Breast CancerNCT07894133
Gait Parameters in Breast Cancer Receiving Chemotherapy Patients
An observational study of Breast Cancer and Chemotherapy, run by Adly A Adam at 1 site in Egypt.
Trial summary
Breast cancer is considered the most common type of malignancies, it is the most frequently diagnosed representing around 2.3 million cases. Where, their chemotherapy may cause fatigue affecting the overall quality of patient's life. Read more about this study
- Who is it for?
- Ages 40 to 50 years, women only
- Conditions the study is for
- Breast Cancer, Chemotherapy, Biodex Gait Trainer
- What is being tested?
- Gait parameter assessment
- How many people
- 360 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 1 Mar 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 40 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: 360 female patients aged from 40 to 50 years, suffering from breast cancer and receiving chemotherapy will be randomly selected from National Cancer Institute, Cairo, Egypt
Who may be able to join
- Age ranged from 40 to 50 years old.
- Female patients.
- Suffering from breast cancer, and receiving chemotherapy.
- Will be assessed before chemotherapy, 3 months and 6 months after chemotherapy.
- All enrolled patients will have signed their informed consent signed.
Who cannot join
- No history of prior chemotherapy.
- Current metastases.
- Orthopedic problems that affect balance and gait.
- Diabetic patients with neuritis.
- Peripheral neuropathy.
- Polyarthritis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
National Cancer Institute
Cairo, Cairo Governorate, 11432
Mustafa A Abdelhalim, M.Sc., 01273902755 ext. 010, adampt80a@gmail.com
Noha MK Ahmed, PHD, 035676103 ext. 105, info@pt.cu.edu.eg
About this study
Official title: Assessment of Gait Parameters in Breast Cancer Patients Receiving Chemotherapy
Breast cancer is considered the most common type of malignancies, it is the most frequently diagnosed representing around 2.3 million cases. Where, their chemotherapy may cause fatigue affecting the overall quality of patient's life. Gait and balance are fundamental for activities of daily living and maintaining functional independence.
Read the detailed description
Gait disturbance is one of the side effects that occur after chemotherapy due to various reasons resulting in lower values of quality of life. Chemotherapeutic agents can cause muscle wasting particularly in the lower extremities resulting in reduced strength and balance. Gait dysfunction, and falls may have particularly severe consequences in this population due to comorbidities increasing the risk of fall-related injury. Therefore, this study was designed to assess gait parameters in breast cancer patient receiving chemotherapy to assist in designing on optimal rehabilitation program based on objective data derived from our study for gait dysfunction in breast cancer patients receiving chemotherapy.
- Conditions
- Breast Cancer, Chemotherapy, Biodex Gait Trainer, Gait Parameters
- Being tested
- Gait parameter assessment
- Keywords
- Chemotherapy, Breast cancer, Biodex gait trainer, Gait Parameters, National Cancer Institute
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait parameter assessmentOther
A Biodex Gait Trainer 3 (BIODEX MEDICAL SYSTEMS, INC., New York, NY, model NO. 601-1-M90, EN 60601- 1 USA), is a device which is used to assess the spatiotemporal gait parameters of patients . It consists of a treadmill with an instrumented deck that monitors and records kinematic gait parameters including gait speed, step cycle, step length, and time on each foot (step symmetry). The patient will instructed to stand on the treadmill holding on handrails to ensure safety. Each patient will be asked to walk continuously for 3 minutes, till the evaluation session ended, and the gait trainer slow down gradually until it stopped. Three successive trials will be done for each patient. The mean value of each variable of spatiotemporal parameters of gait [walking speed (meters per seconds), step cycle (cycle per second), step length (meter), and time on each foot (seconds)] will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | 360 female patients aged from 40 to 50 years, suffering from breast cancer and receiving chemotherapy Receives: Other: Gait parameter assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Speed (Meter per second)
Walking Speed in unit of measurement is meter per second.
Measured: One time assessment throughout the study completion an average of 3 months.
Step cycle (cycle per second)
Step cycle: in unit of measurement is Cycle per second.
Measured: One time assessment throughout the study completion an average of 3 months.
Step length (Meter)
Step length in unit of measurement is meter.
Measured: One time assessment throughout the study completion an average of 3 months.
Time on each foot (Seconds)
Time on each foot in unit of measurement is seconds
Measured: One time assessment throughout the study completion an average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Oct 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Adly A Adam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adly A Adam, Cairo University
- Investigators
- Wessam R ElGhamry, Assistant Professor, Study chair, Assistant Professor of Clinical OncologyNesseren A Affiffy, Professor, Study director, Professor of Physical Therapy for SurgeryMostafa A Abdelhalim, B.Sc, Principal investigator, Physical Therapist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894133
- Sponsor's protocol ID
- P.T.REC/012/005542
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Gait Parameters in Breast Cancer Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT07894133
- Acronym / sponsor ID
- P.T.REC/012/005542
- Conditions
- Breast Cancer, Chemotherapy, Biodex Gait Trainer, Gait Parameters
- Keywords
- Chemotherapy, Breast cancer, Biodex gait trainer, Gait Parameters, National Cancer Institute
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Adly A AdamUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 26 Oct 2026 (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.
Breast cancer is considered the most common type of malignancies, it is the most frequently diagnosed representing around 2.3 million cases. Where, their chemotherapy may cause fatigue affecting the overall quality of patient's life. Gait and balance are fundamental for activities of daily living and maintaining functional independence.
Detailed description
Gait disturbance is one of the side effects that occur after chemotherapy due to various reasons resulting in lower values of quality of life. Chemotherapeutic agents can cause muscle wasting particularly in the lower extremities resulting in reduced strength and balance. Gait dysfunction, and falls may have particularly severe consequences in this population due to comorbidities increasing the risk of fall-related injury. Therefore, this study was designed to assess gait parameters in breast cancer patient receiving chemotherapy to assist in designing on optimal rehabilitation program based on objective data derived from our study for gait dysfunction in breast cancer patients receiving chemotherapy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | Other: Gait parameter assessment360 female patients aged from 40 to 50 years, suffering from breast cancer and receiving chemotherapy |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 360 female patients aged from 40 to 50 years, suffering from breast cancer and receiving chemotherapy will be randomly selected from National Cancer Institute, Cairo, Egypt
Key inclusion criteria (5 listed)
- Age ranged from 40 to 50 years old.
- Female patients.
- Suffering from breast cancer, and receiving chemotherapy.
- Will be assessed before chemotherapy, 3 months and 6 months after chemotherapy.
- All enrolled patients will have signed their informed consent signed.
Key exclusion criteria (6 listed)
- No history of prior chemotherapy.
- Current metastases.
- Orthopedic problems that affect balance and gait.
- Diabetic patients with neuritis.
- Peripheral neuropathy.
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 |
|---|---|---|
| Gait parameter assessmentA Biodex Gait Trainer 3 (BIODEX MEDICAL SYSTEMS, INC., New York, NY, model NO. 601-1-M90, EN 60601- 1 USA), is a device which is used to assess the spatiotemporal gait parameters of patients . It consists of a treadmill with an instrumented deck that monitors and records kinematic gait parameters including gait speed, step cycle, step length, and time on each foot (step symmetry). The patient will instructed to stand on the treadmill holding on handrails to ensure safety. Each patient will be asked to walk continuously for 3 minutes, till the evaluation session ended, and the gait trainer slow down gradually until it stopped. Three successive trials will be done for each patient. The mean value of each variable of spatiotemporal parameters of gait [walking speed (meters per seconds), step cycle (cycle per second), step length (meter), and time on each foot (seconds)] will be recorded. | Other | Experimental Group |
Primary outcome
Walking Speed (Meter per second)
Time frame: One time assessment throughout the study completion an average of 3 months.
Walking Speed in unit of measurement is meter per second.
Step cycle (cycle per second)
Time frame: One time assessment throughout the study completion an average of 3 months.
Step cycle: in unit of measurement is Cycle per second.
Step length (Meter)
Time frame: One time assessment throughout the study completion an average of 3 months.
Step length in unit of measurement is meter.
Time on each foot (Seconds)
Time frame: One time assessment throughout the study completion an average of 3 months.
Time on each foot in unit of measurement is seconds
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 26 Oct 2026.
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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.
Wessam R ElGhamry, Assistant Professor study chair
Assistant Professor of Clinical Oncology
Nesseren A Affiffy, Professor study director
Professor of Physical Therapy for Surgery
Mostafa A Abdelhalim, B.Sc principal investigator
Physical Therapist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Chemotherapy, run by Adly A Adam at 1 site in Egypt.
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 5 inclusion and 6 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 Mustafa A Abdelhalim, B.Sc (01273902755 ext. 101, adampt80a@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Speed (Meter per second) (time frame: One time assessment throughout the study completion an average of 3 months.). The study lists 4 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 26 Oct 2026.