NCT07067710

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 25, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

January 9, 2025

Last Update Submit

July 15, 2025

Conditions

Keywords

Motor imageryAction observation

Outcome Measures

Primary Outcomes (6)

  • Sthrength

    The grip strength of the hand of the affected limb shall be studied, using a dynamometer.

    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

    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".

    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.

    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

    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)

    From enrollement to the end of the treatment at 6 weeks and 3 month after

Study Arms (2)

IMOA group

EXPERIMENTAL

The intervention group will participate in the IM-OA23 programme; the combination of motor imagery and action observation therapies.

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.

Interventions

To observe and imaging one action with a video resource. Not virtual reality.

IMOA group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • males, people with active treatments ongoning, other types of cancer, recurrence or metastasis of cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Public University of Navarre

Pamplona, Navarre, 31008, Spain

NOT YET RECRUITING

Public University of Navarre

Pamplona, Navarre, 31008, Spain

RECRUITING

Public University of Navarre

Pamplona, Navarre, 31008, Spain

RECRUITING

Study Officials

  • Paula Escalada-Hernández, PhD

    Public University of Navarra

    STUDY DIRECTOR
  • Nelia Soto-Ruiz, PhD

    Universidad Pública de Navarra

    STUDY DIRECTOR
  • Pilar Arnal-Vallés, Candidate PhD

    Hospital of Navarra

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pilar Arnal-Vallés, Candidate PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2025

First Posted

July 16, 2025

Study Start

February 25, 2025

Primary Completion

April 28, 2025

Study Completion

February 1, 2026

Last Updated

July 16, 2025

Record last verified: 2025-07

Locations