Diabetic Peripheral NeuropathyPNF-SR in DPNNCT07380880
Comparison of Proprioceptive Neuromuscular Training and Sensory Re-education in Patients With Diabetic Peripheral Neuropathy
A study testing Sensory Re-Education Program and Proprioceptive Neuromuscular Training in people with Diabetic Peripheral Neuropathy, run by Montiha Azeem at 1 site in Pakistan.
Trial summary
Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus and is associated with sensory loss, impaired proprioception, balance deficits, and altered gait patterns, which significantly increase the risk of falls and functional dependence. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Sensory Re-Education Program and Proprioceptive Neuromuscular Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Feb 2026to 31 Mar 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both males and females Diagnosed with Diabetes Mellitus (Type 1 or Type 2) Aged between 40-75 years Presence of diabetic peripheral neuropathy (as confirmed by Michigan Neuropathy Assessment Tool or Toronto Clinical Rating Scale) HbA1c level > 7% consistently over the last 6 months
Who cannot join
- Unable to ambulate independently or with assistance Any history of neurological disorders Any history of musculoskeletal disordersin the past 6 months Renal and liver failure History of Ischemic heart disease History of dizziness or balance-impairing conditions
Trial locations and contacts
1 site in 1 country.
About this study
Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus and is associated with sensory loss, impaired proprioception, balance deficits, and altered gait patterns, which significantly increase the risk of falls and functional dependence. Rehabilitation strategies targeting sensory and proprioceptive impairments are essential to improve postural control and mobility in this population.
This randomized controlled trial aims to compare the effects of proprioceptive neuromuscular training and sensory re-education on balance and gait performance in patients with diabetic peripheral neuropathy. Participants diagnosed with DPN will be randomly allocated into two groups. Group A will receive sensory re-education, while Group B will undergo a structured proprioceptive training program. Both groups will also receive baseline conventional treatment.
Balance and gait outcomes will be assessed using the Berg Balance Scale and the Dynamic Gait Index at baseline, mid-intervention, and post-intervention. The findings of this study may help determine the more effective rehabilitation approach for improving balance and gait in individuals with diabetic peripheral neuropathy, thereby reducing fall risk and enhancing functional independence.
Read the detailed description
Diabetic peripheral neuropathy is a progressive complication of diabetes characterized by sensory impairment, proprioceptive deficits, and neuromuscular dysfunction. These impairments adversely affect balance control and gait stability, increasing the likelihood of falls, injuries, and reduced quality of life. Despite the widespread use of rehabilitation interventions, there is limited comparative evidence regarding the effectiveness of sensory re-education versus proprioceptive neuromuscular training in improving functional outcomes among individuals with DPN.
This randomized controlled trial will be conducted at the University Institute of Physical Therapy, Lahore, following approval from the Institute Research Ethics Board. Eligible participants with confirmed diabetic peripheral neuropathy will be recruited through referrals from endocrinologists and diabetologists. After obtaining informed consent, participants will be randomly assigned to either the sensory re-education group or the proprioceptive training group using a lottery method. The study will follow a single-blinded design, with outcome assessors blinded to group allocation.
Both groups will undergo a six-week intervention program consisting of three supervised sessions per week. Balance and gait performance will be evaluated at baseline, at the third week, and at the completion of the intervention using standardized outcome measures. Data analysis will focus on comparing within-group and between-group changes over time.
The results of this study are expected to provide evidence-based guidance for physical therapists in selecting effective rehabilitation strategies to improve balance and gait in patients with diabetic peripheral neuropathy, ultimately aiming to reduce fall risk and enhance functional mobility.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Sensory Re-Education Program, Proprioceptive Neuromuscular Training
- Keywords
- Proprioceptive Neuromuscular Training, Sensory Re-education, Balance, Gait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory Re-Education ProgramBehavioural
Participants will undergo a six-week sensory re-education program, three sessions per week. Each session includes:
Electrical Muscle Stimulation (EMS): 10 minutes applied to lower lumbar region and area of neuropathic discomfort (pulse width 100-200 µs, frequency 80-100 Hz, intensity as tolerated).
Sensory Re-Education: Stroking the affected skin using brushes and textured materials (rough hessian, wool, satin, cotton, fur) for 5 minutes per session, progressing from coarse to soft textures.
Balance and gait will be assessed using the Berg Balance Scale (BBS) and Dynamic Gait Index (DGI) at baseline, mid-intervention (3 weeks), and post-intervention (6 weeks).
Proprioceptive Neuromuscular TrainingBehavioural
Participants will receive a structured proprioceptive neuromuscular training program for six weeks, three sessions per week. Each session begins with 10 minutes of electrical muscle stimulation (EMS) applied to the lower lumbar region and area of neuropathic discomfort (pulse width 100-200 µs, frequency 80-100 Hz, intensity as tolerated). The main intervention consists of:
Balance exercises: bilateral stance, heel raises, single-leg stance with opposite hip flexed, performed with eyes open and closed.
Strengthening exercises: targeting lower limb muscles including quadriceps, hamstrings, and lateral thigh using squats and resistance exercises.
Plyometric exercises: single- and double-leg jumps with 90° and 180° rotations to enhance coordination.
Agility drills: figure-eight running and directional movements (forward, backward, lateral) along straight and spiral paths.
Each session lasts approximately 30 minutes, with progressive intensity and complexity based on individual toleran
| Study group | Role | What they receive |
|---|---|---|
| group A Sensory Re-Education | Experimental | Participants in this group will receive a structured sensory re-education program for six weeks, with three sessions per week. Each session will include 10 minutes of electrical muscle stimulation (EMS) applied to the lower lumbar region and area of neuropathic discomfort. Sensory re-education will involve stroking the affected skin using brushes and various textured materials, progressing from rough to soft textures over five minutes per session. Balance and gait will be assessed using the Berg Balance Scale (BBS) and Dynamic Gait Index (DGI) at baseline, mid-intervention, and post-intervention. Receives: Behavioral: Sensory Re-Education Program |
| group B Proprioceptive Neuromuscular Training | Active comparator | Participants in this group will undergo a structured proprioceptive neuromuscular training program for six weeks, with three sessions per week. Each session will start with 10 minutes of electrical muscle stimulation (EMS) applied to the lower lumbar region and area of neuropathic discomfort. The main intervention will include balance exercises (bilateral stance, heel raises, single-leg stance with hip flexion, eyes open and closed), strengthening exercises targeting lower limb muscles (quadriceps, hamstrings, lateral thigh), plyometric exercises (single- and double-leg jumps with rotations), and agility drills (figure-eight and directional movements). Each session lasts approximately 30 minutes, and exercises will progress in intensity and complexity based on participant tolerance. Balance and gait outcomes will be measured using the Berg Balance Scale (BBS) and Dynamic Gait Index (DGI) at baseline, mid-intervention, and post-intervention. Receives: Behavioral: Proprioceptive Neuromuscular Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Performance Assessed by the Berg Balance Scale
The primary outcome is the change in balance performance in patients with diabetic peripheral neuropathy. Balance will be measured using the Berg Balance Scale (BBS), a validated tool consisting of 14 tasks evaluating both static and dynamic balance, scored from 0 (lowest function) to 4 (best performance), with a total maximum score of 56. Higher scores indicate better balance and mobility. Assessments will be conducted at baseline, at 3 weeks, and at 6 weeks post-intervention.
Measured: Baseline, 3 weeks, and 6 weeks after the start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start10 Feb 2026
- Primary completion30 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral 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
- Model Description
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montiha Azeem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Montiha Azeem, University of Lahore
- Investigators
- Nimra Zaheer, MSPTN, Principal investigator, The University of Lahore, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380880
- Sponsor's protocol ID
- UOL/IREB/25/15/03/29
- Acronym
- PNF-SR in DPN
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Proprioceptive Neuromuscular Training and Sensory Re-education in Patients With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07380880
- Acronym / sponsor ID
- PNF-SR in DPN / UOL/IREB/25/15/03/29
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- Proprioceptive Neuromuscular Training, Sensory Re-education, Balance, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Montiha AzeemUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 2 Feb 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.
Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus and is associated with sensory loss, impaired proprioception, balance deficits, and altered gait patterns, which significantly increase the risk of falls and functional dependence. Rehabilitation strategies targeting sensory and proprioceptive impairments are essential to improve postural control and mobility in this population.
This randomized controlled trial aims to compare the effects of proprioceptive neuromuscular training and sensory re-education on balance and gait performance in patients with diabetic peripheral neuropathy. Participants diagnosed with DPN will be randomly allocated into two groups. Group A will receive sensory re-education, while Group B will undergo a structured proprioceptive training program. Both groups will also receive baseline conventional treatment.
Balance and gait outcomes will be assessed using the Berg Balance Scale and the Dynamic Gait Index at baseline, mid-intervention, and post-intervention. The findings of this study may help determine the more effective rehabilitation approach for improving balance and gait in individuals with diabetic peripheral neuropathy, thereby reducing fall risk and enhancing functional independence.
Detailed description
Diabetic peripheral neuropathy is a progressive complication of diabetes characterized by sensory impairment, proprioceptive deficits, and neuromuscular dysfunction. These impairments adversely affect balance control and gait stability, increasing the likelihood of falls, injuries, and reduced quality of life. Despite the widespread use of rehabilitation interventions, there is limited comparative evidence regarding the effectiveness of sensory re-education versus proprioceptive neuromuscular training in improving functional outcomes among individuals with DPN.
This randomized controlled trial will be conducted at the University Institute of Physical Therapy, Lahore, following approval from the Institute Research Ethics Board. Eligible participants with confirmed diabetic peripheral neuropathy will be recruited through referrals from endocrinologists and diabetologists. After obtaining informed consent, participants will be randomly assigned to either the sensory re-education group or the proprioceptive training group using a lottery method. The study will follow a single-blinded design, with outcome assessors blinded to group allocation.
Both groups will undergo a six-week intervention program consisting of three supervised sessions per week. Balance and gait performance will be evaluated at baseline, at the third week, and at the completion of the intervention using standardized outcome measures. Data analysis will focus on comparing within-group and between-group changes over time.
The results of this study are expected to provide evidence-based guidance for physical therapists in selecting effective rehabilitation strategies to improve balance and gait in patients with diabetic peripheral neuropathy, ultimately aiming to reduce fall risk and enhance functional mobility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| group A Sensory Re-Education | Experimental | Behavioral: Sensory Re-Education ProgramParticipants in this group will receive a structured sensory re-education program for six weeks, with three sessions per week. Each session will include 10 minutes of electrical muscle stimulation (EMS) applied to the lower lumbar region and area of neuropathic discomfort. Sensory re-education will involve stroking the affected skin using brushes and various textured materials, progressing from rough to soft textures over five minutes per session. Balance and gait will be assessed using the Berg Balance Scale (BBS) and Dynamic Gait Index (DGI) at baseline, mid-intervention, and post-intervention. |
| group B Proprioceptive Neuromuscular Training | Active comparator | Behavioral: Proprioceptive Neuromuscular TrainingParticipants in this group will undergo a structured proprioceptive neuromuscular training program for six weeks, with three sessions per week. Each session will start with 10 minutes of electrical muscle stimulation (EMS) applied to the lower lumbar region and area of neuropathic discomfort. The main intervention will include balance exercises (bilateral stance, heel raises, single-leg stance with hip flexion, eyes open and closed), strengthening exercises targeting lower limb muscles (quadriceps, hamstrings, lateral thigh), plyometric exercises (single- and double-leg jumps with rotations), and agility drills (figure-eight and directional movements). Each session lasts approximately 30 minutes, and exercises will progress in intensity and complexity based on participant tolerance. Balance and gait outcomes will be measured using the Berg Balance Scale (BBS) and Dynamic Gait Index (DGI) at baseline, mid-intervention, and post-intervention. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Both males and females Diagnosed with Diabetes Mellitus (Type 1 or Type 2) Aged between 40-75 years Presence of diabetic peripheral neuropathy (as confirmed by Michigan Neuropathy Assessment Tool or Toronto Clinical Rating Scale) HbA1c level > 7% consistently over the last 6 months
Key exclusion criteria (1 listed)
- Unable to ambulate independently or with assistance Any history of neurological disorders Any history of musculoskeletal disordersin the past 6 months Renal and liver failure History of Ischemic heart disease History of dizziness or balance-impairing conditions
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 |
|---|---|---|
| Sensory Re-Education ProgramParticipants will undergo a six-week sensory re-education program, three sessions per week. Each session includes: Electrical Muscle Stimulation (EMS): 10 minutes applied to lower lumbar region and area of neuropathic discomfort (pulse width 100-200 µs, frequency 80-100 Hz, intensity as tolerated). Sensory Re-Education: Stroking the affected skin using brushes and textured materials (rough hessian, wool, satin, cotton, fur) for 5 minutes per session, progressing from coarse to soft textures. Balance and gait will be assessed using the Berg Balance Scale (BBS) and Dynamic Gait Index (DGI) at baseline, mid-intervention (3 weeks), and post-intervention (6 weeks). | Behavioural | group A Sensory Re-Education |
| Proprioceptive Neuromuscular TrainingParticipants will receive a structured proprioceptive neuromuscular training program for six weeks, three sessions per week. Each session begins with 10 minutes of electrical muscle stimulation (EMS) applied to the lower lumbar region and area of neuropathic discomfort (pulse width 100-200 µs, frequency 80-100 Hz, intensity as tolerated). The main intervention consists of: Balance exercises: bilateral stance, heel raises, single-leg stance with opposite hip flexed, performed with eyes open and closed. Strengthening exercises: targeting lower limb muscles including quadriceps, hamstrings, and lateral thigh using squats and resistance exercises. Plyometric exercises: single- and double-leg jumps with 90° and 180° rotations to enhance coordination. Agility drills: figure-eight running and directional movements (forward, backward, lateral) along straight and spiral paths. Each session lasts approximately 30 minutes, with progressive intensity and complexity based on individual toleran | Behavioural | group B Proprioceptive Neuromuscular Training |
Primary outcome
Balance Performance Assessed by the Berg Balance Scale
Time frame: Baseline, 3 weeks, and 6 weeks after the start of intervention
The primary outcome is the change in balance performance in patients with diabetic peripheral neuropathy. Balance will be measured using the Berg Balance Scale (BBS), a validated tool consisting of 14 tasks evaluating both static and dynamic balance, scored from 0 (lowest function) to 4 (best performance), with a total maximum score of 56. Higher scores indicate better balance and mobility. Assessments will be conducted at baseline, at 3 weeks, and at 6 weeks post-intervention.
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 6 Jul 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.
Nimra Zaheer, MSPTN principal investigator
The University of Lahore, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Re-Education Program and Proprioceptive Neuromuscular Training in people with Diabetic Peripheral Neuropathy, run by Montiha Azeem 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 1 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: finished, as of the sponsor's last update on 6 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?
Balance Performance Assessed by the Berg Balance Scale (time frame: Baseline, 3 weeks, and 6 weeks after the start of intervention). 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 6 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.