NeuropathyNCT07137078
Pilates Versus Gyrotonic Expansion System on Chemotherapy Induced Peripheral Neuropathy and Fall Risk
A study testing pilates and gyrotonic expansion exercise in people with Neuropathy, run by MTI University at 1 site in Egypt.
Trial summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and dose-limiting side effect of neurotoxic chemotherapy (ie, taxanes, vinca alkaloids, platinum, and bortezomib) that interferes with patients' daily function and worsens quality of life (1-3). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuropathy
- What is being tested?
- pilates and gyrotonic expansion exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 5 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years
- Diagnosed with CIPN
- Completed at least 3 cycles of chemotherapy
- Ability to provide informed consent
Who cannot join
- Severe neuropathy requiring pharmacological intervention
- Concurrent participation in another physical therapy regimen
- Any medical condition contraindicating physical exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and dose-limiting side effect of neurotoxic chemotherapy (ie, taxanes, vinca alkaloids, platinum, and bortezomib) that interferes with patients' daily function and worsens quality of life (1-3). In a study of 512 cancer survivors, 47% reported persistent neuropathy up to 6 years after chemotherapy completion. Furthermore, these survivors exhibited altered gait patterns with slower and shorter steps, as well as a fall risk 1.8-fold greater than that of those without CIPN (4). In another study, 12% of cancer survivors with CIPN reported falls within a 3-month period (5). These evidences highlight the need for an effective treatment for CIPN to improve quality of life and safety among cancer survivors. Current empirical treatments for CIPN include symptom management with analgesics, antidepressants, and antiepileptics (6). However, these approaches are limited not only by toxicities but also by patients' reluctance to further medicate a medication-related condition.
Read the detailed description
Pilates can be an effective intervention to address patients received chemotherapy and the associated increased risk of falls. CIPN is a common side effect of certain chemotherapy drugs, characterized by nerve damage that leads to symptoms such as pain, tingling, numbness, and weakness primarily in the hands and feet. These symptoms significantly impact balance and mobility, increasing the risk of falls. Pilates, with its focus on core strength, balance, flexibility, and controlled movement, can help mitigate these effects. The slow, deliberate movements in Pilates improve proprioception and strengthen the core and lower extremities, which are crucial for maintaining balance and stability. Regular Pilates practice can enhance postural alignment and muscle coordination, which can reduce the risk of falls in individuals experiencing CIPN.
Pilates can be an effective intervention to address chemotherapy-induced peripheral neuropathy (CIPN) and the associated increased risk of falls. CIPN is a common side effect of certain chemotherapy drugs, characterized by nerve damage that leads to symptoms such as pain, tingling, numbness, and weakness primarily in the hands and feet. These symptoms significantly impact balance and mobility, increasing the risk of falls. Pilates, with its focus on core strength, balance, flexibility, and controlled movement, can help mitigate these effects. The slow, deliberate movements in Pilates improve proprioception and strengthen the core and lower extremities, which are crucial for maintaining balance and stability. Regular Pilates practice can enhance postural alignment and muscle coordination, which can reduce the risk of falls in individuals experiencing CIPN.
The Gyrotonic Expansion System (GES) is an innovative movement methodology that is gaining attention for its potential benefits in addressing chemotherapy side effects, result in numbness, tingling, and pain in the extremities, significantly affecting balance and increasing fall risk. The GES involves fluid, spiraling movements designed to enhance flexibility, strength, coordination, and balance. By promoting increased circulation and nerve stimulation, these movements may help alleviate the symptoms of chemotherapy, potentially improving patient outcomes. The system's focus on core strength and alignment can also aid in stabilizing posture, thereby reducing the likelihood of falls.
- Conditions
- Neuropathy
- Being tested
- pilates, gyrotonic expansion exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pilatesOther
Pilates exercises, particularly those focusing on core stability, balance, and flexibility, are highly beneficial for individuals at risk of falls. These exercises enhance proprioception, which is the body's ability to sense movement, action, and location, thereby improving coordination and balance. For example, exercises like the "Single Leg Stretch" and "Roll-Up" target the abdominal muscles, which are crucial for maintaining stability. Additionally, "Leg Circles" and "Side Planks" help strengthen hip abductors and stabilizers, contributing to better postural alignment and reducing the likelihood of falls. By regularly incorporating Pilates into a fitness routine, individuals can build strength and confidence, ultimately helping to prevent falls and maintain independence.
gyrotonic expansion exerciseOther
Exercise phase Training Time Warm-Up Gentle, dynamic stretches focusing on the spine, hips, and legs. Gently roll the head from side to side to release tension, Move shoulders in a circular motion to loosen muscles, While standing, rotate the torso gently from side to side, Rotate each ankle in both directions to improve mobility. 5 minutes Core Activation Using pulley rope system the Arch and Curl, to engage the abdominal muscles, Focus on maintaining proper alignment and breathing deeply. 13 minutes Balance and Coordination Using pulley rope system Standing Series, shifting weight, such as the Spiral Sequence, to improve coordination. 12 minutes Flexibility and Range of Motion Leg stretches using the Leg Extension Unit to improve hip and knee range of motion. 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| (Pilates exercise | Experimental | Pilates exercises, particularly those focusing on core stability, balance, and flexibility, are highly beneficial for individuals at risk of falls. These exercises enhance proprioception, which is the body's ability to sense movement, action, and location, thereby improving coordination and balance. For example, exercises like the "Single Leg Stretch" and "Roll-Up" target the abdominal muscles, which are crucial for maintaining stability. Additionally, "Leg Circles" and "Side Planks" help strengthen hip abductors and stabilizers, contributing to better postural alignment and reducing the likelihood of falls. By regularly incorporating Pilates into a fitness routine, individuals can build strength and confidence, ultimately helping to prevent falls and maintain independence. Receives: Other: pilates |
| gyrotonic expansion exercise | Experimental | Exercise phase Training Time Warm-Up Gentle, dynamic stretches focusing on the spine, hips, and legs. Gently roll the head from side to side to release tension, Move shoulders in a circular motion to loosen muscles, While standing, rotate the torso gently from side to side, Rotate each ankle in both directions to improve mobility. 5 minutes Core Activation Using pulley rope system the Arch and Curl, to engage the abdominal muscles, Focus on maintaining proper alignment and breathing deeply. 13 minutes Balance and Coordination Using pulley rope system Standing Series, shifting weight, such as the Spiral Sequence, to improve coordination. 12 minutes Flexibility and Range of Motion Leg stretches using the Leg Extension Unit to improve hip and knee range of motion. 5 minutes Receives: Other: gyrotonic expansion exercise |
| control | No intervention | No traninig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemotherapy Induced Peripheral Neuropathy Assessment Tool
The CIPNAT is a fifty item instrument that contains two sets of items symptom experience items and interference items. The 36 symptom experience items measure severity, distress, and frequency of nine neuropathic symptoms including; numbness in the hands, numbness in the feet, tingling in the hands, tingling in the feet, sensitivity to cold temperatures, nerve pain, muscle/joint aches, muscle weakness and loss of balance. Participants are first asked whether they have developed any of the nine symptoms since receiving chemotherapy. For each symptom reported, participants are asked to rate the intensity, distress, and frequency of that symptom on a 0-10 numeric rating scale. The symptom experience item set is scored by adding the number of symptoms reported (0-9) with the severity, distress, and frequency scores for each reported symptom. Scores range from 0-279 with higher scores corresponding with higher levels of CIPN.
Measured: at baseline and at 12 weeks
Secondary outcomes (3)
Grip Strength
Grip strength will be assessed using a Jamar handheld dynamometer.
Measured: at baseline and at 12 weeks
Dynamic Balance
The Four-Square Step Test (FSST) assesses dynamic balance and fall risk. Scores are interpreted based on the time it takes to complete the sequence, with higher scores indicating a greater risk of falls.
Measured: at baseline and at 12 weeks
Dual Task (DT) Gait Speed
The DT gait speed was conducted similarly to the ST gait speed, with the addition of a cognitive task. There are 2 categories of DT commonly used: mental tracking and verbal fluency. Mental tracking tasks require one to hold information in the mind while performing a mental process, and are commonly used to examine sustained attention, information processing speed, and executive function.21 Verbal fluency tasks require spontaneous word production under specific search conditions and are also thought to examine executive function.21 there are currently no established standards for DT gait assessment. Existing literature advises DT selection based on the tested cohort, taking into consideration background diseases and other socio-demographics such as education level.
Measured: at baseline and at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Oct 2025
- Primary completion1 Jan 2026
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuropathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- RCT
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137078
- Sponsor's protocol ID
- P.T.REC/012/005944
- Status last verified
- Feb 2026
- First submitted
- 16 Aug 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilates Versus Gyrotonic Expansion System on Chemotherapy Induced Peripheral Neuropathy and Fall Risk
- ClinicalTrials.gov ID
- NCT07137078
- Acronym / sponsor ID
- P.T.REC/012/005944
- Conditions
- Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 22 Aug 2025 (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.
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and dose-limiting side effect of neurotoxic chemotherapy (ie, taxanes, vinca alkaloids, platinum, and bortezomib) that interferes with patients' daily function and worsens quality of life (1-3). In a study of 512 cancer survivors, 47% reported persistent neuropathy up to 6 years after chemotherapy completion. Furthermore, these survivors exhibited altered gait patterns with slower and shorter steps, as well as a fall risk 1.8-fold greater than that of those without CIPN (4). In another study, 12% of cancer survivors with CIPN reported falls within a 3-month period (5). These evidences highlight the need for an effective treatment for CIPN to improve quality of life and safety among cancer survivors. Current empirical treatments for CIPN include symptom management with analgesics, antidepressants, and antiepileptics (6). However, these approaches are limited not only by toxicities but also by patients' reluctance to further medicate a medication-related condition.
Detailed description
Pilates can be an effective intervention to address patients received chemotherapy and the associated increased risk of falls. CIPN is a common side effect of certain chemotherapy drugs, characterized by nerve damage that leads to symptoms such as pain, tingling, numbness, and weakness primarily in the hands and feet. These symptoms significantly impact balance and mobility, increasing the risk of falls. Pilates, with its focus on core strength, balance, flexibility, and controlled movement, can help mitigate these effects. The slow, deliberate movements in Pilates improve proprioception and strengthen the core and lower extremities, which are crucial for maintaining balance and stability. Regular Pilates practice can enhance postural alignment and muscle coordination, which can reduce the risk of falls in individuals experiencing CIPN.
Pilates can be an effective intervention to address chemotherapy-induced peripheral neuropathy (CIPN) and the associated increased risk of falls. CIPN is a common side effect of certain chemotherapy drugs, characterized by nerve damage that leads to symptoms such as pain, tingling, numbness, and weakness primarily in the hands and feet. These symptoms significantly impact balance and mobility, increasing the risk of falls. Pilates, with its focus on core strength, balance, flexibility, and controlled movement, can help mitigate these effects. The slow, deliberate movements in Pilates improve proprioception and strengthen the core and lower extremities, which are crucial for maintaining balance and stability. Regular Pilates practice can enhance postural alignment and muscle coordination, which can reduce the risk of falls in individuals experiencing CIPN.
The Gyrotonic Expansion System (GES) is an innovative movement methodology that is gaining attention for its potential benefits in addressing chemotherapy side effects, result in numbness, tingling, and pain in the extremities, significantly affecting balance and increasing fall risk. The GES involves fluid, spiraling movements designed to enhance flexibility, strength, coordination, and balance. By promoting increased circulation and nerve stimulation, these movements may help alleviate the symptoms of chemotherapy, potentially improving patient outcomes. The system's focus on core strength and alignment can also aid in stabilizing posture, thereby reducing the likelihood of falls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| (Pilates exercise | Experimental | Other: pilatesPilates exercises, particularly those focusing on core stability, balance, and flexibility, are highly beneficial for individuals at risk of falls. These exercises enhance proprioception, which is the body's ability to sense movement, action, and location, thereby improving coordination and balance. For example, exercises like the "Single Leg Stretch" and "Roll-Up" target the abdominal muscles, which are crucial for maintaining stability. Additionally, "Leg Circles" and "Side Planks" help strengthen hip abductors and stabilizers, contributing to better postural alignment and reducing the likelihood of falls. By regularly incorporating Pilates into a fitness routine, individuals can build strength and confidence, ultimately helping to prevent falls and maintain independence. |
| gyrotonic expansion exercise | Experimental | Other: gyrotonic expansion exerciseExercise phase Training Time Warm-Up Gentle, dynamic stretches focusing on the spine, hips, and legs. Gently roll the head from side to side to release tension, Move shoulders in a circular motion to loosen muscles, While standing, rotate the torso gently from side to side, Rotate each ankle in both directions to improve mobility. 5 minutes Core Activation Using pulley rope system the Arch and Curl, to engage the abdominal muscles, Focus on maintaining proper alignment and breathing deeply. 13 minutes Balance and Coordination Using pulley rope system Standing Series, shifting weight, such as the Spiral Sequence, to improve coordination. 12 minutes Flexibility and Range of Motion Leg stretches using the Leg Extension Unit to improve hip and knee range of motion. 5 minutes |
| control | No intervention | –No traninig |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18-65 years
- Diagnosed with CIPN
- Completed at least 3 cycles of chemotherapy
- Ability to provide informed consent
Key exclusion criteria (3 listed)
- Severe neuropathy requiring pharmacological intervention
- Concurrent participation in another physical therapy regimen
- Any medical condition contraindicating physical exercise.
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 |
|---|---|---|
| pilatesPilates exercises, particularly those focusing on core stability, balance, and flexibility, are highly beneficial for individuals at risk of falls. These exercises enhance proprioception, which is the body's ability to sense movement, action, and location, thereby improving coordination and balance. For example, exercises like the "Single Leg Stretch" and "Roll-Up" target the abdominal muscles, which are crucial for maintaining stability. Additionally, "Leg Circles" and "Side Planks" help strengthen hip abductors and stabilizers, contributing to better postural alignment and reducing the likelihood of falls. By regularly incorporating Pilates into a fitness routine, individuals can build strength and confidence, ultimately helping to prevent falls and maintain independence. | Other | (Pilates exercise |
| gyrotonic expansion exerciseExercise phase Training Time Warm-Up Gentle, dynamic stretches focusing on the spine, hips, and legs. Gently roll the head from side to side to release tension, Move shoulders in a circular motion to loosen muscles, While standing, rotate the torso gently from side to side, Rotate each ankle in both directions to improve mobility. 5 minutes Core Activation Using pulley rope system the Arch and Curl, to engage the abdominal muscles, Focus on maintaining proper alignment and breathing deeply. 13 minutes Balance and Coordination Using pulley rope system Standing Series, shifting weight, such as the Spiral Sequence, to improve coordination. 12 minutes Flexibility and Range of Motion Leg stretches using the Leg Extension Unit to improve hip and knee range of motion. 5 minutes | Other | gyrotonic expansion exercise |
Primary outcome
Chemotherapy Induced Peripheral Neuropathy Assessment Tool
Time frame: at baseline and at 12 weeks
The CIPNAT is a fifty item instrument that contains two sets of items symptom experience items and interference items. The 36 symptom experience items measure severity, distress, and frequency of nine neuropathic symptoms including; numbness in the hands, numbness in the feet, tingling in the hands, tingling in the feet, sensitivity to cold temperatures, nerve pain, muscle/joint aches, muscle weakness and loss of balance. Participants are first asked whether they have developed any of the nine symptoms since receiving chemotherapy. For each symptom reported, participants are asked to rate the intensity, distress, and frequency of that symptom on a 0-10 numeric rating scale. The symptom experience item set is scored by adding the number of symptoms reported (0-9) with the severity, distress, and frequency scores for each reported symptom. Scores range from 0-279 with higher scores corresponding with higher levels of CIPN.
3 secondary outcomes
Grip Strength
Time frame: at baseline and at 12 weeks
Dynamic Balance
Time frame: at baseline and at 12 weeks
Dual Task (DT) Gait Speed
Time frame: at baseline and at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pilates and gyrotonic expansion exercise in people with Neuropathy, run by MTI University 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 3 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemotherapy Induced Peripheral Neuropathy Assessment Tool (time frame: at baseline and at 12 weeks). 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 3 Mar 2026.