NCT06049069

Brief Summary

The aim of our study is to examine the factors affecting the physical activity of individuals with stroke and to draw attention to the importance of these factors in interventions to improve the physical activity level of individuals with stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Typical duration 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

November 22, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

September 15, 2023

Last Update Submit

February 28, 2024

Conditions

Keywords

physical activityfear of fallingbalancesleep quality

Outcome Measures

Primary Outcomes (1)

  • Physical Activity Scale for the Physically Disabled (PASIPD)

    PASIPD is a 13-item personal report form for classification purposes, covering activities of daily living , domestic activities and professional duties in the last seven days.For each item, individuals are asked to remember the number of days these activities were performed in the last 7 days and on average how many hours a day they did these activities.The PASIPD score is found by multiplying the item coefficient determined by the developers of the questionnaire for 2-13 items with the average daily hour.The total score of PASIPD is obtained by summing the PASIPD score obtained for each item.

    7 months

Secondary Outcomes (6)

  • Exercise Benefits/Barriers Scale

    7 months

  • Berg Balance Scale (BBS)

    7 months

  • International Fall Effectiveness Scale (FES-I)

    7 months

  • Fatigue Severity Scale (FSS)

    7 months

  • Beck Depression Inventory (BDI)

    7 months

  • +1 more secondary outcomes

Interventions

physical activity in stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stroke patients

You may qualify if:

  • Being 18 years or older, diagnosed with ischemic or hemorrhagic stroke, at least 4 weeks have passed since the stroke, no communication and cooperation problems (Mini Mental State Test total score ≥24), ability to walk with or without an assistive device.

You may not qualify if:

  • Having received a warning about physical activity restriction by the specialist physician,having another orthopedic or neurological problem that will affect physical activity other than stroke (bone fracture, multiple sclerosis, Parkinson's, etc.),individuals with advanced cardiovascular disease and in whom mobilization is contraindicated were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale University

Kırıkkale, Turkey (Türkiye)

Location

MeSH Terms

Conditions

StrokeMotor ActivitySleep Initiation and Maintenance Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Saniye Aydoğan arslan, Assoc. Prof.

    Kırıkkale University

    PRINCIPAL INVESTIGATOR
  • Şeyma Nur Cellek, Pt

    Kırıkkale High Specialty Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 15, 2023

First Posted

September 21, 2023

Study Start

November 22, 2021

Primary Completion

May 10, 2022

Study Completion

February 28, 2024

Last Updated

February 29, 2024

Record last verified: 2024-02

Locations