Diabetic NeuropathyNCT07394504
Effects of Turning Based Dual Task Training on Balance and Mild Cognitive Impairment in Diabetic Peripheral Neuropathy
A study testing Turning Based Dual Task Training and Dual-Task Training in people with Diabetic Neuropathy and Balance, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Diabetic Peripheral Neuropathy (DPN) is a common complication of diabetes, characterized by impaired sensory and motor function, often leading to balance dysfunction and an increased risk of falls. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Diabetic Neuropathy, Balance, Cognitive Dysfunction
- What is being tested?
- Turning Based Dual Task Training and Dual-Task Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Nov 2025to 5 May 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes Mellitus ≥ 5 years
- Diagnosed with Diabetic Peripheral Neuropathy
- Age 50 and above
- Berg Balance Scale (BBS 21-40) score
- Mild Cognitive Impairments (MoCA 18-25)
- Able to stand and walk with or without assistive devices
Who cannot join
- Severe neuropathic foot ulcers or Charcot joints.
- History of major musculoskeletal injuries affecting ambulation (Fractures of lower limb), Severe Osteoarthritis.
- Uncontrolled Diabetes.
- Neurological disorders unrelated to DPN (brain tumors, stroke, epilepsy, Alzheimer's, GBS and Parkinson's disease).
- Significant visual, auditory impairment.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Physical Therapy
Islamabad, 44000
About this study
Diabetic Peripheral Neuropathy (DPN) is a common complication of diabetes, characterized by impaired sensory and motor function, often leading to balance dysfunction and an increased risk of falls. Additionally, individuals with DPN are at heightened risk for mild cognitive impairment (MCI), which further compromises functional independence. This study aims to determine the effects of turning-based dual-task training compared to conventional dual-task training on balance, cognitive function, and fall risk in individuals with DPN. Pre- and post-intervention assessments will be conducted using the Berg Balance Scale (BBS), Montreal Cognitive Assessment (MoCA), and Timed Up and Go Test (TUGT) to evaluate balance, cognition, and fall risk respectively.
Read the detailed description
Diabetes mellitus (DM) is a chronic metabolic disorder characterized by hyperglycemia resulting from defects in insulin secretion, insulin action or both. As a major global health concern, its prevalence has been steadily increasing. According to the recent searches, 26.7% of adults in Pakistan are affected by diabetes. Implicated poor glycemic control, duration of diabetes, hyperlipidemia (particularly hypertriglyceridemia), elevated albumin excretion rates and obesity as risk factors for the development of DPN. This study aims to explore the effectiveness of these interventions in this specific population and to tell a treatment that will target both balance and cognition that will be used for DPN patients to improve the symptoms.
A randomized controlled trial will be conducted over one year. 44 participants will be selected through non- probability purposive sampling and randomly divided into two groups. The intervention will last eight weeks, comprising 24 treatment sessions. Assessments will be conducted at baseline and at the end of eight week. Treatment for Group A will include warm up, conventional balance training, turning based dual task training followed by cool down. Group B will include warm up, conventional balance training, dual task training followed by cool down.
- Conditions
- Diabetic Neuropathy, Balance, Cognitive Dysfunction, Cognitive Decline
- Being tested
- Turning Based Dual Task Training, Dual-Task Training
- Keywords
- Dual-task training, Dual-task Exercises
- Medical subject headings
- Diabetic Neuropathies, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turning Based Dual Task TrainingProcedure or surgery
Intervention will be of 8 weeks , 24 sessions, three per week, lasting 30-40 minutes. Warm-up exercises followed by cool down.
Conventional balance training consisting sitting eyes open/closed, dynamic weight shifting, Static/tandem Standing.
Turning protocol will be in three progressive phases. Phase 1 will include turning around cone, obstacles, during walking and 8 figure walk with cognitive dual task( name animals, shapes etc). Phase 2 exercises are 360 turn, sudden turn, stepping with turn, 8 figure turn and obstacle turn with more cognitive load. Phase 3 exercises are all exercises above in tandem walk with reaching activites and more cognitive load.
Dual-Task TrainingProcedure or surgery
Intervention will be of 8 weeks , 24 sessions, three per week, lasting 30-40 minutes. Warm-up exercises followed by cool down.
Conventional balance training consisting sitting eyes open/closed, dynamic weight shifting, Static/tandem Standing.
This protocol will be in three progressive phases. Phase 1 will include sit to stand, dynamic weight shifting (standing), stepping, walking in multi direction with cognitive task like name countries, sentence completion etc. Phase 2 will include additional step over low obstacle in walking along the above exercises with more repetitions and increased cognitive load.
Phase 3 will include tandem walk, step over high obstacle, ball throw/catch, multi direction walk in tandem with more increased cognitive load respectively.
| Study group | Role | What they receive |
|---|---|---|
| Turning Based Dual-Task Training | Experimental | Group A receives Turning Based Dual-Task Training:
The intervention will be conducted over a total duration of 8 weeks with total of 24 sessions 3 days per week lasting for 30 to 40 minutes. Warm up, Conventional balance training and cool down. Receives: Procedure: Turning Based Dual Task Training |
| Dual-Task Training | Experimental | Group B receives Dual-Task Training:
The intervention will be conducted over a total duration of 8 weeks with total of 24 sessions 3 days per week lasting for 30 to 40 minutes. Warm up, Conventional balance training and cool down. Receives: Procedure: Dual-Task Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Balance is assessed by Berg Balance Scale. Interpretations: mild=41-56,moderate=21-40,severe=0-20
Measured: 8 weeks
Cognition
MoCA will be used for mild cognitive impairment. Interpretations: Mild= 18-25, Moderate=10-17, Severe=0-9
Measured: 8 weeks
Fall Risk
Timed up and go test will be used for Fall Risk. Interpretations: Low Risk: <10 seconds, Moderate Risk: 10-19 seconds, High Risk: ≥ 14-20 seconds, Severe Risk: > 30 seconds
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start20 Nov 2025
- Primary completion10 Mar 2026
- Study completion5 May 2026
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.
- More trials run by Foundation University IslamabadThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394504
- Sponsor's protocol ID
- FUI/CTR/2025/29
- Status last verified
- May 2026
- First submitted
- 30 Jan 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Turning Based Dual Task Training on Balance and Mild Cognitive Impairment in Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07394504
- Acronym / sponsor ID
- FUI/CTR/2025/29
- Conditions
- Diabetic Neuropathy, Balance, Cognitive Dysfunction, Cognitive Decline
- Keywords
- Dual-task training, Dual-task Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 6 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, characterized by impaired sensory and motor function, often leading to balance dysfunction and an increased risk of falls. Additionally, individuals with DPN are at heightened risk for mild cognitive impairment (MCI), which further compromises functional independence. This study aims to determine the effects of turning-based dual-task training compared to conventional dual-task training on balance, cognitive function, and fall risk in individuals with DPN. Pre- and post-intervention assessments will be conducted using the Berg Balance Scale (BBS), Montreal Cognitive Assessment (MoCA), and Timed Up and Go Test (TUGT) to evaluate balance, cognition, and fall risk respectively.
Detailed description
Diabetes mellitus (DM) is a chronic metabolic disorder characterized by hyperglycemia resulting from defects in insulin secretion, insulin action or both. As a major global health concern, its prevalence has been steadily increasing. According to the recent searches, 26.7% of adults in Pakistan are affected by diabetes. Implicated poor glycemic control, duration of diabetes, hyperlipidemia (particularly hypertriglyceridemia), elevated albumin excretion rates and obesity as risk factors for the development of DPN. This study aims to explore the effectiveness of these interventions in this specific population and to tell a treatment that will target both balance and cognition that will be used for DPN patients to improve the symptoms.
A randomized controlled trial will be conducted over one year. 44 participants will be selected through non- probability purposive sampling and randomly divided into two groups. The intervention will last eight weeks, comprising 24 treatment sessions. Assessments will be conducted at baseline and at the end of eight week. Treatment for Group A will include warm up, conventional balance training, turning based dual task training followed by cool down. Group B will include warm up, conventional balance training, dual task training followed by cool down.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Turning Based Dual-Task Training | Experimental | Procedure: Turning Based Dual Task TrainingGroup A receives Turning Based Dual-Task Training: The intervention will be conducted over a total duration of 8 weeks with total of 24 sessions 3 days per week lasting for 30 to 40 minutes. Warm up, Conventional balance training and cool down. |
| Dual-Task Training | Experimental | Procedure: Dual-Task TrainingGroup B receives Dual-Task Training: The intervention will be conducted over a total duration of 8 weeks with total of 24 sessions 3 days per week lasting for 30 to 40 minutes. Warm up, Conventional balance training and cool down. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 Diabetes Mellitus ≥ 5 years
- Diagnosed with Diabetic Peripheral Neuropathy
- Age 50 and above
- Berg Balance Scale (BBS 21-40) score
- Mild Cognitive Impairments (MoCA 18-25)
Key exclusion criteria (5 listed)
- Severe neuropathic foot ulcers or Charcot joints.
- History of major musculoskeletal injuries affecting ambulation (Fractures of lower limb), Severe Osteoarthritis.
- Uncontrolled Diabetes.
- Neurological disorders unrelated to DPN (brain tumors, stroke, epilepsy, Alzheimer's, GBS and Parkinson's disease).
- Significant visual, auditory impairment.
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 |
|---|---|---|
| Turning Based Dual Task TrainingIntervention will be of 8 weeks , 24 sessions, three per week, lasting 30-40 minutes. Warm-up exercises followed by cool down. Conventional balance training consisting sitting eyes open/closed, dynamic weight shifting, Static/tandem Standing. Turning protocol will be in three progressive phases. Phase 1 will include turning around cone, obstacles, during walking and 8 figure walk with cognitive dual task( name animals, shapes etc). Phase 2 exercises are 360 turn, sudden turn, stepping with turn, 8 figure turn and obstacle turn with more cognitive load. Phase 3 exercises are all exercises above in tandem walk with reaching activites and more cognitive load. | Procedure or surgery | Turning Based Dual-Task Training |
| Dual-Task TrainingIntervention will be of 8 weeks , 24 sessions, three per week, lasting 30-40 minutes. Warm-up exercises followed by cool down. Conventional balance training consisting sitting eyes open/closed, dynamic weight shifting, Static/tandem Standing. This protocol will be in three progressive phases. Phase 1 will include sit to stand, dynamic weight shifting (standing), stepping, walking in multi direction with cognitive task like name countries, sentence completion etc. Phase 2 will include additional step over low obstacle in walking along the above exercises with more repetitions and increased cognitive load. Phase 3 will include tandem walk, step over high obstacle, ball throw/catch, multi direction walk in tandem with more increased cognitive load respectively. | Procedure or surgery | Dual-Task Training |
Primary outcome
Balance
Time frame: 8 weeks
Balance is assessed by Berg Balance Scale. Interpretations: mild=41-56,moderate=21-40,severe=0-20
Cognition
Time frame: 8 weeks
MoCA will be used for mild cognitive impairment. Interpretations: Mild= 18-25, Moderate=10-17, Severe=0-9
Fall Risk
Time frame: 8 weeks
Timed up and go test will be used for Fall Risk. Interpretations: Low Risk: <10 seconds, Moderate Risk: 10-19 seconds, High Risk: ≥ 14-20 seconds, Severe Risk: > 30 seconds
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 14 May 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.
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 Turning Based Dual Task Training and Dual-Task Training in people with Diabetic Neuropathy and Balance, run by Foundation University Islamabad 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 6 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: finished, as of the sponsor's last update on 14 May 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 (time frame: 8 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 14 May 2026.