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NCT Number: NCT07127861

Effects of Treadmill-Based Gait Training in Patients With Stroke

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Salamanca

Salamanca, 37007, Spain

Location status: Recruiting

Location contact

Marta Gómez Mateos

CONTACT

[email protected]

637758887

Marta Gómez Mateos Ms.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Treadmill Gait Training

Other

Participants will undergo a 15-minute treadmill gait training session using a safety harness and under the continuous supervision of a physiotherapist to ensure patient safety. The study will be carried out for 12 weeks with a frequency of two weekly sessions. During them, the participants will receive treadmill training. All participants will walk at a speed exceeding 2.5 km/h. The speed will be individually adjusted to provide a challenging yet appropriate intensity based on each participant's capabilities.

Conventional Physiotherapy

Other

CONVENTIONAL PHYSIOTHERAPY The conventional physiotherapy program was individualized and targeted sensorimotor impairments commonly observed after stroke, with progressive adjustments in exercise intensity and task complexity according to individual performance and tolerance. It included exercises aimed at improving balance, lower-limb muscle strength, coordination, gait performance, and functional task-oriented activities.

Primary outcomes

  1. Thermal asymmetry

    Time frame: 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 outcomes

  1. Walking speed

    Time frame: 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.

  2. Endurance

    Time frame: 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.

  3. Gait Biomechanics and Kinematics

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fátima Pérez Robledo, Doctor

CONTACT

[email protected]

+34 619 885 479

Marta Gómez Mateos

CONTACT

[email protected]

+34637758887

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Collaborators

  • Colegio Profesional Fisioterapeutas Castilla y León
  • INSTITUTO DE INVESTIGACION BIOMEDICA DE SALAMANCA (IBSAL)

Registry information

Acronym: TreadmillACV

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 17, 2025
Registry last updated
Mar 31, 2026

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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