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Completed

NCT Number: NCT07038421

Gait and Falling Risk in Patient With Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Yıldırım Beyazıt University

Ankara, Eyalet/Yerleşke, 48300, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive level

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

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

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

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

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.

Primary outcomes

  1. Gait ability

    Time frame: one hour

    The Dynamic Gait Index (DGI) was developed to assess functional stability during gait. The lower score indicating greater impairment in gait. According to the DGI score, the cutoff value for fall risk was 16.5.

Secondary outcomes

  1. Spasticity

    Time frame: One hour

    Spasticity was assessed using the MAS. As the MAS score increases, the severity of spasticity increases.

  2. Position sense

    Time frame: one hour

    The knee position sense (60 degree) was measured using a dual digital inclinometer. An increase in the mean absolute error indicates that position sense is impaired.

  3. Plantar sense

    Time frame: one hour

    Plantar sensation was evaluated with the monofilament test. As the monofilament value increases, sensation deteriorates.

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study title

The Investigation of Lower Extremity Problems, Gait and Falling Risk in Patient With Stroke

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 26, 2025
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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