Diabetic NeuropathyDNPNCT07712289
Comparative Analysis Between Textured Insoles and Roods Technique Affecting Balance in DNP.
A study testing Roods Facilitatory Technique and Textured Insoles in people with Diabetic Neuropathy and Diabetes, run by University of Faisalabad at 1 site in Pakistan.
Trial summary
The purpose of this randomized controlled trial is to compare the effectiveness of textured insoles versus Rood's facilitatory technique in improving balance in patients with diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Diabetic Neuropathy, Diabetes
- What is being tested?
- Roods Facilitatory Technique and Textured Insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Mar 2025to 26 May 2025
- 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must have a clinical diagnosis of Type 2 diabetes.
- Participants must show evidence of diabetic peripheral neuropathy (DPN) as diagnosed by clinical examination.
- Participants with 25-40 Berg Balance Score.
- Participants with 6-8(Patient version) and 2.5-4(Physical assessment) Michigan Neuropathy Score.
- Participants aged 45 years to 60.
- Participants taking medications.
- Participants must be able to understand the study procedures and provide written informed consent.
Who cannot join
- Participants who have significant cognitive impairments (e.g., dementia) that would prevent them from understanding and adhering to study instructions.
- Participants with severe PAD or significant circulatory problems that would contraindicate the use of insoles or tactile stimulation therapy.
- Participants with other neurological conditions that could confound the results.
- Participants who have had recent surgery or trauma to the feet or lower extremities in the past 6 months.
- Participants who are involved in another clinical trial.
- Participants with active diabetic foot ulcers, severe deformities, infections, or other complications that would make it unsafe or inappropriate to use textured insoles.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
The University of Faisalabad
Faisalābad, Punjab Province, 38000
About this study
Official title: Comparative Analysis Between Textured Insoles and Roods Facilitatory Technique Affecting Balance in Patients With Diabetic Neuropathy
The purpose of this randomized controlled trial is to compare the effectiveness of textured insoles versus Rood's facilitatory technique in improving balance in patients with diabetic neuropathy. The study aims to answer the following question: What is the comparative analysis between textured insoles and Rood's facilitatory techniques affecting balance in patient with diabetic neuropathy?
Participants assigned into two groups. Group A received contrast bath plus Rood's facilitatory techniques, while Group B received contrast bath plus textured insoles. Treatment will be delivered over a four-week period, with three sessions per week on alternative days.
- Conditions
- Diabetic Neuropathy, Diabetes
- Being tested
- Roods Facilitatory Technique, Textured Insoles
- Keywords
- Diabetes, diabetic neuropathy, insoles, textured insoles, roods technique, roods facilitatory technique
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roods Facilitatory TechniqueOther
Quick stretch and Heavy compression technique targeted areas of lower extremities
Textured InsolesDevice
Participants wore allocated insoles, in their own shoes, as much as possible.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A received contrast bath plus Rood's facilitatory techniques. Receives: Other: Roods Facilitatory Technique |
| Group B | Active comparator | Group B received contrast bath plus textured insoles. Receives: Device: Textured Insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
BBS
Berg Balance Scale
Measured: Four weeks
Secondary outcomes (1)
MNSI
Michigan Neuropathy Screening Instrument
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start4 Mar 2025
- Primary completion26 May 2025
- Study completion26 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic 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
- Parallel groups
- Model description
- Group A received contrast bath plus Rood's facilitatory techniques, while Group B received contrast bath plus textured insoles.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712289
- Sponsor's protocol ID
- TUF/IRB/96/2025
- Acronym
- DNP
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis Between Textured Insoles and Roods Facilitatory Technique Affecting Balance in Patients With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT07712289
- Acronym / sponsor ID
- DNP / TUF/IRB/96/2025
- Conditions
- Diabetic Neuropathy, Diabetes
- Keywords
- Diabetes, diabetic neuropathy, insoles, textured insoles, roods technique, roods facilitatory technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of FaisalabadUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 26 May 2025 (actual)
- Study completion
- 26 May 2025 (actual)
- First posted
- 17 Jul 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.
The purpose of this randomized controlled trial is to compare the effectiveness of textured insoles versus Rood's facilitatory technique in improving balance in patients with diabetic neuropathy. The study aims to answer the following question: What is the comparative analysis between textured insoles and Rood's facilitatory techniques affecting balance in patient with diabetic neuropathy?
Participants assigned into two groups. Group A received contrast bath plus Rood's facilitatory techniques, while Group B received contrast bath plus textured insoles. Treatment will be delivered over a four-week period, with three sessions per week on alternative days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group A received contrast bath plus Rood's facilitatory techniques, while Group B received contrast bath plus textured insoles.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Roods Facilitatory TechniqueGroup A received contrast bath plus Rood's facilitatory techniques. |
| Group B | Active comparator | Device: Textured InsolesGroup B received contrast bath plus textured insoles. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants must have a clinical diagnosis of Type 2 diabetes.
- Participants must show evidence of diabetic peripheral neuropathy (DPN) as diagnosed by clinical examination.
- Participants with 25-40 Berg Balance Score.
- Participants with 6-8(Patient version) and 2.5-4(Physical assessment) Michigan Neuropathy Score.
- Participants aged 45 years to 60.
Key exclusion criteria (6 listed)
- Participants who have significant cognitive impairments (e.g., dementia) that would prevent them from understanding and adhering to study instructions.
- Participants with severe PAD or significant circulatory problems that would contraindicate the use of insoles or tactile stimulation therapy.
- Participants with other neurological conditions that could confound the results.
- Participants who have had recent surgery or trauma to the feet or lower extremities in the past 6 months.
- Participants who are involved in another clinical trial.
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 |
|---|---|---|
| Roods Facilitatory TechniqueQuick stretch and Heavy compression technique targeted areas of lower extremities | Other | Group A |
| Textured InsolesParticipants wore allocated insoles, in their own shoes, as much as possible. | Device | Group B |
Primary outcome
BBS
Time frame: Four weeks
Berg Balance Scale
1 secondary outcome
MNSI
Time frame: Four 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 17 Jul 2026.
- 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. 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 Roods Facilitatory Technique and Textured Insoles in people with Diabetic Neuropathy and Diabetes, run by University of Faisalabad at 1 site in Pakistan.
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 7 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: finished, as of the sponsor's last update on 17 Jul 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 Pakistan. 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?
BBS (time frame: Four 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 17 Jul 2026.