AzTrials
AzTrials

Diabetic NeuropathiesNCT07827417

Comparative Effects of Reactive Balance Training and Task-Oriented Training on Postural Stability in Patients With Diabetic Peripheral Neuropathy

A study testing Reactive Balance Training and TASK ORIENTED TRAINING in people with Diabetic Neuropathies and Rehabilitation, run by Foundation University Islamabad at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Diabetic peripheral neuropathy (DPN) is a common complication of prolonged hyperglycemia that damages peripheral nerves, leading to impaired sensory function, increased fall risk, and reduced quality of life. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Reactive Balance Training and TASK ORIENTED TRAINING
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 sitePakistan
Study dates
11 Feb 2026to 30 Jan 2027
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Both gender
  • Adults aged 40 years and above diagnosed with type 2 diabetes mellitus.
  • Diagnosed cases diabetic peripheral neuropathy.
  • Able to stand and walk independently
  • Balance or postural stability, as indicated by clinical tests (e.g., mini-bestest score below -normative values/21 or less or history of falls/near-falls).
  • Functional reach test with scores 6-10 inches
  • Time up and go up to 14 seconds

Who cannot join

  • History of neurological disorders other than DPN (e.g., stroke, Parkinson's disease, multiple sclerosis).
  • Musculoskeletal disorders affecting lower limb function (e.g., grade 4 osteoarthritis, recent fractures).
  • Uncontrolled cardiovascular conditions (e.g., unstable angina, recent myocardial infarction).
  • Vestibular impairments affecting balance independently of DPN.
  • Diabetic complications that contraindicate exercise (e.g., active foot ulcers, severe retinopathy).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hifza Safdar, DPT contact

+923230501443

hifzasafdar482@gmail.com

Pakistan1 site, 1 recruiting
  • Foundation University College of Physical Therapy

    Islamabad, 44000

    Nida Mushtaq Kayani, MS-NMPT, +923330418548, nida.mushtaq@fui.edu.pk

    Recruiting

Other trials in Pakistan

About this study

Diabetic peripheral neuropathy (DPN) is a common complication of prolonged hyperglycemia that damages peripheral nerves, leading to impaired sensory function, increased fall risk, and reduced quality of life. Balance training has shown promising effects in improving postural stability and reducing fall risk in individuals with DPN by engaging visual, vestibular, and proprioceptive systems and promoting central nervous system adaptation. This randomized controlled trial aims to compare the effects of Reactive Balance Training (RBT) and Task-Oriented Training (TOT) on postural stability in patients with DPN.

The study will be a single-blinded, two-group randomized controlled trial conducted over one year at Foundation University College of Physical Therapy. A sample of 36 participants will be recruited through convenience sampling and randomly allocated into two groups using the coin-toss method. Ethical approval will be obtained from the FUSH ERC, and written informed consent will be obtained after explaining the study procedures, risks, and benefits.

Read more

Postural stability will be assessed using the Posture Assessment Checklist, Mini-BESTest, Functional Reach Test (FRT), and Timed Up and Go (TUG). Group A will receive RBT, while Group B will receive TOT. Each session will last 30-40 minutes, including a 5-7-minute warm-up, 20-30 minutes of group-specific intervention, and a 5-minute cool-down. Participants will receive 60-second rest intervals after every three sets or 8-10 repetitions.

The intervention will continue for six weeks, with three sessions per week, totaling 18 sessions. Assessments will be conducted at baseline, at week 3, and post-intervention at week 6 using the same outcome measures.

Read the detailed description

Diabetic peripheral neuropathy (DPN) is a common complication, resulting from prolonged high blood sugar damaging peripheral nerves. It substantially affects patients by increasing their risk of falls, impairing sensory function, and diminishing overall quality of life. Exercise programs that include balance training have demonstrated promising results in enhancing postural stability and reducing fall risk among patients with DPN .By engaging the visual, vestibular, and proprioceptive systems, balance training facilitates central nervous system adaptation, enhancing the integration of sensory inputs critical for maintaining postural control.This randomized controlled trial aims to compare the effects of Reactive Balance Training and Task-Oriented Training on Postural Stability in Patients with Diabetic Peripheral Neuropathy.The study will be a single -blinding randomized controlled trial, consisting of 2 groups and it will be conducted over a period of 1 year at Foundation University and Collage of Physical Therapy. A calculated sample of 36 subjects will be selected via convenience sampling technique followed by randomization into two groups using coin toss method. Ethical approval will be obtained from FUSH ERC. Individuals fulfilling the inclusion criteria will be selected, followed by written informed consent after explaining the study purpose. Postural stability will be assessed using Posture Assessment Checklist Form, MiniBestest, Funtional Reach test and Time Up and Go in both group.

Each group will have 30-40 minutes divided into 5-7 minutes of warm-up and 20-30 minutes of Reactive balance training or task-specific depending on the group the patient is assigned to follow by 5 minutes cool down period. With every 3 sets or 8-10 repetitions patient will take a 60 seconds break. The total intervention duration will last for 6 weeks. The total number of sessions will be 18 with 3 sessions per week. Each session will begin with a 5-7-minute warm-up consisting of marching in place, ankle pumps and circles, and anterior-posterior (AP) and medial-lateral (ML) weight shifts. This will be followed by 20-30 minutes of group-specific training, with the Reactive Balance Training group performing perturbation-based tasks involving unexpected changes in direction, timing, or surface, while the Task-Oriented Training group will perform functional, goal-directed activities with repetitive practice and progressive challenges.

Each session will conclude with a 5-minute cool-down, including slow walking and stretching of the calf, hamstrings, and hip flexors. Group A will receive reactive balance training with Protocol of 6 Weeks.

In Weeks 1-2 - Familiarization: Warm-up (5-7 min), followed by lean-and-release (forward/backward), gentle AP pelvic perturbations, predictable reactive stepping, and elastic-band perturbations in AP/lateral directions. Cool-down (5 min). Dosage: 3 × 10 perturbations, 60-s rest.

In Weeks 3-4 - Adaptation: Multidirectional lean-and-release, eyes-closed perturbations, foam-surface perturbations, foam + elastic-band perturbations, and eyes-closed elastic perturbations. Dosage: 3 × 10 trials, 60-s rest.

In Weeks 5-6 - Functional/Automatic Phase: High-velocity manual perturbations with narrow/tandem stance, reactive stepping during gait, obstacle negotiation with perturbation, and dual-task reactive balance (counting backward while walking). Dosage: 3 × 10 repetitions, 60-s rest.Safety: Gait belt, therapist guarding, stable support, and appropriate elastic-band use throughout.

Group B will receive Task oriented training of 6 weeks protocol with Weeks 1-2 - Basic Functional Task Acquisition: The objective is to improve postural alignment and basic functional mobility. Participants will perform sit-to-stand from a standard chair, static standing with functional reaching, weight shifting while reaching, forward and lateral stepping, and supported heel-to-toe standing. Dosage: 3 sets × 10 repetitions per task, with 60-second rest.

Weeks 3-4 - Intermediate Functional Task Training: The goal is to enhance dynamic balance and functional independence through sit-to-stand from a low chair, reaching beyond arm's length, multidirectional stepping, obstacle crossing during gait, and step-ups. Difficulty will progress by reducing upper-limb support and increasing task speed and repetitions. Dosage: 3 × 10 repetitions, 60-second rest.

Weeks 5-6 - Advanced \& Real-Life Task Integration: Activities will include carrying objects during sit-to-stand, dual-task walking, turning/pivoting, obstacle negotiation with load carrying, and simulated ADL tasks. Progression will involve a narrow base of support and increased task complexity and environmental variability. Dosage: 3 × 10 repetitions, 60-second rest.

Baseline assessment will be taken at the time of recruitment using MiniBestest, FRT ,TUG tool and Posture Assessment checklist form. Another assessment at 3rd week will be taken and lastly, post intervention assessment will be done by the end of 6th week using the same tools as mentioned previously. Data will be analyzed using SPSS version 22.

Being tested
Reactive Balance Training, TASK ORIENTED TRAINING
Keywords
REACTIVE BALANCE TRAINING, TASK ORIENTED TRAINING, POSTURAL STABILITY, DIABETIC PERIPHERAL NEUROPATHY
Medical subject headings
Diabetic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reactive Balance TrainingProcedure or surgery

    Participants will be briefed about the study objectives, procedures, risks, and benefits. After informed consent, participants will be randomly allocated into two groups using the coin-toss method.

    Group A will receive Reactive Balance Training (RBT) to improve rapid postural responses to unexpected disturbances through progressive external perturbations during standing and walking, emphasizing ankle, hip, and stepping strategies.

    Weeks 1-2 (Familiarization): warm-up (5-7 min), lean-and-release, gentle AP pelvic perturbations, predictable reactive stepping, and AP/lateral elastic-band perturbations, followed by a 5-min cool-down.

    Weeks 3-4 (Adaptation): multidirectional lean-and-release, eyes-closed and foam-surface perturbations, and foam/elastic-band exercises.

    Weeks 5-6 (Functional): high-velocity perturbations, reactive stepping during gait, obstacle negotiation, and dual-task balance. All phases: 3 × 10 trials, 60-s rest, with gait belt, therapist guarding, and stable support

  • TASK ORIENTED TRAININGProcedure or surgery

    Group B will receive a 6-week Task-Oriented Training protocol. Weeks 1-2 (Basic Functional Task Acquisition): sit-to-stand, functional reaching, weight shifting, forward/lateral stepping, and supported heel-to-toe standing to improve postural alignment and mobility. Weeks 3-4 (Intermediate Training): low-chair sit-to-stand, reaching beyond arm's length, multidirectional stepping, obstacle crossing, and step-ups, with reduced upper-limb support and increased speed. Weeks 5-6 (Advanced/Real-Life Integration): sit-to-stand while carrying objects, dual-task walking, turning/pivoting, obstacle negotiation with loads, and simulated ADLs, progressing complexity and environmental variability. All phases will use 3 × 10 repetitions with 60-second rest. Baseline postural stability will be assessed using the Mini-BESTest, Functional Reach Test (FRT), Timed Up and Go (TUG), and Posture Assessment Checklist.

Study groups in NCT07827417
Study groupRoleWhat they receive
Group A- REACTIVE BALANCE TRAININGExperimentalParticipants will receive reactive balance training focused on improving rapid postural responses to unexpected balance disturbances through controlled external perturbations during standing and walking, emphasizing ankle, hip, and stepping strategies with progressive difficulty.
Receives: Procedure: Reactive Balance Training
TASK ORIENTED TRAININGExperimentalParticipants will receive task-oriented training consisting of functional, goal-directed activities such as sit-to-stand, reaching, stepping, walking with direction changes, obstacle negotiation, and weight-shifting, with gradual progression in task complexity
Receives: Procedure: TASK ORIENTED TRAINING

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postural stability

    Postural stability during Reactive Balance will be assessed using MiniBestest test in both groups. The test has a maximum score of 28 points from 14 items that are each scored from 0-2.

    "0" indicates the lowest level of function and "2" the highest level of function.

    If a subject must use an assistive device for an item, score that item one category lower. If a subject requires physical assistance to perform an item, score "0" for that item.

    For Item 3 (stand on one leg) and Item 6 (compensatory stepping-lateral) only include the score for one side (the worse score). For Item 3 (stand on one leg) select the best time of the 2 trials [from a given side] for the score.

    For Item 14 (timed up \& go with dual task) if a person's gait slows greater than 10% between the TUG without and with a dual task then the score should be decreased by a point.

    Measured: 6 weeks

  2. Functional Postural stability

    Functional postural stability will assess using Functional Reach Test. Use to measure ability to maintain stability while reaching forward and controlling the center of mass.

    • If the reach distance exceeds 25.40 cm, it is considered a negative test and a low risk of falling.
    • If the reach distance is within the range of 15.24-25.40 cm, the risk of falling is twice as high during the next six months.
    • If the reach distance is less than 15.24 cm, there is a four times greater risk of falling during the next six months.

    Measured: 6 weeks

  3. Dynamic Postural Stability

    Dynamic Postural Stability will be assess using TIME UP \& GO. A TUG time of ≤10.7 seconds indicates better functional mobility and lower fall risk, whereas a time of >10.7 seconds indicates poorer functional mobility and increased fall risk in individuals with diabetic peripheral neuropathy.

    Posture Assessment Checklist will be use as well in order to check the anterior, posterior and lateral view of posture for ruling out any kind of deformity

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2026
  2. Study start11 Feb 2026
  3. Primary completion10 Jan 2027 (estimated)
  4. Study completion30 Jan 2027 (estimated)

Resources

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
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07827417
Sponsor's protocol ID
FUI/FUCP/CTR/Neuro/HifzaSafdar
Status last verified
Sep 2026
First submitted
14 Sep 2026
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Reactive Balance Training and TASK ORIENTED TRAINING in people with Diabetic Neuropathies and Rehabilitation, 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 7 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: looking for participants now, as of the sponsor's last update on 18 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?

Contact Hifza Safdar, DPT (+923230501443, hifzasafdar482@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postural stability (time frame: 6 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 18 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in