Effects of Treadmill-Based Gait Training in Patients With Stroke

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Salamanca

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Treadmill gait training

    Other intervention

    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 intervention

    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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 2 interventions
Group B: Control GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Thermal asymmetry

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

Time frame
30 minutes

Secondary outcomes

1

Walking speed

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.

Time frame
5 minutes
2

Endurance

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.

Time frame
30 minutes
3

Gait Biomechanics and Kinematics

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.

Time frame
10 minutes

Other outcomes

Sponsors and contacts

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University of Salamanca

Lead sponsor

Colegio Profesional Fisioterapeutas Castilla y León

Collaborator

INSTITUTO DE INVESTIGACION BIOMEDICA DE SALAMANCA (IBSAL)

Collaborator