NCT05726656

Brief Summary

PURPOSE: To determine the effect of wii-console based exercise on shoulder ROM of both sides for post-mastectomy patients, and highlighting the effect of dominancy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

February 3, 2023

Last Update Submit

September 17, 2023

Conditions

Postmastectomy Lymphedema

Outcome Measures

Primary Outcomes (1)

  • shoulder range of motion

    flexion, extension, abduction, adduction , internal rotation and external rotation

    4 weeks

Study Arms (2)

wii console based exercise group

EXPERIMENTAL

the patient will recieve wii console based exercise in addition to traditional physical therapy session

Other: traditional physical therapy sessionOther: wii console based exercise

control group

OTHER

the patient will recieve only the traditional physical therapy session

Other: traditional physical therapy session

Interventions

traditional physical therapy sessionOTHER

manual lymph drainage-pneumatic compression and skin care

control groupwii console based exercise group
wii console based exerciseOTHER

execise session using the wii console video games

wii console based exercise group

Eligibility Criteria

Age30 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All the patients will be females.
  • Patients undergone mastectomy with lymph nodes dissection.
  • all developed lymphedema after the surgery.

You may not qualify if:

  • Vision problems.
  • Medically instable patients.
  • Balance disorders.
  • Other musculoskeletal condition of shoulders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Giza, 11432, Egypt

RECRUITING

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

LymphedemaLymphatic DiseasesHemic and Lymphatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Doaa A Atef, PHD

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Doaa A Atef, PHD

CONTACT

01060267094doozy.masr@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for surgery

Study Record Dates

First Submitted

February 3, 2023

First Posted

February 14, 2023

Study Start

November 1, 2022

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)