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Gait and Falling Risk in Patient With Stroke

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07038421
Enrollment
86
Registered
2025-06-26
Start date
2025-04-01
Completion date
2025-05-15
Last updated
2025-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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.

Interventions

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

OTHERGait

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

OTHERSpasticity

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.

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.

OTHERPlantar 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.

Sponsors

Ankara Yildirim Beyazıt University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Gait abilityone hourThe 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

MeasureTime frameDescription
SpasticityOne hourSpasticity was assessed using the MAS. As the MAS score increases, the severity of spasticity increases.
Position senseone hourThe 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.
Plantar senseone hourPlantar sensation was evaluated with the monofilament test. As the monofilament value increases, sensation deteriorates.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026