NCT03618433

Brief Summary

The main objective of the study is to investigate the effects of Kinect® video based technology on pain, functionality, muscle strength, fatigue and quality of life in patients with breast cancer surgery and axillary node dissection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

July 30, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

September 3, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2019

Completed
Last Updated

November 14, 2019

Status Verified

November 1, 2019

Enrollment Period

11 months

First QC Date

July 30, 2018

Last Update Submit

November 13, 2019

Conditions

Breast CancerUpper Extremity DysfunctionMastectomy

Keywords

kinectbreast cancermastectomyupper extremity dysfunction

Outcome Measures

Primary Outcomes (1)

  • Range of motion

    Shoulder range of motion will be evaluated by digital goniometer. Shoulder flexion degree, shoulder extension degree, abduction and adduction degree, internal rotation and external rotation degree will be assessed with digital goniometer. The results will be recorded in degrees.

    6 weeks

Secondary Outcomes (5)

  • Pain - Visual Analogue Scale-

    6 weeks

  • Muscle strength

    6 weeks

  • Circumference

    6 weeks

  • Grip strength

    6 weeks

  • Fatigue

    6 weeks

Other Outcomes (3)

  • Disabilitiy

    6 weeks

  • Kinesiophobia

    6 weeks

  • Qualitiy of Life - European Organization for Research and Treatment of Cancer EORTC QLQ-C30 - EORTC- BR23

    6 weeks

Study Arms (2)

Study group

EXPERIMENTAL

Standart exercise protocol and KİNECT® video based physiotherapy The treatment protocol of the study group will consist of soft tissue massage, passive mobilization, stretching, self-stretching exercises.In total, a 25-minute Kincet® video game program will be applied in addition to the 15-minute basic and standart exercise program.

Other: study group

Control group

ACTIVE COMPARATOR

Standart exercise protocol and Upper extremity rehabilitation The control group included soft tissue massage, stretching, self-stretching, passive mobilization, coordination, posture exercises, progressive active and assisted shoulder exercises, proprioception and strengthening exercises in the exercise therapy protocol

Other: Control group

Interventions

study groupOTHER

The treatment protocol will consist of soft tissue massage, passive mobilization, stretching, self-stretching exercises. and shoulder proprioception .In addition to the standart exercise therapy, Kincet® video game program will be applied .

Also known as: Kinect based therapy and standart exercise
Study group
Control groupOTHER

The control group included soft tissue massage, stretching, self-stretching, passive mobilization, coordination, posture exercises, progressive active and assisted shoulder exercises, proprioception and strengthening exercises in the exercise therapy protocol

Also known as: Standart exercise and upper extremity rehabilitation
Control group

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients diagnosed with breast cancer and having axillary lymph node dissection,
  • Post -operative in two weeks,
  • VAS score\>1,
  • Women who do not present contraindications for physiotherapy (infection, metastasis, locoregional recurrence)
  • Women who have read, understood and signed informed consent freely

You may not qualify if:

  • Patients who had breast cancer surgery contralateral or the same side before
  • active or metastatic cancer centers
  • a neurological condition or orthopedic surgery that affects upper extremity function
  • pacemaker, infection, open wound,
  • Women with cognitive limitations to understand the information provided, instructions for treatment and consent to their participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Okemeydanı Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Feyzioglu O, Dincer S, Akan A, Algun ZC. Is Xbox 360 Kinect-based virtual reality training as effective as standard physiotherapy in patients undergoing breast cancer surgery? Support Care Cancer. 2020 Sep;28(9):4295-4303. doi: 10.1007/s00520-019-05287-x. Epub 2020 Jan 6.

    PMID: 31907649DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

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

Study Record Dates

First Submitted

July 30, 2018

First Posted

August 7, 2018

Study Start

September 3, 2018

Primary Completion

August 1, 2019

Study Completion

August 5, 2019

Last Updated

November 14, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)