The Effect of Tennis Ball on Balance and Quality of Life in Cancer Patients With Neuropathy.
The Effect of Myofascial Release Using a Tennis Ball on Balance and Quality of Life in Cancer Patients With Peripheral Neuropathy: a Randomized Controlled Trial.
1 other identifier
interventional
50
1 country
1
Brief Summary
This research; It was aimed to evaluate the effect of myofascial release using a tennis ball on balance and quality of life in cancer patients who developed peripheral neuropathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cancer
Started Apr 2024
Shorter than P25 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2024
CompletedFirst Posted
Study publicly available on registry
April 19, 2024
CompletedStudy Start
First participant enrolled
April 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2024
CompletedApril 19, 2024
April 1, 2024
1 month
April 16, 2024
April 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
EORTC QLQ C-30- CIPN20 Scale
The patients' quality of life will be evaluated with the EORTC QLQ-C30, which was developed by EORTC for cancer patients and is widely used all over the world. The first 28 of the scale, which consists of three subheadings and 30 questions, namely functional difficulties, symptom control and general well-being, are four-point Likert type, and the answers are given as "Not at all", "Somewhat", "2", Somewhat "3", Very "4". is evaluated. In the 29th and 30th questions of the scale, the patient is asked to evaluate his/her general well-being by using a linear analog scale and giving a value from 1 to 7 ("1" is very bad and "7" is excellent). Functional scale: physical function (questions 1-5), role function (questions 6 and 7), emotional function (questions 21-24), cognitive function (questions 20 and 25) and social function (questions 26 and 27). )consists of subgroups
10 minutes
One Leg Standing Test
During the test, the participant is asked to cross his arms in front of his body and lift one leg without touching the support leg. Initially, his eyes are open. The eyes are fixed in the direction of the head, the participant is asked to close his eyes and is expected to maintain his balance for 30 seconds.
30 seconds
Lateral Reach Test
In the lateral reach test, the participant is asked to turn his back to the wall, stand close to it but not touch it, and keep his arm close to the wall by abducting it at 90 degrees
5 minutes
Pain Assessment
Pain will be assessed with the Visual Analog Scale (VAS) \[20\]. Patients are explained that the number "0" on a 10 cm horizontal line means no pain, and the number "10" means "unbearable pain
1 minutes
Pressure Pain Threshold Assessment
In quantitative pain threshold measurement, a 1 cm2 surface algometer will be used to measure the pressure pain threshold. The algometer is positioned upright, the pressure is increased to 1kg/cm2 at the painful point every three seconds, and the measurements are repeated 3 times with a 30-second rest period in between. The average of 3 measurements is used for analysis.
5 minutes
Two Point Discrimination
Participants will be evaluated in a sitting position with eyes closed using an aesthesiometer (Instrument Company, Lafayette, IN, USA). Evaluation will be made from the trans-metatarsal area, middle of the foot and middle of the heel. It will start from the interval where two points can be easily distinguished. The distance between two points will be reduced in 1 mm intervals until the two points are felt as a single point.
10 minutes
Study Arms (2)
Study
EXPERIMENTALControl
NO INTERVENTIONInterventions
Movement of the Tennis Ball on the Sole of the Foot: The tennis ball is moved under the foot by back and forth movements and by applying pressure. The aim is to briefly keep the pressure of the ball on the body and the stress indicated by the massage on.
Eligibility Criteria
You may qualify if:
- Complaints of peripheral neuropathy among patients who have completed the standard chemotherapy treatment protocol due to colorectal cancer, entered the follow-up process and come to the outpatient clinic for routine control.
- Registered to Selçuk University Faculty of Medicine Hospital Medical Oncology Polyclinic
- Karnofsky Performance Scale must be 80 or above
- Over 25 years old, under 65 years old
- Presence of grade 2 or higher peripheral neuropathy,
- Being conscious and cooperative
- Verbal and written approval to participate in the study after an explanation about the study is made.
You may not qualify if:
- Having any skin sensitivity on hands and feet before
- Refused to participate in the study after making a statement about the study
- Development of peripheral neuropathy due to reasons other than chemotherapy \[tumor compression, nutritional disorders, infections or major systemic disease (diabetes mellitus, etc.)\]
- Bone or spine metastases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ülkü Saygili Düzova
Selçuklu, Konya, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assist. Prof
Study Record Dates
First Submitted
April 16, 2024
First Posted
April 19, 2024
Study Start
April 28, 2024
Primary Completion
June 10, 2024
Study Completion
July 10, 2024
Last Updated
April 19, 2024
Record last verified: 2024-04