NCT06043869

Brief Summary

Falls are the most common cause of injuries and hospitalization for elderly people and can lead to a significant loss of independence. Even in the absence of serious injury, falls may lead seniors to restrict their activities outside of the home for fear of falling again.Tinetti's Falls Efficacy Scale (FES) is the most widely used measure of self-efficacy in studies on falls prevention. Mary E. Tinetti developed this scale to measure the fear of falling. The 10item scale was developed to assess confidence in performing daily activities without falling. Items are rated from 1 ¼ extreme confidence to 10 ¼ no confidence at all. The FES scale has been reported to have excellent internal reliability (Cronbach's alpha ranged between 0.89 and 0.99), with all items loading on a single factor.Test-retest reliability has been reported to be good (ranged from r ¼ 0.71 - 0.90).Criterion validity has been demonstrated by significant associations between FES scores and difficulty getting up after a fall, measures of balance and gait, and activity avoidance. In predictor studies, low FES scores were associated with falls restrictions in social functions and activities of daily living (ADL) reduced physical activity and mobility problems. Tinetti's Falls Efficacy Scale has been translated many languages like Chinese, Iranian, Persian etc. But the Urdu translation is not yet available. To measure the fear of falling in stroke patients Tinetti's Falls Efficacy Scale is a reliable and valid scale..In Neuro rehabilitation clinics the most common issue with the patients who come for rehabilitation is Stroke. So, it is highly required to translate valid and reliable instruments like Tinetti's Falls Efficacy Scale in to Urdu language. So, that patients will be able to understand the questionnaire into their native language and will be able to tell about the actual state of their condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

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

June 8, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

September 12, 2023

Last Update Submit

September 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fear of Falling Avoidance-Behavior Questionnaire

    The Fear of Falling Avoidance-Behavior Questionnaire (FOFABQ), often referred to as the FOFABQ, is a standardized assessment tool used to measure an individual's fear of falling and the extent to which this fear influences their behavior. It is commonly used in healthcare and research settings, particularly with older adults or individuals with a history of falls. Sum the scores for all the questions on the FOFABQ to obtain the respondent's total score. The total score represents the overall level of fear of falling and avoidance behavior. The interpretation of the FOFABQ score may vary depending on the specific version of the questionnaire used and the scoring system adopted in a particular study or clinical setting. Typically, higher scores on the FOFABQ indicate greater fear of falling and more avoidance behavior.

    1 week

Eligibility Criteria

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

Stroke (Ischemic, Hemiplegic both)

You may qualify if:

  • Age 40 to 65 years
  • Both gender
  • Stroke

You may not qualify if:

  • Critically ill patients who are on respirators
  • Neurologically unstable patients
  • Patients who cannot read and understand Urdu language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lahore Teaching Hospital

Lahore, Punjab Province, 55150, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Myra Naeem, MSPTN*

    University of Lahore

    PRINCIPAL INVESTIGATOR
  • Samia Sarmad, tDPT

    University of Lahore

    STUDY DIRECTOR
  • Waqar Afzal, PhD PT*

    University of Lahore

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2023

First Posted

September 21, 2023

Study Start

June 8, 2023

Primary Completion

September 1, 2023

Study Completion

September 8, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations