Diabetic Pheripheral NeuropathyVAS-BBSNCT07909707
COMPARISON OF MULTISENSORY EXERCISE AND TIBIAL NERVE MOBILIZATION IN PATIENTS WITH TYPE 2 DIABETIC PERIPHERAL NEUROPATHY
A study testing Tibial nerve mobilization and Multisensory Excercise in people with Diabetic Pheripheral Neuropathy, run by Qurat Ul Ain Ashfaq at 1 site in Pakistan.
Trial summary
Diabetes mellitus is a chronic metabolic condition characterized by high blood glucose levels due to insufficient insulin production or the body's inability to respond properly to insulin. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Diabetic Pheripheral Neuropathy
- What is being tested?
- Tibial nerve mobilization and Multisensory Excercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Oct 2025to 28 Aug 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 60 years
- Women only
- No healthy volunteers
- Adult
Inclusion Criteria: Adults aged 40-60 years. Diagnosed cases of type 2 diabetes mellitus by clinical and laboratory tests. Diagnosed case of subclinical diabetic neuropathy by physician. Moderately disturbed balance on BBS from the 21 to 40 range. Both male and female participants. Participants must have poor glycemic control according to HbA1c ≥ 7.5% or fasting blood glucose ≥ 130 mg/dl or random blood glucose ≥ 200 mg/dl.
No cognitive impairments that would affect participation. (31) Diabetes duration of less than 10 years. Severe diabetic neuropathy with a <12 score on the Toronto Clinical Neuropathy Score.
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Exclusion Criteria: Presence of other systemic diseases apart from diabetes, such as autoimmune diseases or rheumatoid arthritis.
Foot ulcers that are classified as Grade 2 or higher using the Wagner Ulcer Classification.
Recent fractures, or trauma leading to nerve injuries in the last year. Patient with any other neurological issue like stroke, multiple sclerosis, Parkinson's, etc.
Visual impairments or cognitive disorders that could affect participation. History of recent vascular complications, surgical procedures for lower limbs in the last 6 months, or amputation above the metatarsophalangeal joint.
Leprosy or any skin disease.
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Trial locations and contacts
1 site in 1 country.
About this study
Diabetes mellitus is a chronic metabolic condition characterized by high blood glucose levels due to insufficient insulin production or the body's inability to respond properly to insulin. One of its common complications is diabetic peripheral neuropathy (DPN), which develops when prolonged high blood glucose levels damage peripheral nerves, particularly those in the lower limbs and feet. Patients with diabetic peripheral neuropathy may experience burning pain, tingling, numbness, muscle weakness, and loss of sensation. The condition can also affect balance and walking ability, making daily activities difficult. Reduced sensation increases the risk of unnoticed injuries, foot infections, ulcers, and other serious complications.
A randomized controlled trial was conducted involving 38 participants, divided into two groups. Group A received tibial nerve mobilization along with conventional physiotherapy, while Group B received multisensory exercise training along with conventional physiotherapy. According to the abstract, both interventions were delivered for 35 minutes per session, three sessions per week, over four weeks.
The aim of this study is to determine the comparison of multisensory exercise and tibial nerve mobilization in patients with type 2 diabetic peripheral neuropathy.
Read the detailed description
Diabetes mellitus is a chronic metabolic disorder characterized by elevated blood glucose levels due to insufficient insulin production or the body's reduced response to insulin. One of its important complications is diabetic peripheral neuropathy (DPN), which involves damage to peripheral nerves, particularly those supplying the lower limbs and feet. Patients with diabetic peripheral neuropathy may experience burning pain, tingling, numbness, muscle weakness, and reduced sensation. The condition can also impair balance and walking ability, increasing the risk of unnoticed injuries, foot ulcers, infections, and functional limitations. Chronic high blood glucose contributes to nerve damage through metabolic, vascular, oxidative stress, and inflammatory processes. These changes may impair nerve function and negatively affect patients' physical, mental, and overall quality of life. Physiotherapy can help address the functional problems associated with diabetic peripheral neuropathy. Two interventions considered in this study are multisensory exercise and tibial nerve mobilization.
Multisensory exercise focuses on activities that challenge sensory integration and postural control. Tibial nerve mobilization focuses on mobilizing the tibial nerve to address neural movement and sensitivity. The study compares these interventions to determine their relative merits. The BBS is a functional assessment tool used to evaluate balance during sitting, standing, and functional movements. It consists of 14 items, each scored on a five-point scale. The scores are added to obtain the overall balance score. A higher score indicates better balance performance. The SF-12 is a 12-item questionnaire used to assess health-related quality of life. Group A-Multisensory exercise: Participants receive multisensory exercise training alongside conventional physiotherapy.
Group B - Tibial nerve mobilization: Participants receive tibial nerve mobilization alongside conventional physiotherapy. Thirty five minutes per session, three sessions per week, for four weeks. Pain, balance, and quality of life are evaluated to compare the outcomes of the two interventions.
- Conditions
- Diabetic Pheripheral Neuropathy
- Being tested
- Tibial nerve mobilization, Multisensory Excercise
- Keywords
- Balance, Quality of life, Pain intensity
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tibial nerve mobilizationOther
Tibial nerve mobilization will be administered for 20 minutes as part of a 35-minute treatment session. The intervention included three techniques: remote sliders, local sliders, and tensioners. For remote sliders, the patient was positioned in supine lying with the hip flexed to approximately 90° and the knee extended. Ankle dorsiflexion with eversion was combined with cervical flexion and extension to facilitate proximal and distal neural excursion. For local sliders, the patient remained supine with the hip and cervical spine in neutral and the knee fully extended and stabilized. The therapist supported the heel and forefoot while alternating ankle dorsiflexion with eversion and plantarflexion with inversion. For tensioners, the patient lay supine with the hip flexed and knee fully extended; the therapist progressively elevated the limb to increase hip flexion while applying ankle dorsiflexion with eversion and simultaneous cervical flexion to increase neural tension.
Multisensory ExcerciseOther
Participants in the multisensory exercise group received multisensory exercise training in addition to conventional physiotherapy. The session duration was 35 minutes, 3 sessions per week, and for 4 weeks. Warm-up: ankle dorsiflexion and plantarflexion, inversion and eversion, walking at a normal pace, and calf and hamstring stretching.
Visual-system exercises: visual-motor coordination, including focusing on a moving target while moving the head from side to side and up and down. The intervention was intended to improve balance, functional performance, and quality of life, while reducing pain associated with diabetic peripheral neuropathy. In conventional treatment, TENS will apply for 5 minutes, with a pulse duration of 150 µs and a frequency of 80 Hz.
Ankle range-of-motion exercises: 5 minutes, including dorsiflexion, plantarflexion, inversion, and eversion, with 10 repetitions of the movements.
| Study group | Role | What they receive |
|---|---|---|
| Multisensory Excercise | Active comparator | Participants in the multisensory exercise group received multisensory exercise training in addition to conventional physiotherapy. The session duration was 35 minutes, 3 sessions per week, and for 4 weeks. Warm-up: ankle dorsiflexion and plantarflexion, inversion and eversion, walking at a normal pace, and calf and hamstring stretching. Visual-system exercises: visual-motor coordination, including focusing on a moving target while moving the head from side to side and up and down. The intervention was intended to improve balance, functional performance, and quality of life, while reducing pain associated with diabetic peripheral neuropathy. Receives: Other: Multisensory Excercise |
| Tibial nerve mobilization | Active comparator | Tibial nerve mobilization will be administered for 20 minutes as part of a 35-minute treatment session. The intervention included three techniques: remote sliders, local sliders, and tensioners. For remote sliders, the patient was positioned in supine lying with the hip flexed to approximately 90° and the knee extended. Ankle dorsiflexion with eversion was combined with cervical flexion and extension to facilitate proximal and distal neural excursion. For local sliders, the patient remained supine with the hip and cervical spine in neutral and the knee fully extended and stabilized. The therapist supported the heel and forefoot while alternating ankle dorsiflexion with eversion and plantarflexion with inversion. For tensioners, the patient lay supine with the hip flexed and knee fully extended; the therapist progressively elevated the limb to increase hip flexion while applying ankle dorsiflexion with eversion and simultaneous cervical flexion to increase neural tension. Receives: Other: Tibial nerve mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The scoring range is from 0 to 10, where 0 shows no pain, 5 shows moderate pain, and 10 shows the worst pain.
Measured: 4 weeks
Secondary outcomes (2)
Quality of life (SF-12 Health Survey)
It will be used to evaluate the quality of life. It is a health-related quality of life questionnaire including 12 questions. (28) It has eight main ones, which are some up to see physical and mental health. It has a scoring range from 0 to 100 for both physical and mental health.
Measured: 4 weeks
Berg Balance Scale (BBS)
The Berg balance scale consists of 14 dynamic and static activities that were applicable to everyday life. Through direct observation of the participant's performance by medical professionals in a variety of contexts, the BBS evaluates balance and fall risk. A 5-point ordinal scale was used for scoring, with 0 denoting incompetence to execute the job and 4 denoting independence. The best possible score of 56 indicates good balance.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start20 Oct 2025
- Primary completion27 Jul 2026
- Study completion28 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Pheripheral 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
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qurat Ul Ain Ashfaq
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qurat Ul Ain Ashfaq, Superior University
- Investigators
- Irum Hassan, MS Rehablitaion Sciences, Principal investigator, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909707
- Sponsor's protocol ID
- REHAB/04/26/MS/RS-4095
- Acronym
- VAS-BBS
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 2 Nov 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF MULTISENSORY EXERCISE AND TIBIAL NERVE MOBILIZATION IN PATIENTS WITH TYPE 2 DIABETIC PERIPHERAL NEUROPATHY
- ClinicalTrials.gov ID
- NCT07909707
- Acronym / sponsor ID
- VAS-BBS / REHAB/04/26/MS/RS-4095
- Conditions
- Diabetic Pheripheral Neuropathy
- Keywords
- Balance, Quality of life, Pain intensity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Qurat Ul Ain AshfaqUniversity, hospital or other
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 27 Jul 2026 (actual)
- Study completion
- 28 Aug 2026 (actual)
- First posted
- 2 Nov 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.
Diabetes mellitus is a chronic metabolic condition characterized by high blood glucose levels due to insufficient insulin production or the body's inability to respond properly to insulin. One of its common complications is diabetic peripheral neuropathy (DPN), which develops when prolonged high blood glucose levels damage peripheral nerves, particularly those in the lower limbs and feet. Patients with diabetic peripheral neuropathy may experience burning pain, tingling, numbness, muscle weakness, and loss of sensation. The condition can also affect balance and walking ability, making daily activities difficult. Reduced sensation increases the risk of unnoticed injuries, foot infections, ulcers, and other serious complications.
A randomized controlled trial was conducted involving 38 participants, divided into two groups. Group A received tibial nerve mobilization along with conventional physiotherapy, while Group B received multisensory exercise training along with conventional physiotherapy. According to the abstract, both interventions were delivered for 35 minutes per session, three sessions per week, over four weeks.
The aim of this study is to determine the comparison of multisensory exercise and tibial nerve mobilization in patients with type 2 diabetic peripheral neuropathy.
Detailed description
Diabetes mellitus is a chronic metabolic disorder characterized by elevated blood glucose levels due to insufficient insulin production or the body's reduced response to insulin. One of its important complications is diabetic peripheral neuropathy (DPN), which involves damage to peripheral nerves, particularly those supplying the lower limbs and feet. Patients with diabetic peripheral neuropathy may experience burning pain, tingling, numbness, muscle weakness, and reduced sensation. The condition can also impair balance and walking ability, increasing the risk of unnoticed injuries, foot ulcers, infections, and functional limitations. Chronic high blood glucose contributes to nerve damage through metabolic, vascular, oxidative stress, and inflammatory processes. These changes may impair nerve function and negatively affect patients' physical, mental, and overall quality of life. Physiotherapy can help address the functional problems associated with diabetic peripheral neuropathy. Two interventions considered in this study are multisensory exercise and tibial nerve mobilization.
Multisensory exercise focuses on activities that challenge sensory integration and postural control. Tibial nerve mobilization focuses on mobilizing the tibial nerve to address neural movement and sensitivity. The study compares these interventions to determine their relative merits. The BBS is a functional assessment tool used to evaluate balance during sitting, standing, and functional movements. It consists of 14 items, each scored on a five-point scale. The scores are added to obtain the overall balance score. A higher score indicates better balance performance. The SF-12 is a 12-item questionnaire used to assess health-related quality of life. Group A-Multisensory exercise: Participants receive multisensory exercise training alongside conventional physiotherapy.
Group B - Tibial nerve mobilization: Participants receive tibial nerve mobilization alongside conventional physiotherapy. Thirty five minutes per session, three sessions per week, for four weeks. Pain, balance, and quality of life are evaluated to compare the outcomes of the two interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multisensory Excercise | Active comparator | Other: Multisensory ExcerciseParticipants in the multisensory exercise group received multisensory exercise training in addition to conventional physiotherapy. The session duration was 35 minutes, 3 sessions per week, and for 4 weeks. Warm-up: ankle dorsiflexion and plantarflexion, inversion and eversion, walking at a normal pace, and calf and hamstring stretching. Visual-system exercises: visual-motor coordination, including focusing on a moving target while moving the head from side to side and up and down. The intervention was intended to improve balance, functional performance, and quality of life, while reducing pain associated with diabetic peripheral neuropathy. |
| Tibial nerve mobilization | Active comparator | Other: Tibial nerve mobilizationTibial nerve mobilization will be administered for 20 minutes as part of a 35-minute treatment session. The intervention included three techniques: remote sliders, local sliders, and tensioners. For remote sliders, the patient was positioned in supine lying with the hip flexed to approximately 90° and the knee extended. Ankle dorsiflexion with eversion was combined with cervical flexion and extension to facilitate proximal and distal neural excursion. For local sliders, the patient remained supine with the hip and cervical spine in neutral and the knee fully extended and stabilized. The therapist supported the heel and forefoot while alternating ankle dorsiflexion with eversion and plantarflexion with inversion. For tensioners, the patient lay supine with the hip flexed and knee fully extended; the therapist progressively elevated the limb to increase hip flexion while applying ankle dorsiflexion with eversion and simultaneous cervical flexion to increase neural tension. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Tibial nerve mobilizationTibial nerve mobilization will be administered for 20 minutes as part of a 35-minute treatment session. The intervention included three techniques: remote sliders, local sliders, and tensioners. For remote sliders, the patient was positioned in supine lying with the hip flexed to approximately 90° and the knee extended. Ankle dorsiflexion with eversion was combined with cervical flexion and extension to facilitate proximal and distal neural excursion. For local sliders, the patient remained supine with the hip and cervical spine in neutral and the knee fully extended and stabilized. The therapist supported the heel and forefoot while alternating ankle dorsiflexion with eversion and plantarflexion with inversion. For tensioners, the patient lay supine with the hip flexed and knee fully extended; the therapist progressively elevated the limb to increase hip flexion while applying ankle dorsiflexion with eversion and simultaneous cervical flexion to increase neural tension. | Other | Tibial nerve mobilization |
| Multisensory ExcerciseParticipants in the multisensory exercise group received multisensory exercise training in addition to conventional physiotherapy. The session duration was 35 minutes, 3 sessions per week, and for 4 weeks. Warm-up: ankle dorsiflexion and plantarflexion, inversion and eversion, walking at a normal pace, and calf and hamstring stretching. Visual-system exercises: visual-motor coordination, including focusing on a moving target while moving the head from side to side and up and down. The intervention was intended to improve balance, functional performance, and quality of life, while reducing pain associated with diabetic peripheral neuropathy. In conventional treatment, TENS will apply for 5 minutes, with a pulse duration of 150 µs and a frequency of 80 Hz. Ankle range-of-motion exercises: 5 minutes, including dorsiflexion, plantarflexion, inversion, and eversion, with 10 repetitions of the movements. | Other | Multisensory Excercise |
Primary outcome
Visual Analogue Scale
Time frame: 4 weeks
The scoring range is from 0 to 10, where 0 shows no pain, 5 shows moderate pain, and 10 shows the worst pain.
2 secondary outcomes
Quality of life (SF-12 Health Survey)
Time frame: 4 weeks
Berg Balance Scale (BBS)
Time frame: 4 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 2 Nov 2026.
- Related InfoLink provided by the sponsor.
- 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.
Irum Hassan, MS Rehablitaion Sciences principal investigator
Superior University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tibial nerve mobilization and Multisensory Excercise in people with Diabetic Pheripheral Neuropathy, run by Qurat Ul Ain Ashfaq 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?
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 2 Nov 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?
Visual Analogue Scale (time frame: 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 2 Nov 2026.