NCT05538468

Brief Summary

It was aimed to determine the presence of kinesiophobia that will affect the treatment in stroke patients and to investigate the relationship between these factors and kinesiophobia by examining factors such as postural control, depression, pain, and affected side that may cause kinesiophobia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2022

Completed
8 months until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
Last Updated

September 13, 2022

Status Verified

January 1, 2022

Enrollment Period

5 months

First QC Date

January 13, 2022

Last Update Submit

September 8, 2022

Conditions

Keywords

Kinesiophobiastroke patientsPainPostural controlDepression

Outcome Measures

Primary Outcomes (5)

  • Kinesiophobia Assessment

    VAS Kinesiophobia Assessment were used. The Visual Analog Scale was used as the second method in the assessment of kinesiophobia. A scale is drawn on a 10-centimeter (cm) horizontal line to show the start as 0 (no fear of movement) and the end as 100 (violent fear of movement). They were asked to stand up just before starting the exercise and to mark the severity of the fear of movement they felt at that moment on the scale.

    6 mounts

  • Kinesiophobia Assessment

    Tampa Kinesiophobia Scale were used. The Tampa Kinesiophobia Scale (TKS) is one of them, and it's commonly used in the literature to assess kinesiophobia. It has 17 questions designed to assess fear of moving.

    6 mounts

  • Pain Assessment

    Pain Assessment Visual Analogue Scale (VAS) was used. On a 10-centimeter (cm) horizontal line, start 0 (no pain) and finish 10 (unbearable pain) are marked and the subjects were asked to place a mark on this horizontal line according to the degree of pain they felt. The point marked on the line was then measured with the help of a ruler and recorded as the VAS value in cm.

    6 mounts

  • Postural Control Assessment

    Postural Assessment Scale for Stroke Patients (PASS) was used. The scale, which consists of 12 items, is grouped at 4 different levels (0-3). It is a 2-part scale that assesses the ability to maintain the posture (5 items) and change it (7 items).

    6 mounts

  • Depression Severity Assessment

    Depression Severity Assessment, The Beck Depression Inventory (BDI) was employed, which consists of 21 questions. The scale has a range of 0 to 84 points.

    6 mounts

Study Arms (1)

Stroke Patients Group

The kinesiophobia scores of the patients were evaluated by (Tampa Kinesiophobia Scale) and (Visual Analog Scale- Kinesiophobia Assessment), depression severity (Beck Depression Inventory), postural control (Postural Assessment Scale), pain severity (Visual Analog Scale).

Other: Assessment

Interventions

Thirty stroke patients were included in the study. After the demographic information was obtained from all patients who accepted to participate in the study by complying with the inclusion criteria; The kinesiophobia scores of the patients were evaluated, depression severity, postural control and pain severity.

Stroke Patients Group

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

30 patients who were level 2 and above according to the Functional Ambulation Classification were included in the study.

You may qualify if:

  • individuals who were diagnosed with hemiplegia or hemiparesis after SVO,
  • at least 6 months after SVO,
  • who were Level 2 and above according to the Functional Ambulation Classification,
  • who wanted to participate in the study voluntarily

You may not qualify if:

  • Anyone with a major neurological or rheumatological pathology (polyneuropathy, parkinson's, multiple sclerosis, rheumatoid arthritis, etc.)
  • Affecting the musculoskeletal system other than stroke
  • Who does not allow mental evaluation, cannot fill in the scales,
  • is illiterate, has aphasia, has a history of falling,
  • have any cardiac problems,
  • amputation in the lower extremities,
  • those with active malignancy and related chemo/radiotherapy,
  • the presence of accompanying lower motor neuron or peripheral nerve lesion,
  • any musculoskeletal problem and related pain (lumbar disc herniation, meniscus, etc.),
  • ındividuals with shoulder subluxation, shoulder-hand syndrome
  • those who refused to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

KinesiophobiaPainDepression

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Doctor

Study Record Dates

First Submitted

January 13, 2022

First Posted

September 13, 2022

Study Start

February 10, 2019

Primary Completion

July 15, 2019

Study Completion

July 30, 2019

Last Updated

September 13, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations