Gait and Falling Risk in Patient With Stroke

NCT ID: NCT07038421

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-05-15

Brief Summary

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This study focuses on the impact of lower extremity dysfunctions following stroke-such as muscle weakness, spasticity, and sensory impairments-on gait and fall risk. Post-stroke gait is typically slow, asymmetric, and functionally limited due to motor and sensory deficits. Spasticity, particularly in the lower limb muscles like the gastrocnemius, further complicates walking. Sensory issues, including reduced plantar sensation and joint position sense, also contribute to impaired mobility and balance. The study aims to examine the relationship between gait, plantar sensation, knee position sense, and spasticity, and how these factors influence fall risk in stroke patients.

The aim of the study is to investigate the relationship between gait and plantar sensation, knee position sensation, and spasticity based on these results. Another aim is to determine the effects of plantar sensation, knee position sensation, and spasticity on fall risk. We previously hypothesized that there is a relationship between gait and spasticity, position sense, plantar sensation. This study further hypothesizes hypothesises that parameters associated with gait will influence the risk of falls in patients with stroke.

Detailed Description

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Conditions

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Stroke

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Stroke group

Individuals diagnosed with stroke at least 3 months ago by a neurologist

Cognitive level

Intervention Type OTHER

The cognitive function was assessed with the Montreal Cognitive Assessment (MOCA). The total score ranges from 0 to 30, and scores of 21 and above indicate normal cognitive status

Gait

Intervention Type OTHER

The Dynamic Gait Index (DGI) was assessed for gait. The maximum total score is 24, with a lower DGI score indicating greater impairment in functional mobility and gait

Spasticity

Intervention Type OTHER

Spasticity was assessed using the Modified Ashworth Scale (MAS). In the MAS, muscles were recorded as 0, 1, 1, 1+, 2, 3, and 4 according to the resistance they gave to passive movement.

Position sense

Intervention Type OTHER

The position sense was measured using a dual digital inclinometer. The mean absolute error from three trials was recorded. As the mean absolute error increased, position sense deteriorated.

Plantar sense

Intervention Type OTHER

Plantar sensation was evaluated with the Semmes-Weinstein monofilament test (SWMT). The smallest monofilament value felt and correctly identified was recorded as the patient's threshold for light touch and pressure sensation. As the value increases, the underfloor sensation worsens.

Interventions

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Cognitive level

The cognitive function was assessed with the Montreal Cognitive Assessment (MOCA). The total score ranges from 0 to 30, and scores of 21 and above indicate normal cognitive status

Intervention Type OTHER

Gait

The Dynamic Gait Index (DGI) was assessed for gait. The maximum total score is 24, with a lower DGI score indicating greater impairment in functional mobility and gait

Intervention Type OTHER

Spasticity

Spasticity was assessed using the Modified Ashworth Scale (MAS). In the MAS, muscles were recorded as 0, 1, 1, 1+, 2, 3, and 4 according to the resistance they gave to passive movement.

Intervention Type OTHER

Position sense

The position sense was measured using a dual digital inclinometer. The mean absolute error from three trials was recorded. As the mean absolute error increased, position sense deteriorated.

Intervention Type OTHER

Plantar sense

Plantar sensation was evaluated with the Semmes-Weinstein monofilament test (SWMT). The smallest monofilament value felt and correctly identified was recorded as the patient's threshold for light touch and pressure sensation. As the value increases, the underfloor sensation worsens.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Individuals diagnosed with stroke by a specialist neurologist at least 3 months prior to the study
* Aged 18 years or older
* Having a cognitive level of above 21 points on the Montreal Cognitive Assessment (MoCA)
* Able to walk independently, with or without an assistive device
* Volunteering

Exclusion Criteria

* Had any additional neurological disorder other than stroke
* Had a history of surgical intervention involving the lower extremities
* Had an orthopedic or rheumatologic condition affecting the lower extremities.
Minimum Eligible Age

18 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara Yildirim Beyazıt University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ankara Yıldırım Beyazıt University

Ankara, Eyalet/Yerleşke, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2025-01/1115

Identifier Type: -

Identifier Source: org_study_id

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