NCT06146283

Brief Summary

The trunk, which plays an integral role in postural stabilization, controls extremity movements by providing dynamic stabilization during performance. Trunk stability is thought to be a prerequisite for upper extremity functions and it is assumed that trunk control has an effect on hand functions. There is thought to be a strong relationship between postural control and fine motor functions. There are very few studies in the literature examining the effect of trunk control on hand functions in Parkinson's patients. Based on this, the aim of this study is; To investigate the relationship between trunk control and hand functions.

  • Hypotheses of the study;
  • Ho: There is no relationship between Trunk Control and hand functions in individuals with Parkinson's disease.
  • H1: There is a relationship between Trunk Control and hand functions in individuals with Parkinson's disease

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

November 17, 2023

Last Update Submit

November 17, 2023

Conditions

Outcome Measures

Primary Outcomes (7)

  • Nine Hole Peg Test (9DPT)

    Nine Hole Peg Test (9DPT): It is a valid and reliable skill test frequently used to evaluate upper extremity function.

    1 weeks

  • Hand Grip Strength Measurement

    Hand Grip Strength Measurement: It is recommended by the American Association of Hand Therapists (AETD) for measuring hand grip strength and has been found to have high validity and reliability in many studies and is therefore considered the gold standard.

    1 weeks

  • Hoehn and Yahr Scale (HYS)

    Hoehn and Yahr Scale (HYS):t is a staging system developed by Hoehn and Yahr that provides information in a short time in determining the degree and symptoms of the disease in individuals with Parkinson's disease. The scale value is between 1-5

    1 weeks

  • Mini Mental Test (MMT)

    Mini Mental Test (MMT):The test was produced as a cognitive assessment tool that takes a short time to apply in the examination of the elderly, especially the elderly with delirium and/or dementia, since the tests used to quantitatively evaluate cognitive performance within standard neuropsychiatric examination methods contain too many questions and take more than 30 minutes to apply.

    1 weeks

  • Quick-DASH

    Quick-DASH:It is an evaluation questionnaire that measures activity and participation limitations in all upper extremity disorders. In the survey, patients' difficulties during daily living activities are questioned with 11 questions. Each question has 5 answer options according to difficulty level. If the patient can do the activity without difficulty, he/she marks 1, if he/she has mild difficulty, 2, if he/she has moderate difficulty, 3, if he/she has extreme difficulty, 4, and if he/she cannot do it at all, he/she marks option 5.

    1 weeks

  • Duruöz Hand Index

    Duruöz Hand Index:It consists of 18 questions filled out by patients to evaluate hand disability. This scale includes questions divided into 5 categories: kitchen chores, dressing, personal hygiene, workplace and other activities. Answers are scored as: I don't have difficulty (=0), I have little difficulty (=1), I have some difficulty (=2), I have great difficulty (=3), it is almost impossible to do it (=4), I definitely cannot do it (=5). The total score consists of the sum of all scores. (0-90). High scores indicate impaired hand functions

    1 weeks

  • Trunk Impairment Scale

    Trunk Impairment Scale:This scale consists of three subscales; static-dynamic sitting balance and trunk coordination. GDS value varies between 0-23 and a high score indicates good trunk control.

    1 weeks

Interventions

This device measures hand grip strength. The individual should be in an upright sitting position. There should be no arm support on the sitting surface. ... The knee angle should be 90 degrees. Elbow angle should be 90 degrees. The wrist should be held without deviation. The measurement should be performed 3 times with an interval of 10 seconds.

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We included individuals diagnosed with Parkinson's between the ages of 40-70.

You may qualify if:

  • between the ages of 40 and 70,
  • Being diagnosed with Parkinson's disease by a neurologist,
  • Having a Mini Mental Test score of 24 and above,
  • Modified Hoehn Yahr Scale score is 2 or less than 2,
  • Having no additional neurological or orthopedic disease

You may not qualify if:

  • Individuals with advanced cognitive problems and aphasia,
  • Individuals with additional neurological disorders,
  • Individuals who refuse to participate in the study,
  • Individuals with vision and hearing problems will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanko University

Gaziantep, Şehitkamil, 27500, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

November 17, 2023

First Posted

November 24, 2023

Study Start

June 1, 2023

Primary Completion

April 1, 2024

Study Completion

June 1, 2024

Last Updated

November 24, 2023

Record last verified: 2023-11

Locations