Frame
1 week
Title
Foot Progression Angle
Description
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.
Time Frame
1 week
Title
Speed
Description
It is obtained after dividing the distance traveled by the ambulation time. It is expressed in centimeters per second (cm/sec)
Time Frame
1 week
Title
Cadence
Description
The rate at which a person walk, expressed in steps per minute (step/min). The average cadence is 100 - 115 steps/min.
Time Frame
1 week
Title
Percentage of Double Support
Description
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.
Time Frame
1 week
Title
Percentage of Stance
Description
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)
Time Frame
1 week
Title
Percentage of Swing
Description
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.
Time Frame
1 week
Title
Gait Symmetry
Description
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.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melek M. ERDEM, PT, M.Sc.
Phone
+905300659539
Email
melekmerve.erdem@erdogan.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Gonul KOC, MD
Phone
+905057711757
Email
gonulkoc08@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melek M. ERDEM
Organizational Affiliation
Tayyip Erdogan University Training and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gonul KOC, MD
Organizational Affiliation
Ankara Education and Research Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Semra TOPUZ, Assoc. Prof.
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mikail K. DEMIREL, MD
Organizational Affiliation
Ankara Education and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cavit CULHA, Assoc. Prof.
Organizational Affiliation
Ankara Education and Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Ankara Education and Research Hospital
City
Ankara
State/Province
Cankaya
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gonul KOC, MD
Phone
+903125953000
Email
gonulkoc08@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available.
IPD Sharing Time Frame
Data will be available within 6 months with completion of the result report.
IPD Sharing Access Criteria
Requestors will be required to sign a Data Access Agreement.
IPD Sharing URL
https://orcid.org/0000-0003-4073-3084
Citations:
PubMed Identifier
25646406
Citation
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.
Results Reference
background
Learn more about this trial
Gait and Balance Parameters Before and After Parathyroidectomy in Patients With Primary Hyperparathyroidism
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