Effects of Treadmill-Based Gait Training in Patients With Stroke

NCT07127861 | Recruiting

• 1 other identifier: INV-2025-58
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Gait; Thermography; Walking Speed, Mesh id D000072797; Endurance; Step Time and Length; Gait Analysis

Outcome Measures

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

  30 minutes

Secondary Outcomes (3)

• Walking speed

  5 minutes

• Endurance

  30 minutes

• Gait Biomechanics and Kinematics

  10 minutes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Experimental: Intervention Group TREADMILL TRAINING AND CONVENTIONAL PHYSIOTHERAPY

Other: Treadmill gait training; Other: CONVENTIONAL PHYSIOTHERAPY

Control Group

EXPERIMENTAL

CONVENTIONAL PHYSIOTHERAPY

Other: CONVENTIONAL PHYSIOTHERAPY

Interventions

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.

Intervention Group

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.

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Salamanca: lead
• Colegio Profesional Fisioterapeutas Castilla y León: collaborator
• INSTITUTO DE INVESTIGACION BIOMEDICA DE SALAMANCA (IBSAL): collaborator

Study Sites (1)

Universidad de Salamanca

Salamanca, Salamanca, 37007, Spain

RECRUITING

Central Study Contacts

Marta Gómez Mateos

CONTACT

+34637758887; martagomezmateos@usal.es

Fátima Pérez Robledo, Doctor

CONTACT

+34 619 885 479; fatima_pr@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical therapist

Model Details: Randomized clinical trial in which an intervention group will undergo treadmill training and the control group will not receive any intervention.

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 17, 2025
• Study Start: September 14, 2025
• Primary Completion: September 15, 2025
• Study Completion: March 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: From the publication of the results for 10 years

Locations

ES (1)