NCT05244863

Brief Summary

Essential tremor is one of the most common movement disorders in the world and is characterized by postural and/or kinetic tremor. Although the prevalence studies show differences due to the absence of a biological marker of the disease, it has been shown that the disease affects 4% of the population over 40 years of age and this rate may increase up to 14% in the population over 65 years of age. The annual incidence of Essential Tremor was found to be 616 per 100 thousand. The incidence of the disease increases with age. An incidence study shows that the disease increases progressively with age, with a sharp increase after age 49. In another study, it was stated that the age of onset of the disease showed a bimodal distribution, reaching the highest level in the second and sixth decades. It is stated that the severity and disability of tremor increase with age. The female-to-male ratio of the disease was found to be equal, but it was shown that more head tremor developed in females. Although the factors affecting essential tremor are aging, stress, family history, excessive caffeine consumption, smoking, muscle weakness, distal and proximal muscle strength differences were detected in young individuals with tremor. The aim of this study was to investigate the relationship between proximal and distal muscle strength and upper extremity functional skills in geriatric individuals with essential tremor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
Last Updated

February 17, 2022

Status Verified

February 1, 2022

Enrollment Period

12 months

First QC Date

February 8, 2022

Last Update Submit

February 8, 2022

Conditions

Keywords

muscle strengthGeriatric individualsFunctional manual dexterity

Outcome Measures

Primary Outcomes (5)

  • ahn-Tolosa-Marin Tremor Rating Scale

    It is a widely used clinical assessment scale for tremor. The severity of tremor body parts is determined as 5 grades from 0 (absent) to 4 (severe)

    At baseline

  • Proximal muscle strength

    Digital dynamometer was used to evaluate muscle strength.

    At baseline

  • Dİstal muscle strength

    Jamar dynamometer was used to evaluate muscle strength.

    At baseline

  • Disability Arm Shoulder Hand

    The DASH-T questionnaire is completed by the individual and consists of 3 parts: the functional/symptom (DASH-FS), the business model (DASH-W), and the sports-musicians model (DASH-SM). The person answers all questions according to a 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: not able to do at all). A score between 0-100 is obtained from each section. The higher the score, the higher the disability.

    At baseline

  • Nine Holes Peg test

    The test is performed with the patient in a sitting position. The patient is asked to line up the nine sticks inside the box on the table as quickly as possible into the holes of the other box, and remove them immediately after finishing. The test is started with the dominant hand, the time is measured with a stopwatch, and it is started when the hand touches the bars and ends when the last stick is placed in the box.

    At baseline

Study Arms (1)

One group

Geriatric individuals

Other: Test

Interventions

TestOTHER

Measurements

One group

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

geriatric individuals with and without tremor

You may qualify if:

  • Voluntary geriatric individuals aged 60-85 years with and without tremor
  • with a mini mental test score above 24,

You may not qualify if:

  • have diabetic neuropathy
  • have undergone hand surgery
  • upper and lower motor paralysis
  • a history of hand fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sutcu Imam University

Kahramanmaraş, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Zekiye İpek Katırcı Kırmacı

    Kahramanmaras Sutcu Imam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

February 8, 2022

First Posted

February 17, 2022

Study Start

March 15, 2020

Primary Completion

March 1, 2021

Study Completion

March 15, 2021

Last Updated

February 17, 2022

Record last verified: 2022-02

Locations