Effects of Treadmill-Based Gait Training in Patients With Stroke

Not Applicable

Not yet recruiting

• Conditions: Gait; Thermography; Walking Speed, Mesh id D000072797; Endurance; Step Time and Length; Step Width; Gait Analysis

• Registration Number: NCT07127861
• Lead Sponsor: University of Salamanca

Brief Summary

Hemiplegia is one of the most common sequelae after stroke. Most patients develop thermal asymmetry between the affected and contralateral sides of the body, as well as an asymmetric gait pattern characterized by differences in the duration of gait cycle phases, step length, cadence, and weight distribution between limbs. These patterns result in reduced aerobic capacity, endurance, energy efficiency, and walking speed, negatively impacting the patient's functional abilities.

There are different methodologies for the treatment gait impairments. Among them, treadmill training has been investigated as an effective therapeutic approach to post-stroke rehabilitation.

Treadmill gait training may reduce asymmetry between hemibodies in hemiplegic patients.

For this reason, our aim is to describe the effects of treadmill training on gait, focusing on its impact on thermal asymmetry, walking speed, aerobic endurance, and the biomechanical and kinematic characteristics of gait.

Patients with hemiplegia will undergo treadmill-based gait training to evaluate its influence on the recovery of this sequel of stroke.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-01
• Primary Completion: 2025-08
• Study First Submitted: 2025-08-10
• Study First Submitted QC: 2025-08-10
• Last Update Submitted: 2025-08-10
• Study First Posted: 2025-08-17
• Last Update Posted: 2025-08-17
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Aged between 18 and 80 years
• History of stroke at least six months prior
• Presence of hemiplegia or hemiparesis
• Ability to walk independently or with assistive devices

Exclusion Criteria

• Cognitive impairments interfering with the understanding of treatment procedures
• Inability to get on and maintain position on the treadmill
• Severe heart failure
• Active inflammatory or infectious conditions at the time of evaluation
• Attendance below 80% of scheduled sessions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Thermal asymmetry	30 minutes	Temperature and humidity will be recorded. Participants will arrive 15 minutes early for acclimatization, seated calmly in the assessment room, wearing shorts and without shoes or socks. They must avoid hot baths, creams, talcum powder, cosmetics, physical exercise, stimulants (caffeine, alcohol, nasal decongestants), smoking, and food intake (water allowed) within two hours prior. During this period, informed consent will be obtained and adhesive markers will be placed 1 cm laterally to the regions of interest: anterior thigh (5 cm above patella), anterior leg (5 cm below patella), posterosuperior leg (popliteal fossa), and posteroinferior leg (10 cm above heel).; Thermal images will be taken in standing position (anterior and posterior views) and supine position (plantar surface), using a tripod-mounted camera at standardized distances and heights. For standing images, the camera will be positioned on a tripod at a distance of 2 m from the subject, at a height of 1

Secondary Outcome Measures

Name	Time	Method
Walking speed	5 minutes	The 10-Meter Walk Test (10MWT) will be used to evaluate walking speed. The test will be conducted in a hallway measuring more than 14 meters in length, with at least two meters available before the start line for acceleration and more than two meters after the finish line for deceleration.
Endurance	30 minutes	The 6-Minute Walk Test (6MWT) will be used to measure aerobic endurance. It is a submaximal cardiorespiratory effort test that measures the maximum distance a person can walk on a flat surface in six minutes. Before starting, the patient is instructed to walk as far as possible within six minutes, with the option to rest if needed. The evaluator starts the timer when the patient begins walking, pausing it during any rests and resuming when walking continues. Heart rate and oxygen saturation are recorded every minute, along with any pauses.
Gait Biomechanics and Kinematics	10 minutes	Gait biomechanics and kinematics will be measured through video recordings and analyzed using Kinovea software. Videos will be captured simultaneously from the frontal and sagittal planes while the patient walks along a marked corridor. Cameras mounted on tripods at a height of 70 cm will be positioned at designated points. The patient will walk back and forth between markers spaced one meter apart, ensuring they pass centrally between the markers in the frontal plane. Recordings will be made in slow motion to accurately observe lower limb movements for detailed biomechanical and kinematic analysis.

Trial Locations

Locations (1)

Universidad de Salamanca; 🇪🇸 Salamanca, Spain