GaitTreadmillACVNCT07127861
Effects of Treadmill-Based Gait Training in Patients With Stroke
A study testing Treadmill gait training and CONVENTIONAL PHYSIOTHERAPY in people with Gait and Thermography, run by University of Salamanca at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait, Thermography, Walking Speed, Mesh id D000072797
- What is being tested?
- Treadmill gait training and CONVENTIONAL PHYSIOTHERAPY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 14 Sep 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Universidad de Salamanca
Salamanca, Salamanca, 37007
Marta Gómez Mateos, 637758887, martagomezmateos@usal.es
Marta Gómez Mateos Ms.
About this study
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.
Read more
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
- Being tested
- Treadmill gait training, CONVENTIONAL PHYSIOTHERAPY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill gait trainingOther
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 PHYSIOTHERAPYOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Experimental: Intervention Group TREADMILL TRAINING AND CONVENTIONAL PHYSIOTHERAPY Receives: Other: Treadmill gait training; Other: CONVENTIONAL PHYSIOTHERAPY |
| Control Group | Experimental | CONVENTIONAL PHYSIOTHERAPY Receives: Other: CONVENTIONAL PHYSIOTHERAPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes
Secondary outcomes (3)
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.
Measured: 5 minutes
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.
Measured: 30 minutes
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start14 Sep 2025
- Primary completion15 Sep 2025
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GaitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial in which an intervention group will undergo treadmill training and the control group will not receive any intervention.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Collaborators
- Colegio Profesional Fisioterapeutas Castilla y León, INSTITUTO DE INVESTIGACION BIOMEDICA DE SALAMANCA (IBSAL)
- Responsible party
- Principal investigator, Marta Gómez Mateos, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127861
- Sponsor's protocol ID
- INV-2025-58
- Acronym
- TreadmillACV
- Status last verified
- Mar 2026
- First submitted
- 10 Aug 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and the CSR will be available from the publication of the results for 10 years in the repository of the University of Salamanca GREDOS.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Treadmill-Based Gait Training in Patients With Stroke
- ClinicalTrials.gov ID
- NCT07127861
- Acronym / sponsor ID
- TreadmillACV / INV-2025-58
- Conditions
- Gait, Thermography, Walking Speed, Mesh id D000072797, Endurance, Step Time and Length, Gait Analysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Collaborators
- Colegio Profesional Fisioterapeutas Castilla y León, INSTITUTO DE INVESTIGACION BIOMEDICA DE SALAMANCA (IBSAL)
- Study start
- 14 Sep 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- Mar 2026 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial in which an intervention group will undergo treadmill training and the control group will not receive any intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Treadmill gait training, Other: CONVENTIONAL PHYSIOTHERAPYExperimental: Intervention Group TREADMILL TRAINING AND CONVENTIONAL PHYSIOTHERAPY |
| Control Group | Experimental | Other: CONVENTIONAL PHYSIOTHERAPYCONVENTIONAL PHYSIOTHERAPY |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treadmill gait trainingParticipants 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. | Other | Intervention Group |
| CONVENTIONAL PHYSIOTHERAPYCONVENTIONAL 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. | Other | Control Group, Intervention Group |
Primary outcome
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
3 secondary outcomes
Walking speed
Time frame: 5 minutes
Endurance
Time frame: 30 minutes
Gait Biomechanics and Kinematics
Time frame: 10 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: Yes. The study protocol and the CSR will be available from the publication of the results for 10 years in the repository of the University of Salamanca GREDOS.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill gait training and CONVENTIONAL PHYSIOTHERAPY in people with Gait and Thermography, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Gómez Mateos (+34637758887, martagomezmateos@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermal asymmetry (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.