Breast Cancer SurvivorIM-OA23NCT07067710
The Use of Combined Motor Imagery and Action Observation to Evaluate the Influence on Functional Parameters Such as Strength, Range of Motion, Pain or Fear of Movement Among Others, in Females Breast Cancer Survivors.
A study testing Motor imagery combined with action observation in people with Breast Cancer Survivor, run by Fundacion Miguel Servet at 3 sites in Spain.
Trial summary
The aim of this study is to evaluate the effectivity of the combined motor imagery and action observation therapies to improve functional parameters such as strenght, range of motion, pain or fear of movements among others in relation to upper limb in breast cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Survivor
- What is being tested?
- Motor imagery combined with action observation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 3 sitesSpain
- Study dates
- 25 Feb 2025to Feb 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, over 18 years, have suffered breast cancer, have ended active treatments (chemotherapy, radiotherapy, surgery), have pain or functional limitation or lymphedema at upper limb afected.
Who cannot join
- males, people with active treatments ongoning, other types of cancer, recurrence or metastasis of cancer
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites, 3 recruiting
- Not yet recruiting
Public University of Navarre
Pamplona, Navarre, 31008
Pilar Arnal-Vallés, Candidate PhD, +34 948166117, pilararnal3b@gmail.com
Paula Escalada-Hernández, PhD
- Recruiting
Public University of Navarre
Pamplona, Navarre, 31008
- Recruiting
Public University of Navarre
Pamplona, Navarre, 31008
María pilar Arnal Vallés, Candidate PhD, +34 948166117, pilararnal3b@gmail.com
About this study
Official title: Effectiveness of Combined Motor Imagery and Action Observation in Improving Pain, Range of Motion, and Upper Limb Lymphedema in Breast Cancer Survivors. Efectividad de Las Terapias de imaginería Motora y observación de la acción en la Mejora Del Dolor, la Movilidad y el Linfedema de la Extremidad Superior en Supervivientes de cáncer de Mama.
The aim of this study is to evaluate the effectivity of the combined motor imagery and action observation therapies to improve functional parameters such as strenght, range of motion, pain or fear of movements among others in relation to upper limb in breast cancer survivors. The main question it aims to answer is: Will a combined therapy of motor imagery and action observation improve the strenght, rang of motion, pain, limb diameter and fear of movement of the upper limb in breast cancer survivor females? The participants will be part of the IM-OA23 proyect that consist on seeing some diferent videos about upper limb mobility and then they'll have to imagine the movements and to performed themselves. Researches will compare two groups (control group and intervention group) to evaluate the diferences between them.
Read the detailed description
Purpose: The aim of this study is to evaluate the effectivity of a combined motor imagery and action observation protocol at strength, range of motion, limb diamter, and fear of movement of the upper limb of breast cancer survivors.
Methods: A randomised controlled clinical trial will be conducted. Subjects will be randomly assigned to the two randomly assigned to the two treatment groups: intervention (IM-OA23 programme) and control group (usual care).
This study will have pre and post measurements. The intervention consist on a display of diferent videos of upper limb movements and at daily living activities and in a excercise of imagine and doing this movements. The're will be used diferent tools such as a dynamometer, a goniometer, Visual Analogue Scale (VAS) of pain, or TSK questionnaire.
- Conditions
- Breast Cancer Survivor
- Being tested
- Motor imagery combined with action observation
- Keywords
- Motor imagery, Action observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor imagery combined with action observationOther
To observe and imaging one action with a video resource. Not virtual reality.
| Study group | Role | What they receive |
|---|---|---|
| IMOA group | Experimental | The intervention group will participate in the IM-OA23 programme; the combination of motor imagery and action observation therapies. Receives: Other: Motor imagery combined with action observation |
| Control group | No intervention | The control group will follow the usual care from primary care. There are no care programmes for long term cancer survivors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sthrength
The grip strength of the hand of the affected limb shall be studied, using a dynamometer.
Measured: From enrollement to the end of the treatment at 6 weeks and 3 month after
Range of Motion
The measurement of the degrees of movement of the shoulder joint by means of a goniometer. The movements of flexion, abduction and internal and external rotation shall be studied using previously established reference points.
external rotation, using previously established reference points
Measured: From enrollement to the end of the treatment at 6 weeks and 3 month after
Pain intensity
Pain intensity will be measured by Visual Analogue Scale (VAS). Participants will have to score their pain on a range from 0 to 10 where 0 means "no pain at all" and 10 "my pain is as bas as it could possibly be".
Measured: From enrollement to the end of the treatment at 6 weeks and 3 month after
Limb diameter
Limb diameter will be measured by a measuring tape. The measurement is taken at the midpoint between the acromion and the olecranon, the tape being perpendicular to the limb without compressing the area. The midpoint is located with an elbow flexion of 90 degrees and then the measurement is taken with the elbow in extension, the result is expressed in centimetres.
Measured: From enrollement to the end of the treatment at 6 weeks and 3 month after
Fear of movement
Fear of movement will be measured by the TSK questionnaire
Measured: From enrollement to the end of the treatment at 6 weeks and 3 month after
Imagery
Imagery will be assessed using the Movement Imagery Questionnaire revised second edition (MIQ-RS)
Measured: From enrollement to the end of the treatment at 6 weeks and 3 month after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start25 Feb 2025
- Primary completion28 Apr 2025
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer SurvivorStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Instituto de Investigación Sanitaria de Navarra
- Responsible party
- Sponsor
- Investigators
- Paula Escalada-Hernández, PhD, Study director, Public University of NavarraNelia Soto-Ruiz, PhD, Study director, Universidad Pública de NavarraPilar Arnal-Vallés, Candidate PhD, Principal investigator, Hospital of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067710
- Sponsor's protocol ID
- PI_2023/81 Programa IM-OA23
- Other IDs
- PI_2023/81
- Acronym
- IM-OA23
- Status last verified
- Jul 2025
- First submitted
- 9 Jan 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Arnal-Valles MP, Soto-Ruiz N, Bays-Moneo AB, Garcia-Vivar C, Escalada-Hernandez P. Motor Imagery and Action Observation in Breast Cancer Survivors: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Mar 30;15:e85469. doi: 10.2196/85469.
PubMed 41911468
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Combined Motor Imagery and Action Observation in Improving Pain, Range of Motion, and Upper Limb Lymphedema in Breast Cancer Survivors. Efectividad de Las Terapias de imaginería Motora y observación de la acción en la Mejora Del Dolor, la Movilidad y el Linfedema de la Extremidad Superior en Supervivientes de cáncer de Mama.
- ClinicalTrials.gov ID
- NCT07067710
- Acronym / sponsor ID
- IM-OA23 / PI_2023/81 Programa IM-OA23
- Conditions
- Breast Cancer Survivor
- Keywords
- Motor imagery, Action observation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Collaborators
- Fundación Instituto de Investigación Sanitaria de Navarra
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- Feb 2026 (estimated)
- First posted
- 16 Jul 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.
The aim of this study is to evaluate the effectivity of the combined motor imagery and action observation therapies to improve functional parameters such as strenght, range of motion, pain or fear of movements among others in relation to upper limb in breast cancer survivors. The main question it aims to answer is: Will a combined therapy of motor imagery and action observation improve the strenght, rang of motion, pain, limb diameter and fear of movement of the upper limb in breast cancer survivor females? The participants will be part of the IM-OA23 proyect that consist on seeing some diferent videos about upper limb mobility and then they'll have to imagine the movements and to performed themselves. Researches will compare two groups (control group and intervention group) to evaluate the diferences between them.
Detailed description
Purpose: The aim of this study is to evaluate the effectivity of a combined motor imagery and action observation protocol at strength, range of motion, limb diamter, and fear of movement of the upper limb of breast cancer survivors.
Methods: A randomised controlled clinical trial will be conducted. Subjects will be randomly assigned to the two randomly assigned to the two treatment groups: intervention (IM-OA23 programme) and control group (usual care).
This study will have pre and post measurements. The intervention consist on a display of diferent videos of upper limb movements and at daily living activities and in a excercise of imagine and doing this movements. The're will be used diferent tools such as a dynamometer, a goniometer, Visual Analogue Scale (VAS) of pain, or TSK questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMOA group | Experimental | Other: Motor imagery combined with action observationThe intervention group will participate in the IM-OA23 programme; the combination of motor imagery and action observation therapies. |
| Control group | No intervention | –The control group will follow the usual care from primary care. There are no care programmes for long term cancer survivors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female, over 18 years, have suffered breast cancer, have ended active treatments (chemotherapy, radiotherapy, surgery), have pain or functional limitation or lymphedema at upper limb afected.
Key exclusion criteria (1 listed)
- males, people with active treatments ongoning, other types of cancer, recurrence or metastasis of cancer
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 |
|---|---|---|
| Motor imagery combined with action observationTo observe and imaging one action with a video resource. Not virtual reality. | Other | IMOA group |
Primary outcome
Sthrength
Time frame: From enrollement to the end of the treatment at 6 weeks and 3 month after
The grip strength of the hand of the affected limb shall be studied, using a dynamometer.
Range of Motion
Time frame: From enrollement to the end of the treatment at 6 weeks and 3 month after
The measurement of the degrees of movement of the shoulder joint by means of a goniometer. The movements of flexion, abduction and internal and external rotation shall be studied using previously established reference points. external rotation, using previously established reference points
Pain intensity
Time frame: From enrollement to the end of the treatment at 6 weeks and 3 month after
Pain intensity will be measured by Visual Analogue Scale (VAS). Participants will have to score their pain on a range from 0 to 10 where 0 means "no pain at all" and 10 "my pain is as bas as it could possibly be".
Limb diameter
Time frame: From enrollement to the end of the treatment at 6 weeks and 3 month after
Limb diameter will be measured by a measuring tape. The measurement is taken at the midpoint between the acromion and the olecranon, the tape being perpendicular to the limb without compressing the area. The midpoint is located with an elbow flexion of 90 degrees and then the measurement is taken with the elbow in extension, the result is expressed in centimetres.
Fear of movement
Time frame: From enrollement to the end of the treatment at 6 weeks and 3 month after
Fear of movement will be measured by the TSK questionnaire
Imagery
Time frame: From enrollement to the end of the treatment at 6 weeks and 3 month after
Imagery will be assessed using the Movement Imagery Questionnaire revised second edition (MIQ-RS)
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 16 Jul 2025.
- Derived from this study: PubMed 41911468Arnal-Valles MP, Soto-Ruiz N, Bays-Moneo AB, Garcia-Vivar C, Escalada-Hernandez P. Motor Imagery and Action Observation in Breast Cancer Survivors: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Mar 30;15:e85469. doi: 10.2196/85469.
- Individual participant dataSharing planned: Undecided
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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.
Paula Escalada-Hernández, PhD study director
Public University of Navarra
Nelia Soto-Ruiz, PhD study director
Universidad Pública de Navarra
Pilar Arnal-Vallés, Candidate PhD principal investigator
Hospital of Navarra
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor imagery combined with action observation in people with Breast Cancer Survivor, run by Fundacion Miguel Servet at 3 sites 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 1 inclusion and 1 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 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Pilar Arnal-Vallés, Candidate PhD (+34 948166117, pilararnal3b@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sthrength (time frame: From enrollement to the end of the treatment at 6 weeks and 3 month after). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07067710, which also lists 1 linked publication.
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 16 Jul 2025.