NCT07155161

Brief Summary

Objective: To examine the relationship between backward walking ability and lower extremity function, proprioception, trunk control, and balance in individuals with stroke. Thirty individuals aged 30-85 who have had a stroke will be included in our study. Individuals with stroke who can walk 10 m without physical assistance, whose lower extremity functions are in the Brunnstrom motor recovery stages 2-6, who have been post-stroke for at least 3 days and up to 24 months, and who score 24 or higher on the Mini Mental Test will be included. Demographic information of individuals with stroke who meet the inclusion criteria will be recorded in a personal information form. Lower extremity function will be evaluated with the 3-meter back walking test (3MGYT), proprioception with the Fugl Meyer lower extremity assessment scale, with a digital goniometer, trunk control with the Trunk Impairment scale, and balance with the Brief BESTTest.

Trial Health

65
Monitor

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
5mo left

Started Sep 2025

Status
not yet recruiting

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 Progress63%
Sep 2025Sep 2026

First Submitted

Initial submission to the registry

August 27, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 4, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2026

Expected
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

August 27, 2025

Last Update Submit

September 5, 2025

Conditions

Keywords

strokeback ward walkingproprioceptiontrunk controlbalance

Outcome Measures

Primary Outcomes (5)

  • 3 meter backward walking

    In the 3MBT, a three-meter distance will be measured on a flat surface and the start and end will be marked. The patient will be asked to walk backward when prompted to start, and will be asked to stop when prompted to stop. Individuals will be allowed to look back if they wish. For safety reasons, the tester will be allowed to walk with the patients. Measurements will be repeated three times and averaged.

    At baseline

  • Fugl-Meyer Lower Extremity Scale

    The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based measure. Measurements are taken with the patient seated on a flat bed, such as a stretcher. Each parameter is scored as 0: Failure, 1: Partially Successful, and 2: Completely Successful. Motor function and sensory sections of the scale are used. The motor function assessment section is scored as 100 points, with 66 for the upper extremities and 34 for the lower extremities, and the sensory assessment section, which includes light touch and position sense, is scored as 24 points. A higher score indicates a better condition. It is a widely used, reliable, and valid test for assessing paretic upper and lower extremity motor impairments in stroke patients.

    At baseline

  • Proprioception

    The patients' range of motion of the hip, knee, and ankle joints on the affected side is measured by fixing a digital goniometer to the joint. Data will be recorded in degrees. Patients will then be asked to half-jointly move their hip, knee, and ankle joints, without being able to see them. The difference between half of the normal joint movement and half of the joint movement performed with eyes closed will be noted. Assessments will be performed in both the prone and supine positions.

    At baseline

  • Trunk Impairment Scale

    The Trunk Impairment Scale is a 17-item scale with three subsections that assess static sitting balance, dynamic sitting balance, and coordination. The starting position for the scale is with the individual in a 90º flexed knee, soles of the feet touching the floor, hands on the thighs, and no back support. Measurements will be repeated three times, and the individual's best results will be recorded. The lowest possible score is 0, and the highest is 23. A high score indicates good trunk control.

    At baseline

  • Brief-Bestest

    It's a low-cost test that can be completed quickly with minimal equipment. It consists of six balance parameters. Measurements are made with a stopwatch on a flat surface. These include biomechanical constraints, stability limitations, transitions-preparatory postural alignment, reactive postural response, sensory orientation, and gait balance. Each question can be scored from a minimum of 0 to a maximum of 3, and the test can achieve a maximum of 24 points.

    At baseline

Study Arms (1)

Stroke

Stroke Patients

Other: Assesment

Interventions

assessment

Stroke

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stroke Patients

You may qualify if:

  • who can walk 10 meters without physical assistance,
  • Lower extremity functions are in stages 2-6 of the Brunnstrom motor recovery scale,
  • Have been at least 3 days and no more than 24 months post-stroke,
  • Scored 24 or higher on the Mini Mental Test

You may not qualify if:

  • Individuals with neurological or orthopedic problems other than stroke that affect walking,
  • A history of cardiovascular or rheumatological diseases that interfere with daily activities,
  • A lower extremity lesion or fracture,
  • Lower extremity spasticity of 4 on the Modified Ashworth Scale (MAS),
  • Aphasia or communication disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

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

August 27, 2025

First Posted

September 4, 2025

Study Start

September 15, 2025

Primary Completion

February 15, 2026

Study Completion (Estimated)

September 25, 2026

Last Updated

September 8, 2025

Record last verified: 2025-09