Gait and Falling Risk in Patient With Stroke

NCT07038421 | Completed

• 1 other identifier: 2025-01/1115
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Gait ability

  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.

  one hour

Secondary Outcomes (3)

• Spasticity

  One hour

• Position sense

  one hour

• Plantar sense

  one hour

Study Arms (1)

Stroke group

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

Other: Cognitive level; Other: Gait; Other: Spasticity; Other: Position sense; Other: Plantar sense

Interventions

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

Stroke group

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

Stroke group

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.

Stroke group

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.

Stroke group

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.

Stroke group

Eligibility Criteria

• Age: 18 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Stroke patients

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Yıldırım Beyazıt University

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

Location

MeSH Terms

Conditions

Stroke

Interventions

Gait; Proprioception

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Vestibulocochlear Physiological Phenomena; Physiological Phenomena; Sensation; Nervous System Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: April 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 15, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

TU (1)