Knee OsteoarthritisNCT06398184
Motor Imagery and Action Observation in Patients With Knee Osteoarthritis
A study testing Exercise + motor imagery and action observation and Exercise in people with Knee Osteoarthritis, run by Cardenal Herrera University.
Trial summary
The main objective of this study is to evaluate the effects of an exercise programme combined with motor imagery and action observation, both in the short and long term. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Exercise + motor imagery and action observation and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2024to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosed with severe knee OA (according to the clinical and radiographic criteria of the American College of Rheumatology Guidelines)
Who cannot join
- pain in the contralateral (non-studied) limb (maximum ≥80 of 100 mm on a visual analog scale (VAS) during daily activities),
- undergone another hip or knee joint replacement in the previous year
- any medical condition in which exercise was contraindicated or if they had participated in exercise programs or motor imagery/action observation intervention
Trial locations and contacts
No sites are listed yet.
About this study
The main objective of this study is to evaluate the effects of an exercise programme combined with motor imagery and action observation, both in the short and long term.
- Conditions
- Knee Osteoarthritis
- Being tested
- Exercise + motor imagery and action observation, Exercise
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise + motor imagery and action observationOther
A total of 8 sessions of 4 sets of knee extension exercises will be performed. During the breaks between each series, participants will perform a progressive protocol of action observation and motor imagery.
ExerciseOther
A total of 8 sessions of 4 sets of knee extension exercises will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Exercise + motor imagery and action observation | Experimental | Not described Receives: Other: Exercise + motor imagery and action observation |
| Exercise | Active comparator | Not described Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (Visual analogue scale)
Pain intensity will be measured using a visual analogue scale.
Measured: through study completion, 1 month
Disability (WOMAC scale)
Disability will be measured using WOMAC scale.
Measured: through study completion, 1 month
Algometry
Pressure pain thresholds will be measured by algometry on the affected knee, contralateral knee and epicondyle.
Measured: through study completion, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start15 May 2024 (estimated)
- Primary completion15 Oct 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Suso, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398184
- Sponsor's protocol ID
- MI1
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Imagery and Action Observation in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06398184
- Acronym / sponsor ID
- MI1
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 3 May 2024 (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.
The main objective of this study is to evaluate the effects of an exercise programme combined with motor imagery and action observation, both in the short and long term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise + motor imagery and action observation | Experimental | Other: Exercise + motor imagery and action observation |
| Exercise | Active comparator | Other: Exercise |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed with severe knee OA (according to the clinical and radiographic criteria of the American College of Rheumatology Guidelines)
Key exclusion criteria (3 listed)
- pain in the contralateral (non-studied) limb (maximum ≥80 of 100 mm on a visual analog scale (VAS) during daily activities),
- undergone another hip or knee joint replacement in the previous year
- any medical condition in which exercise was contraindicated or if they had participated in exercise programs or motor imagery/action observation intervention
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 |
|---|---|---|
| Exercise + motor imagery and action observationA total of 8 sessions of 4 sets of knee extension exercises will be performed. During the breaks between each series, participants will perform a progressive protocol of action observation and motor imagery. | Other | Exercise + motor imagery and action observation |
| ExerciseA total of 8 sessions of 4 sets of knee extension exercises will be performed. | Other | Exercise |
Primary outcome
Pain intensity (Visual analogue scale)
Time frame: through study completion, 1 month
Pain intensity will be measured using a visual analogue scale.
Disability (WOMAC scale)
Time frame: through study completion, 1 month
Disability will be measured using WOMAC scale.
Algometry
Time frame: through study completion, 1 month
Pressure pain thresholds will be measured by algometry on the affected knee, contralateral knee and epicondyle.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise + motor imagery and action observation and Exercise in people with Knee Osteoarthritis, run by Cardenal Herrera University.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis Suso-Martí, PhD (627819667, luis.suso@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (Visual analogue scale) (time frame: through study completion, 1 month). The study lists 3 primary outcomes in all. 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 3 May 2024.