Diabetic PolyneuropathyPhase 1FeMNCT06904417
Effect of Feldenkrais Method in Enhancing Postural Control for Patients with Diabetic Polyneuropathy
A Phase 1 study testing The Feldenkrais-based intervention and conventional balance training program in people with Diabetic Polyneuropathy, run by Cairo University at 1 site in Egypt.
Trial summary
Background: Postural Control is a major complication of polyneuropathy, affecting patients suffering from diabetes mellitus. Purpose: To examine the effect of the Feldenkrais Method on dynamic balance, limits of stability and fear of falling in adults aged 45 to 60 years with diabetic polyneuropathy in the short and… Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Diabetic Polyneuropathy
- What is being tested?
- The Feldenkrais-based intervention and conventional balance training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2025to 30 Jun 2025
- Phase
- Phase 1
- 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals must have a diagnosis of Diabetic Polyneuropathy (DPN), confirmed by clinical examination and electrophysiological testing.
- Participants must have stable glycemic control for at least three months prior to enrollment.
- Individuals must be able to walk independently, with or without the use of an assistive device.
Who cannot join
- Individuals with severe visual or vestibular impairments are excluded from participation.
- Participants with significant musculoskeletal disorders affecting gait are not eligible.
- Individuals with severe cardiovascular or respiratory conditions are excluded.
- Participants with cognitive impairments that prevent active participation are not eligible.
- Individuals currently engaged in structured physical therapy or balance training programs are excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of the Feldenkrais Method on Enhancing Postural Control in Patients with Diabetic Polyneuropathy
Background: Postural Control is a major complication of polyneuropathy, affecting patients suffering from diabetes mellitus. Purpose: To examine the effect of the Feldenkrais Method on dynamic balance, limits of stability and fear of falling in adults aged 45 to 60 years with diabetic polyneuropathy in the short and mid-term. Methods: A single-blinded, parallel, multicentric randomized control trial was conducted in two health centers. Adults aged 45 to 60 years with diabetic polyneuropathy and a history of falls or dynamic balance dysfunction were recruited from hospital databases and randomly assigned to either the study or control group. The study group received 16 sessions of Feldenkrais-based sensorimotor training. Both groups received diabetic foot care instructions and traditional balance exercises. Outcomes were measured at 3 and 6-month follow-up intervals. Dynamic balance was assessed using the Timed Up and Go (TUG) Test, limits of stability using Biodex and fear of falling with the Falls Efficacy Scale (FES).
- Conditions
- Diabetic Polyneuropathy
- Being tested
- The Feldenkrais-based intervention, conventional balance training program
- Keywords
- Feldenkrais Method, Postural Control, Diabetic Polyneuropathy
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Feldenkrais-based interventionOther
The Feldenkrais-based intervention consisted of guided awareness exercises aimed at improving movement patterns, proprioception, and postural control. Sessions were conducted twice weekly for 12 weeks, with each session lasting approximately 45 minutes
conventional balance training programOther
a conventional balance training program consisting of static and dynamic balance exercises, gait training, and strength-building activities, matched for session frequency and duration
| Study group | Role | What they receive |
|---|---|---|
| The Feldenkrais-based intervention | Experimental | this group recieve The Feldenkrais-based intervention consisted of guided awareness exercises Receives: Other: The Feldenkrais-based intervention |
| a conventional balance training program | Active comparator | The control group participated in a conventional balance training program consisting of static and dynamic balance exercises, gait training, and strength-building activities, matched for session frequency and duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Balance
Assessed using the Timed Up and Go Test, which measures the time taken to stand from a seated position, walk three meters, turn around, walk back, and sit down.
Measured: From enrollment to the end of treatment at 12 weeks
Postural Control
Evaluated using the Biodex Balance System, which measures limits of stability and sway index
Measured: From enrollment to the end of treatment at 12 weeks
Fear of Falling
Assessed using the Falls Efficacy Scale, a self-reported measure of confidence in performing daily activities without falling.
Measured: From enrollment to the end of treatment 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 posted1 Apr 2025
- Study start30 Mar 2025 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PolyneuropathyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Feldenkrais-based intervention consisted of guided awareness exercises aimed at improving movement patterns, proprioception, and postural control. Sessions were conducted twice weekly for 12 weeks, with each session lasting approximately 45 minutes.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Hassan Fayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904417
- Sponsor's protocol ID
- P.T.REC/012/005646
- Acronym
- FeM
- Status last verified
- Dec 2024
- First submitted
- 5 Feb 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Feldenkrais Method on Enhancing Postural Control in Patients with Diabetic Polyneuropathy
- ClinicalTrials.gov ID
- NCT06904417
- Acronym / sponsor ID
- FeM / P.T.REC/012/005646
- Conditions
- Diabetic Polyneuropathy
- Keywords
- Feldenkrais Method, Postural Control, Diabetic Polyneuropathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Mar 2025 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 1 Apr 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.
Background: Postural Control is a major complication of polyneuropathy, affecting patients suffering from diabetes mellitus. Purpose: To examine the effect of the Feldenkrais Method on dynamic balance, limits of stability and fear of falling in adults aged 45 to 60 years with diabetic polyneuropathy in the short and mid-term. Methods: A single-blinded, parallel, multicentric randomized control trial was conducted in two health centers. Adults aged 45 to 60 years with diabetic polyneuropathy and a history of falls or dynamic balance dysfunction were recruited from hospital databases and randomly assigned to either the study or control group. The study group received 16 sessions of Feldenkrais-based sensorimotor training. Both groups received diabetic foot care instructions and traditional balance exercises. Outcomes were measured at 3 and 6-month follow-up intervals. Dynamic balance was assessed using the Timed Up and Go (TUG) Test, limits of stability using Biodex and fear of falling with the Falls Efficacy Scale (FES).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The Feldenkrais-based intervention consisted of guided awareness exercises aimed at improving movement patterns, proprioception, and postural control. Sessions were conducted twice weekly for 12 weeks, with each session lasting approximately 45 minutes.
| Arm | Type | Receives |
|---|---|---|
| The Feldenkrais-based intervention | Experimental | Other: The Feldenkrais-based interventionthis group recieve The Feldenkrais-based intervention consisted of guided awareness exercises |
| a conventional balance training program | Active comparator | –The control group participated in a conventional balance training program consisting of static and dynamic balance exercises, gait training, and strength-building activities, matched for session frequency and duration |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Individuals must have a diagnosis of Diabetic Polyneuropathy (DPN), confirmed by clinical examination and electrophysiological testing.
- Participants must have stable glycemic control for at least three months prior to enrollment.
- Individuals must be able to walk independently, with or without the use of an assistive device.
Key exclusion criteria (5 listed)
- Individuals with severe visual or vestibular impairments are excluded from participation.
- Participants with significant musculoskeletal disorders affecting gait are not eligible.
- Individuals with severe cardiovascular or respiratory conditions are excluded.
- Participants with cognitive impairments that prevent active participation are not eligible.
- Individuals currently engaged in structured physical therapy or balance training programs are excluded.
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 |
|---|---|---|
| The Feldenkrais-based interventionThe Feldenkrais-based intervention consisted of guided awareness exercises aimed at improving movement patterns, proprioception, and postural control. Sessions were conducted twice weekly for 12 weeks, with each session lasting approximately 45 minutes | Other | The Feldenkrais-based intervention |
| conventional balance training programa conventional balance training program consisting of static and dynamic balance exercises, gait training, and strength-building activities, matched for session frequency and duration | Other | – |
Primary outcome
Dynamic Balance
Time frame: From enrollment to the end of treatment at 12 weeks
Assessed using the Timed Up and Go Test, which measures the time taken to stand from a seated position, walk three meters, turn around, walk back, and sit down.
Postural Control
Time frame: From enrollment to the end of treatment at 12 weeks
Evaluated using the Biodex Balance System, which measures limits of stability and sway index
Fear of Falling
Time frame: From enrollment to the end of treatment at 12 weeks
Assessed using the Falls Efficacy Scale, a self-reported measure of confidence in performing daily activities without falling.
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 1 Apr 2025.
- Individual participant dataSharing planned: No
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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.
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 Phase 1 study testing The Feldenkrais-based intervention and conventional balance training program in people with Diabetic Polyneuropathy, run by Cairo 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 3 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 1 Apr 2025. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Dynamic Balance (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 3 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 1 Apr 2025.