Balance Impairment in Peripheral Diabetic NeuropathyNCT07830173
" Effects of Task Oriented Training on Balance With or Without Textured Insoles in Patient With Peripheral Diabetic Neuropathy."
A study testing Task oriented balance training and task oriented training with textured insoles in people with Balance Impairment in Peripheral Diabetic Neuropathy, run by Superior University at 1 site in Pakistan.
Trial summary
Introduction Peripheral diabetic neuropathy (PDN) is a common complication of diabetes that can cause sensory impairment, poor balance, and increased risk of falls. Task-oriented balance training may improve functional balance, while textured insoles may provide additional sensory input from the feet. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Balance Impairment in Peripheral Diabetic Neuropathy
- What is being tested?
- Task oriented balance training and task oriented training with textured insoles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Aug 2026to 24 Oct 2026
- Phase
- Interventional
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female.
- Aged 30 to 75 . 3 -Pre-diagnosed diabetic peripheral neuropathy due to type 2 diabetes by physician.
- 4 -Able to walk independently. 5 -Willing to wear insoles
Who cannot join
- 1-Foot ulcers. 2 -Structured deformities in lower limb. 3-Use of medications that affecting balance. 4-Any neurological condition other than peripheral diabetic neuropathy. 5-Any musculoskeletal disorder that affects balance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Task Oriented Training on Balance With or Without Textured Insoles in Patient With Peripheral Diabetic Neuropathy."
Introduction Peripheral diabetic neuropathy (PDN) is a common complication of diabetes that can cause sensory impairment, poor balance, and increased risk of falls. Task-oriented balance training may improve functional balance, while textured insoles may provide additional sensory input from the feet. However, limited evidence is available regarding the combined effect of these interventions in patients with PDN.
Objective The objective of this study is to determine the effect of task-oriented balance training with and without textured insoles on balance, functional mobility, and foot pain in patients with peripheral diabetic neuropathy.
Read more
Methodology This randomized controlled trial will include 28 participants, randomly divided into Group A (n=14) and Group B (n=14). Group A will receive task-oriented balance training without textured insoles, while Group B will receive task-oriented balance training with textured insoles. The intervention will be provided for 4 weeks, 3 days per week.
Pre- and post-intervention assessments will be performed using the Berg Balance Scale (BBS), Timed Up and Go (TUG), and Visual Analog Scale (VAS). The Michigan Neuropathy Screening Instrument (MNSI) will be used as a screening tool.
Data will be analyzed using SPSS version 25. Descriptive statistics will include mean, standard deviation, frequencies, and percentages. Normality will be assessed using the Shapiro-Wilk test. Appropriate parametric or non-parametric tests will be used for within- and between-group comparisons.
- Being tested
- Task oriented balance training, task oriented training with textured insoles
- Keywords
- peripheral diabetic neuropathy, foot pain, balance impairment, functional outcomes, task oriented training, textured oinsoles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task oriented balance trainingBehavioural
Participants with peripheral diabetic neuropathy will receive a structured task-oriented balance training program designed to improve functional balance, postural control, and performance of balance-related daily activities.
Each participant was given 3-5 sessions of task-oriented training per week for 6 weeks, each session 30-40 minutes in duration.
Group A (Control Group - Task-Oriented Training Alone)
The exercises in the Group A were structured task-oriented training program which is as follows:
- Sit-to-Stand Training:
- Tandem Standing.
- Obstacle Walking.
- Step-Up and Step-Down Training.
- Weight-Shifting Training.
- Single-Leg Standing.
- Walking Training.
- Reaching Activities. Each participant was performing these exercises for three to five sessions per week for 6 weeks, with each session lasting between 30 and 40 minutes.
task oriented training with textured insolesOther
Participants in the experimental group will use textured insoles with raised nodules designed to provide additional plantar sensory stimulation during standing and functional activities. The textured insoles will be used in combination with the task-oriented balance training program.1. Sit-to-Stand Training:
- Tandem Standing. 3. Obstacle Walking. 4. Step-Up and Step-Down Training. 5. Weight-Shifting Training. 6. Single-Leg Standing. 7. Walking Training. 8. Reaching Activities.
| Study group | Role | What they receive |
|---|---|---|
| group A task oriented training | Active comparator | The exercises in the Group A were structured task-oriented training program which is as follows:
1. Sit-to-Stand Training:
2. Tandem Standing.
3. Obstacle Walking.
4. Step-Up and Step-Down Training.
5. Weight-Shifting Training.
6. Single-Leg Standing.
7. Walking Training.
8. Reaching Activities. Each participant was performing these exercises for three to five sessions per week for 6 weeks, with each session lasting between 30 and 40 minutes. Receives: Behavioral: Task oriented balance training |
| group B task oriented training with textured insoles | Experimental | The Group B participants received the same training program as Group A, which was task oriented, but under the same frequency, duration and supervision. Furthermore, the participants in the experimental group wore textured insoles in their normal shoes during the task-oriented training sessions. The rationale for the raised nodular texture was to provide sensory feedback, proprioceptive input, and postural control and balance performance improvements for individuals with peripheral diabetic neuropathy. Wearing insoles 6hours/day for 6days/week.
1. Sit-to-Stand Training:
2. Tandem Standing.
3. Obstacle Walking.
4. Step-Up and Step-Down Training.
5. Weight-Shifting Training.
6. Single-Leg Standing. Receives: Behavioral: Task oriented balance training; Other: task oriented training with textured insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
balance measured by the berg balance scale
Balance will be assessed using the Berg Balance Scale (BBS), a validated 14-item clinical tool used to evaluate functional balance and risk of falls. The scale assesses static and dynamic balance during functional tasks such as sitting, standing, transfers, turning, and reaching. Higher scores indicate better balance performance.
Measured: The balance assessment is done pre treatment on day 1 week 1 before 1st session and second assessment is done on 12th session after 4 weeks]
Secondary outcomes (1)
visual analogue scale to assess foot pain
It is numeric pain rating scale ranging from 0-10. Patient willrate his pain from 0-10 with O means no pain and 10 with severe pain
Measured: The pain assessment is done pre treatment on day 1 week 1 before 1st session and second assessment is done on12th session after 4 weeks]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start24 Aug 2026
- Primary completion24 Oct 2026 (estimated)
- Study completion24 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance Impairment in Peripheral 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Rashid, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830173
- Sponsor's protocol ID
- FAHS/REHAB/04/26/MS/RS-4086
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 23 Sep 2026
- 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Task Oriented Training on Balance With or Without Textured Insoles in Patient With Peripheral Diabetic Neuropathy."
- ClinicalTrials.gov ID
- NCT07830173
- Acronym / sponsor ID
- FAHS/REHAB/04/26/MS/RS-4086
- Keywords
- peripheral diabetic neuropathy, foot pain, balance impairment, functional outcomes, task oriented training, textured oinsoles
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 24 Aug 2026 (actual)
- Primary completion
- 24 Oct 2026 (estimated)
- Study completion
- 24 Oct 2026 (estimated)
- First posted
- 21 Sep 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.
Introduction Peripheral diabetic neuropathy (PDN) is a common complication of diabetes that can cause sensory impairment, poor balance, and increased risk of falls. Task-oriented balance training may improve functional balance, while textured insoles may provide additional sensory input from the feet. However, limited evidence is available regarding the combined effect of these interventions in patients with PDN.
Objective The objective of this study is to determine the effect of task-oriented balance training with and without textured insoles on balance, functional mobility, and foot pain in patients with peripheral diabetic neuropathy.
Methodology This randomized controlled trial will include 28 participants, randomly divided into Group A (n=14) and Group B (n=14). Group A will receive task-oriented balance training without textured insoles, while Group B will receive task-oriented balance training with textured insoles. The intervention will be provided for 4 weeks, 3 days per week.
Pre- and post-intervention assessments will be performed using the Berg Balance Scale (BBS), Timed Up and Go (TUG), and Visual Analog Scale (VAS). The Michigan Neuropathy Screening Instrument (MNSI) will be used as a screening tool.
Data will be analyzed using SPSS version 25. Descriptive statistics will include mean, standard deviation, frequencies, and percentages. Normality will be assessed using the Shapiro-Wilk test. Appropriate parametric or non-parametric tests will be used for within- and between-group comparisons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A task oriented training | Active comparator | Behavioral: Task oriented balance trainingThe exercises in the Group A were structured task-oriented training program which is as follows: 1. Sit-to-Stand Training: 2. Tandem Standing. 3. Obstacle Walking. 4. Step-Up and Step-Down Training. 5. Weight-Shifting Training. 6. Single-Leg Standing. 7. Walking Training. 8. Reaching Activities. Each participant was performing these exercises for three to five sessions per week for 6 weeks, with each session lasting between 30 and 40 minutes. |
| group B task oriented training with textured insoles | Experimental | Behavioral: Task oriented balance training, Other: task oriented training with textured insolesThe Group B participants received the same training program as Group A, which was task oriented, but under the same frequency, duration and supervision. Furthermore, the participants in the experimental group wore textured insoles in their normal shoes during the task-oriented training sessions. The rationale for the raised nodular texture was to provide sensory feedback, proprioceptive input, and postural control and balance performance improvements for individuals with peripheral diabetic neuropathy. Wearing insoles 6hours/day for 6days/week. 1. Sit-to-Stand Training: 2. Tandem Standing. 3. Obstacle Walking. 4. Step-Up and Step-Down Training. 5. Weight-Shifting Training. 6. Single-Leg Standing. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Both male and female.
- Aged 30 to 75 . 3 -Pre-diagnosed diabetic peripheral neuropathy due to type 2 diabetes by physician.
- 4 -Able to walk independently. 5 -Willing to wear insoles
Key exclusion criteria (1 listed)
- 1-Foot ulcers. 2 -Structured deformities in lower limb. 3-Use of medications that affecting balance. 4-Any neurological condition other than peripheral diabetic neuropathy. 5-Any musculoskeletal disorder that affects balance.
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 |
|---|---|---|
| Task oriented balance trainingParticipants with peripheral diabetic neuropathy will receive a structured task-oriented balance training program designed to improve functional balance, postural control, and performance of balance-related daily activities. Each participant was given 3-5 sessions of task-oriented training per week for 6 weeks, each session 30-40 minutes in duration. Group A (Control Group - Task-Oriented Training Alone) The exercises in the Group A were structured task-oriented training program which is as follows: 1. Sit-to-Stand Training: 2. Tandem Standing. 3. Obstacle Walking. 4. Step-Up and Step-Down Training. 5. Weight-Shifting Training. 6. Single-Leg Standing. 7. Walking Training. 8. Reaching Activities. Each participant was performing these exercises for three to five sessions per week for 6 weeks, with each session lasting between 30 and 40 minutes. | Behavioural | group A task oriented training, group B task oriented training with textured insoles |
| task oriented training with textured insolesParticipants in the experimental group will use textured insoles with raised nodules designed to provide additional plantar sensory stimulation during standing and functional activities. The textured insoles will be used in combination with the task-oriented balance training program.1. Sit-to-Stand Training: 2. Tandem Standing. 3. Obstacle Walking. 4. Step-Up and Step-Down Training. 5. Weight-Shifting Training. 6. Single-Leg Standing. 7. Walking Training. 8. Reaching Activities. | Other | group B task oriented training with textured insoles |
Primary outcome
balance measured by the berg balance scale
Time frame: The balance assessment is done pre treatment on day 1 week 1 before 1st session and second assessment is done on 12th session after 4 weeks]
Balance will be assessed using the Berg Balance Scale (BBS), a validated 14-item clinical tool used to evaluate functional balance and risk of falls. The scale assesses static and dynamic balance during functional tasks such as sitting, standing, transfers, turning, and reaching. Higher scores indicate better balance performance.
1 secondary outcome
visual analogue scale to assess foot pain
Time frame: The pain assessment is done pre treatment on day 1 week 1 before 1st session and second assessment is done on12th session after 4 weeks]
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 23 Sep 2026.
- Individual participant dataSharing planned: No
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 Task oriented balance training and task oriented training with textured insoles in people with Balance Impairment in Peripheral Diabetic Neuropathy, run by Superior University 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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 23 Sep 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?
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?
balance measured by the berg balance scale (time frame: The balance assessment is done pre treatment on day 1 week 1 before 1st session and second assessment is done on 12th session after 4 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 23 Sep 2026.